10-K – 2026-02-24 – bbio-20251231.htm

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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
(Mark One)

x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December 31 , 2025

or
o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from                to

Commission File No. 001-38959
BridgeBio Pharma, Inc.
(Exact name of registrant as specified in its charter)

Delaware
State or other jurisdiction of
incorporation or organization
84-1850815
(I.R.S. Employer
Identification No.)

3160 Porter Drive , Suite 250 , Palo Alto , CA
(Address of principal executive offices)
94304
(Zip Code)

Registrant’s telephone number, including area code: ( 650 ) 391-9740
Securities registered pursuant to Section 12(b) of the Act:

Title of each class Trading
Symbol(s) Name of each exchange on which registered
Common Stock, par value $0.001 per share
BBIO
The Nasdaq Global Select Market

Securities registered pursuant to section 12(g) of the Act: NONE
Indicate by check mark if the registrant is a well‑known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes x No o
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes o No x
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No o
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S‑T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes x No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer
x Accelerated filer o
Non-accelerated filer o Smaller reporting company o
Emerging growth company o

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o
Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 726(b)) by the registered public accounting firm that prepared or issued its audit report. x
If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. o
Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). o
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b‑2 of the Act). Yes o No x
The aggregate market value of the voting and non‑voting common equity held by non‑affiliates of the registrant based upon the closing price of the registrant’s Common Stock on The Nasdaq Global Select Market on June 30, 2025 was approximately $ 7.3 billion. Shares of the registrant’s Common Stock held by each executive officer and director and by each other person who may be deemed an affiliate of the Registrant have been excluded from this computation. The determination of affiliate status for this purpose is not necessarily a conclusive determination for other purposes.
On February 12, 2026, there were 193,862,871 shares of the registrant’s Common Stock issued and outstanding.
DOCUMENTS INCORPORATED BY REFERENCE
Specified portions of the registrant’s definitive Proxy Statement to be issued in conjunction with the registrant’s 2025 Annual Meeting of Stockholders, which is expected to be filed not later than 120 days after the registrant’s fiscal year ended December 31, 2025, are incorporated by reference into Part III of this Annual Report. Except as expressly incorporated by reference, the registrant’s Proxy Statement shall not be deemed to be a part of this Annual Report on Form 10‑K.

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BRIDGEBIO PHARMA, INC.
2025 Form 10‑K Annual Report
Table of Contents

Page
PART I

Item 1.
Business
7

Item 1A.
Risk Factors
57

Item 1B.
Unresolved Staff Comments
121

Item 1C.
Cybersecurity
121

Item 2.
Properties
122

Item 3.
Legal Proceedings
122

Item 4.
Mine Safety Disclosures
122

PART II

Item 5.
Market for the Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
123

Item 6.
[Reserved]
124

Item 7.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
125

Item 7A.
Quantitative and Qualitative Disclosures About Market Risk
147

Item 8.
Financial Statements and Supplementary Data
148

Item 9.
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
212

Item 9A.
Controls and Procedures
212

Item 9B.
Other Information
214

Item 9C.
Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
215

PART III

Item 10.
Directors, Executive Officers and Corporate Governance
216

Item 11.
Executive Compensation
216

Item 12.
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
216

Item 13.
Certain Relationships and Related Transactions, and Director Independence
216

Item 14.
Principal Accountant Fees and Services
216

PART IV

Item 15.
Exhibits and Financial Statement Schedules
217

Item 16.
Form 10‑K Summary
223

Signatures
224

In this Annual Report on Form 10-K, unless otherwise stated or as the context requires, references to “BridgeBio,” “the Company,” “we,” “us,” “our” or similar references refer to BridgeBio Pharma, Inc., together with its consolidated subsidiaries.
BRIDGEBIO and ATTRUBY are our registered trademarks in the United States (“U.S.”). BRIDGEBIO, ATTRUBY and BEYONTTRA are our registered trademarks in the European Union (“EU”), the United Kingdom (“UK”) and Japan. All other brand names and service marks, trademarks and other trade names appearing in this report are the property of their respective owners.
We use the brand name for our products when we refer to the product that has been approved and with respect to the indications on the approved label. Otherwise, including in discussions of our achondroplasia, autosomal dominant hypocalcemia type 1 (ADH1), and limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9) development programs, we refer to our product candidates by their scientific (or generic) name or BridgeBio Pharma (“BBP”) developmental designation. When referring to our commercial product that has been approved in (i) the U.S. and (ii) the EU, Japan, and the UK, as applicable, we use both names Attruby TM and Beyonttra TM – e.g., “Our commercial organization focuses on supporting the appropriate use of Attruby and Beyonttra in the markets where this product has been approved.”
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Special Note Regarding Forward‑Looking Statements
This Annual Report on Form 10‑K contains forward‑looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such forward‑looking statements involve substantial risks, uncertainties and assumptions. All statements in this Annual Report on Form 10‑K, other than statements of historical fact, including, without limitation, statements regarding our strategy, future operations, future operating expenses, future financial position, future revenue, projected costs, prospects, plans, intentions, expectations, goals and objectives may be forward‑looking statements. The words “anticipates,” “approximately,” “believes,” “could,” “designed,” “estimates,” “expects,” “goal,” “intends,” “may,” “objective,” “plans,” “potential,” “predicts,” “projects,” “pursuing,” “seeks,” “should,” “will,” “would” and similar expressions (including the negatives thereof) are intended to identify forward‑looking statements, although not all forward‑looking statements contain these identifying words. The forward-looking statements in this report include, but are not limited to, statements about:
• the commercial success of Attruby TM (acoramidis), including our expectations regarding the size and growth potential of the commercial markets for Attruby;
• the success, cost and timing of our clinical development of our product candidates, including the progress of, and results from and data readouts for, our ongoing Phase 2 and Phase 3 clinical trials of low-dose infigratinib for achondroplasia, our Phase 3 clinical trial of BBP-418 for LGMD2I, our ongoing Phase 3 clinical trial of encaleret for ADH1, and our ongoing Phase 1/2 clinical trial of BBP-812 for Canavan disease, and the clinical timeline for our new antibody deplete program for ATTR-CM, as well as the potential indications for each;
• our ability to continue planned preclinical and clinical development of our respective development programs, and the timing, cost and success of any such continued preclinical and clinical development and planned regulatory submissions;
• our ability to initiate, recruit and enroll patients in and conduct our clinical trials at the pace that we project;
• the expected timing of our submissions, including New Drug Applications (“NDAs”) to the U.S. Food and Drug Administration (the “FDA”), and similar submissions with foreign regulatory authorities, our Investigational New Drug applications (“INDs”), our potential receipt of U.S. approval and commencement of commercial launch for BBP-418, encaleret, and infigratinib, subject to such approval and our anticipated interaction with and feedback from the FDA and similar regulatory authorities;
• our plans to implement certain development strategies, including our ability to attract and retain potential collaborators with development, regulatory and commercialization expertise;
• our ability to obtain and maintain regulatory approval of our product candidates in any of the indications for which we are developing or we plan to develop, and any related restrictions, limitations or warnings in the label of any of our product candidates, if approved;
• our ability to successfully commercialize our current product candidates, if approved, and any other product candidates we may identify and pursue, if approved, including our ability to successfully build a specialty sales force and commercial infrastructure to market our current product candidates and any other product candidates we may identify and pursue;
• our ability to compete with companies currently marketing approved treatments or engaged in the development of treatments that may become available for any of the indications that our product candidates are designed to target;
• our reliance on third parties to conduct our clinical trials and to manufacture drug substance and drug product for our commercial product and certain of our product candidates for use in our clinical trials;
• our ability to contract with and the performance of our and our collaborators’ third-party suppliers and manufacturers;
• the pricing and reimbursement of our product candidates, if approved;
• the size and growth potential of the markets for our current product candidates or other product candidates we may identify and pursue, and our ability to serve and gain acceptance by those markets;
• our ability to identify and advance through clinical development any additional product candidates;
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• the impacts of public health crises or macroeconomic factors that could impact our business, such as the effects of the ongoing conflicts in the Ukraine or in Israel and the Gaza Strip on the global economy; supply chain and inflationary pressures, or significant political, trade or regulatory developments in the jurisdictions in which we may sell our products or conduct our operations;
• our ability to retain and recruit key personnel;
• the success of competing therapies that are or may become available;
• our ability to obtain and maintain adequate intellectual property rights for our product candidates and our ability to operate our business without infringing on the intellectual property rights of others;
• our expectations regarding government and third-party payor coverage and reimbursement;
• our estimates of our expenses, ongoing losses, capital requirements and our use of cash resources, and our needs for or ability to pay for debt interests and obtain additional financing to complete the clinical trials of any of our product candidates;
• the impact of laws and regulations in the United States and foreign countries;
• our financial performance, including our anticipated funding to support the potential launch of three additional medicines globally;
• adverse developments affecting the financial services industry, such as actual events or concerns involving liquidity, defaults, or non-performance by financial institutions or transactional counterparties; and
• developments and projections relating to our competitors or our industry.
We may not actually achieve the plans, intentions, expectations or objectives disclosed in our forward‑looking statements and the assumptions underlying our forward‑looking statements may prove incorrect. Furthermore, if our forward‑looking statements prove to be inaccurate, the inaccuracy may be material. Therefore, you should not place undue reliance on our forward‑looking statements, and you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. Actual results or events could differ materially from the plans, intentions, expectations and objectives disclosed in the forward‑looking statements that we make. Important factors that we believe could cause actual results or events to differ materially from our forward‑looking statements include, but are not limited to, those listed under “Risk Factors” in Item 1A of Part I, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Item 7 of Part II and elsewhere in this Annual Report on Form 10‑K. Our forward‑looking statements in this Annual Report on Form 10‑K are based on current expectations as of the date hereof and we do not assume any obligation to update any forward‑looking statements on account of new information, future events or otherwise, except as required by law.
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RISK FACTOR SUMMARY
Below is a summary of the principal factors that make an investment in our common stock speculative or risky. This summary does not address all of the risks that we face. Additional discussion of the risks summarized in this risk factor summary, and other risks that we face, can be found below under the heading “Risk Factors” and should be carefully considered, together with other information in this Annual Report on Form 10-K and our other filings with the U.S. Securities and Exchange Commission (the “SEC”) before making investment decisions regarding our common stock.
• Our business is substantially dependent on the commercial success of Attruby and Beyonttra. The continued commercial success of this product, along with our product candidates, if approved, will depend upon the degree of market acceptance by physicians, patients, healthcare payors, and others in the medical community.
• If our sales and marketing capabilities for Attruby and Beyonttra, and our future product candidates, if approved, are not effective or we are unable to establish sales and marketing capabilities or enter into and maintain our agreements with third parties to sell and market Attruby and Beyonttra or any future product candidates approved for commercial sale, we may be unsuccessful in our commercial efforts.
• Our profitability will depend significantly on our ability to sell enough product at competitive prices and on the availability of adequate coverage and reimbursement through governmental or private third-party payors.
• Our future growth may depend, in part, on our ability to penetrate foreign markets, where we would be subject to additional regulatory burdens and other risks and uncertainties.
• If we fail to comply with healthcare laws, we could face substantial penalties and our business, operations and financial conditions could be adversely affected.
• Healthcare legislative measures aimed at reducing healthcare costs may have a material adverse effect on our business and results of operations.
• If we fail to comply with our reporting and payment obligations under the Medicaid Drug Rebate program or other governmental pricing programs, we could be subject to additional reimbursement requirements, penalties, sanctions and fines, which could have a material adverse effect on our business, financial condition, results of operations and growth prospects.
• Federal legislative and regulatory efforts to implement reference pricing or most-favored-nation pricing models could impact our product revenues and materially harm our business.
• We face significant competition in an environment of rapid technological and scientific change, and there is a possibility that our competitors may achieve commercial success or regulatory approval before us or develop therapies that are safer, more advanced or more effective than ours, which may negatively impact our ability to successfully market or commercialize any product candidates we may develop and ultimately harm our financial condition.
• We may encounter substantial delays in clinical trials or may not be able to conduct or complete clinical trials on the expected timelines, if at all.
• Results of earlier studies or clinical trials may not be predictive of future clinical trial results, and initial studies or clinical trials may not establish an adequate safety or efficacy profile for our product candidates to justify proceeding to advanced clinical trials or an application for regulatory approval.
• Preliminary, interim or topline data from our clinical trials that we announce or publish from time to time may change as more patient data become available or as additional analyses are conducted, and as the data are subject to audit and verification procedures that could result in material changes in the final data.
• Although we have obtained marketing authorization for Attruby, we have multiple product candidates in our development pipeline that are still in preclinical or clinical development, which is a lengthy and expensive process with uncertain outcomes and the potential for substantial delays. We cannot give any assurance that any of our pipeline product candidates will receive regulatory approval, which is necessary before they can be commercialized.
• If we are unable to obtain regulatory approval in one or more jurisdictions for any product candidates that we may identify and develop, our business will be substantially harmed.
• Our clinical trials may fail to demonstrate substantial evidence of the safety and efficacy of product candidates that we may identify and pursue for their intended uses, which would prevent, delay or limit the scope of regulatory approval and commercialization.
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• We rely entirely on third parties for the manufacturing of commercial supplies of Attruby and Beyonttra and for supplies of our product candidates that we may develop. Our business could be harmed if those third parties fail to provide us with sufficient quantities of drug product, or fail to do so at acceptable quality levels or prices.
• If the contract manufacturing facilities on which we rely do not continue to meet regulatory requirements or are unable to meet our supply demands, our business will be harmed.
• If we are unable to obtain and maintain sufficient intellectual property protection for Attruby and Beyonttra and our product candidates, including low-dose infigratinib, BBP-418, and encaleret, or if the scope of the intellectual property protection obtained is not sufficiently broad, our competitors could develop and commercialize products or product candidates similar or identical to ours, and our ability to successfully commercialize our product candidates may be impaired.
• Patent terms may be inadequate to protect our competitive position on product candidates for an adequate amount of time.
• Product liability lawsuits against us could cause us to incur substantial liabilities and could limit commercialization of any product candidates that we may develop.
• We may require substantial additional funding to achieve our business goals. If we are unable to obtain this funding when needed and on acceptable terms, we could be forced to delay, limit or terminate our product development and commercialization efforts.
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PART I

ITEM 1. BUSINESS
Overview
A New Type of Biopharmaceutical Company
BridgeBio Pharma, Inc. is a commercial-stage, multi-product biopharmaceutical company organized around a portfolio operating model to discover, develop, and deliver medicines for patients with genetic diseases. We seek to translate advances in genetic science into therapies for patient populations with significant unmet medical needs.
Since our founding 10 years ago, we have advanced multiple programs from discovery through regulatory approval and commercialization. To date, more than 8,500 patients have been treated with our approved medicines, and we have obtained U.S. Food and Drug Administration (the “FDA”) approval for three products. We believe our decentralized hub and spoke model enables us to achieve clinical proof-of-concept with speed and efficiency, demonstrated by an average investment per program of less than $40.0 million to proof-of-concept data and less than $10.0 million to reach Investigational New Drug (“IND”) submission. This efficiency allows us to work on a broad range of scientifically compelling therapies, including programs for underserved conditions which more traditional biopharmaceutical models might leave on the shelf but we believe can be developed on a Net Present Value (“NPV”)-positive basis in our portfolio.
In addition to our commercial products led by Attruby, we plan to pursue regulatory submissions for several advanced product candidates, including therapies for achondroplasia, limb-girdle muscular dystrophy type 2I/R9, and autosomal dominant hypocalcemia type 1, which have all recently released positive Phase 3 data. Since inception, we have generated 19 investigational new drug applications and contributed to more than 70 peer-reviewed scientific publications, reflecting our continued focus on advancing the understanding and treatment of genetic diseases.
What BridgeBio Is Today
Today, BridgeBio is a commercial-stage biopharmaceutical company with multiple approved products, a growing global commercial footprint, and a portfolio of late-stage development programs with regulatory pathways that we believe to be well-defined. Over the past year, we have demonstrated our ability to translate research and development (“R&D”) efforts into successful commercial execution.
Our largest commercial product, acoramidis, was approved by the FDA in November 2024 for the treatment of transthyretin amyloid cardiomyopathy and is being commercialized by BridgeBio in the United States (under the brand name Attruby™). Outside the United States, acoramidis is marketed as Beyonttra™ and is commercialized through strategic collaboration partners, including Bayer in Europe and Alexion in Japan, as well as directly by BridgeBio in certain international markets.
Our achievements in 2025 demonstrate strong commercial momentum with the potential for Attruby to become a significant commercial asset over time.
In parallel, we are advancing multiple Phase 3 programs across rare and genetically defined diseases and are well advanced in commercial launch preparations following the recent positive data readouts from our infigratinib, BBP-418, and encaleret programs. We believe each of these programs has the potential to serve a significant patient population with best-in-class or first-in-class medicines. On a standalone basis, we believe the commercial expectations for each of these assets are promising and demonstrate the effect of our decentralized R&D engine. During 2026, we expect to progress each of these programs towards anticipated approvals in the United States and Europe and are actively preparing for the worldwide commercial launches of these products, if approved.
Lastly, our continued focus on early-stage development includes various expansion indications and we plan to initiate a registrational study of encaleret in chronic hypoparathyroidism and pediatric ADH1 in 2026 alongside studying infigratinib for hypochondroplasia in 2027. We are also developing the next generation of transthyretin-mediated amyloidosis (“ATTR-CM”) treatment through a depleter program to explore the potential of disease reversal on ATTR-CM. Finally, we maintain our minority equity interests in GondolaBio, LLC and BridgeBio Oncology Therapeutics, Inc., which are separate companies spun out of BridgeBio and allows us to retain exposure to a broad pipeline of early-stage development opportunities, while remaining focused on advancing and commercializing our core portfolio.
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Our Objective Function and How We Define Success
Our corporate objective at BridgeBio is to develop medicines that meaningfully improve patient outcomes and thereby maximize the positive impact we can have on the quality-adjusted life-years of the patients we serve as quickly as possible. We pursue this objective by advancing programs underpinned by clear genetic drivers, established disease mechanisms, and therapeutic approaches designed to address the underlying cause of disease.
We apply a consistent decision framework that considers biological validation, probability of technical success, development timelines, capital requirements, and expected risk-adjusted value. We evaluate performance at the portfolio level based on overall progress across development milestones, regulatory approvals, and commercialization, as well as our ability to reallocate resources as data emerge. This portfolio-based approach allows us to advance multiple programs in parallel and, over time, support a self-reinforcing “flywheel” of portfolio development.
The following graphic illustrates our approach to program selection:
Exhibit 1 1

As shown in Exhibit 1 above, we apply a quantitative approach to evaluating our programs and our Company as a whole, which typically includes the following factors:
• Scientifically grounded program selection: Each program is selected based on strong biological validation, including a clear understanding of disease mechanism and a therapeutic approach designed to address a well-defined genetic condition. We believe this focus supports more predictable development outcomes and a higher probability of technical success over time.
• Focus on differentiated medicines: We seek to develop medicines that have the potential to be first-in-class or best-in-class within their respective fields. In evaluating differentiation, we consider factors such as clinical outcomes, timing of therapeutic effect, safety profile, and overall treatment burden, using available clinical data and comparative assessments where appropriate.
• Economic sustainability at the program level: Each program is evaluated with the objective of supporting long-term economic sustainability on a risk-adjusted basis. We consider factors such as development timelines, capital requirements, and expected returns in determining whether to advance or continue investment in a program.
• Capital efficiency as an operating principle: We emphasize disciplined capital deployment throughout research and development, with a focus on managing costs through early development stages while maintaining flexibility to adjust investment based on emerging data.

1 Shukla, C., Tendler, I., Kumar, N. and Lo, A.W. (2026) Genetic targets, financial creativity: BridgeBio’s model for sustainable drug development. Drug Discovery Today, 31(1), pp. 1–7.
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Our Hub-and-Spoke Operating Model
BridgeBio operates a decentralized, hub-and-spoke model designed to maximize our probability of success over time. This model is intended to allow multiple programs to advance concurrently while enabling capital and other resources to be allocated flexibly as data evolves, consistent with our approach to managing development risk over time.
Our “spokes” consist of program-specific teams responsible for research, development, and scientific leadership for individual conditions or product candidates. These teams are accountable for program strategy and day-to-day development decisions. Each spoke is structured as a dedicated, minimum viable development unit, concentrating only the capabilities required to advance a program efficiently while minimizing organizational complexity. Furthermore, within each spoke we focus scientific effort on the rate-limiting questions for program advancement, reducing non-essential experimentation and supporting faster progression to key development milestones.
Our “hub” consists of centralized functions that provide shared business and finance operations, clinical and regulatory expertise, and our commercial platform. This structure allows us to separate asset-level scientific development from enterprise-level execution, support disciplined capital allocation, and scale our commercial platform for existing and future commercial products.
By maintaining lean, asset-focused teams supported by shared services, the model allows BridgeBio to be “led by the science” while retaining financial discipline in program development and preserve our flexibility to advance or discontinue programs based on the latest data.
Portfolio Overview
The following portfolio tables summarize our products for which we have previously received regulatory approval and our commercial products and Phase 3 registrational programs, which include our most advanced assets and key value drivers in our portfolio.
The tables also include selected early-stage clinical development programs that may contribute to the long-term expansion of our portfolio, subject to clinical progress and regulatory outcomes.

Commercial Products Indication Status

Products marketed by BridgeBio
Attruby (acoramidis) Transthyretin Amyloidosis (ATTR – CM) Approved
Products not marketed by BridgeBio
Beyonttra (acoramidis) Transthyretin Amyloidosis (ATTR – CM) Approved
Nulibry (fosdenopterin) Molybdenum Cofactor Deficiency (MoCD) Type A Approved
Truseltiq (infigratinib) Cholangiocarcinoma Approved (withdrawn)

Phase 3 Registrational and Selected Phase 2/3
Clinical Development Programs Indication Status
Infigratinib Achondroplasia (ACH) Positive Topline Readout
BBP-418 Limb-Girdle Muscular Dystrophy Type 2I/R9 (LGMD2I/R9) Positive Interim Analysis Topline Readout
Encaleret Autosomal Dominant Hypocalcemia Type 1 (ADH1) Positive Topline Readout
Infigratinib Hypochondroplasia (HCH) Fully Enrolled Phase 2 study
Encaleret Chronic Hypoparathyroidism (CHP) Phase 3 study initiating in 2026

In addition, we maintain a broad set of early-stage development programs and strategic equity investments, as reflected in the following pipeline overview. Together, these clinical and pre-clinical assets may develop into a meaningful driver of future portfolio value and long-term growth potential, subject to clinical progress and regulatory outcomes.
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Key Highlights
• Attruby commercial and clinical momentum: In 2025, Attruby generated significant commercial uptake in the United States, supported by continued prescription growth, expanding prescriber adoption, and additional clinical data demonstrating early and sustained reductions in mortality and cardiovascular outcomes in patients with ATTR-CM.
• Beyonttra commercial momentum in Europe: Beyonttra demonstrated strong early uptake in Europe, led by Germany, where the product achieved an estimated new-to-brand prescription (“NBRx”) share of more than 50% within the first year of launch, reflecting the strong commercial potential of the product in Europe.
• Positive Phase 3 results for infigratinib in achondroplasia: In February 2026, we presented topline results from the PROPEL 3 global pivotal study of oral infigratinib in children living with achondroplasia. PROPEL 3 successfully met all primary and secondary endpoints with no serious adverse events related to the drug study. Based on these results, we plan to submit a New Drug Application (“NDA”) to the FDA and a Marketing Authorization Application (“MAA”) to the European Medicines Agency (“EMA”) in the second half of 2026.
• Positive Phase 3 results for encaleret in ADH1: In October 2025, we presented topline results from the Phase 3 CALIBRATE trial of encaleret in autosomal dominant hypocalcemia type 1, which demonstrated statistically significant normalization of serum and urinary calcium versus standard of care. We plan to submit an NDA to the FDA in the first half of 2026.
• Positive Phase 3 results for BBP-418 in LGMD2I/R9: In October 2025, we presented Topline data from the Phase 3 FORTIFY study showed BBP-418 achieved its primary and key secondary endpoints in limb-girdle muscular dystrophy type 2I/R9. We plan to submit an NDA to the FDA in the first half of 2026.
• International approvals for Beyonttra: In the first half of 2025, Beyonttra received approval for the treatment of transthyretin amyloid cardiomyopathy from the European Commission and the regulatory authorities in the United Kingdom and Japan.

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Commercial Products
ATTRUBY
Summary
Attruby (acoramidis), previously known as AG10, is a next-generation oral small molecule near-complete transthyretin (“TTR”) stabilizer, and was approved by the FDA in 2024 for the treatment of cardiomyopathy of wild-type or ATTR-CM in adults to reduce cardiovascular death and cardiovascular-related hospitalization. Acoramidis has demonstrated differentiated clinical benefit in ATTR patients in the Phase 3 ATTRibute-CM study and its open label extension. Attruby is the first and only approved product with a label specifying near-complete stabilization of TTR.
In 2025, Attruby generated $362.4 million in U.S. net product revenues. These results correspond with increasing patient adoption and prescriber utilization. As of February 20, 2026, we have achieved:
• 7,804 unique patient prescriptions 2 in the United States
• 1,856 prescribing healthcare professionals 3 , demonstrating the broad and deep penetration of the Attruby story
• An estimated >25% share of NBRx for Attruby
In February 2025, the European Commission approved acoramidis, under the brand name Beyonttra, for the treatment of adults with ATTR-CM in Europe. In 2025 regulatory approvals for the marketing of Beyonttra were also granted in the United Kingdom and Switzerland. We have licensed commercial rights in Europe to Bayer who are commercializing Beyonttra in all EU member states, the United Kingdom, Switzerland and Turkey under our Exclusive License Agreement with Bayer signed in March 2024.
The European launch of Beyonttra has delivered strong early uptake, highlighting the product’s significant commercial potential in the region. Germany has been the leading market, with Beyonttra achieving an estimated NBRx share of more than 50% within the first year of launch.
In March 2025, the Japanese Ministry of Health, Labor and Welfare approved acoramidis, under the brand name Beyonttra, for the treatment of adults with ATTR-CM in Japan. We have licensed commercial rights in Japan to Alexion, AstraZeneca Rare Disease, under the Exclusive License Agreement signed in September 2019 with our subsidiary, Eidos Therapeutics, Inc.
In 2025, Beyonttra contributed $105.0 million in license and services revenue following approvals in Europe and Japan. Additionally, we received $11.4 million in royalty revenue primarily earned on net product sales of Beyonttra in Europe and Japan. In 2026, we plan to continue our collaborations with Bayer and Alexion to drive continued growth in Europe and Japan, respectively.
Market Opportunity
We believe that the total market for ATTR therapeutic interventions will continue to grow for the foreseeable future as the population of diagnosed patients increases because of heightened disease awareness and the increased adoption of non-invasive diagnostic techniques. We believe the potential total global addressable market could exceed $20.0 billion. The number of estimated diagnosed ATTR-CM patients in the United States has grown from fewer than 5,000 in 2019 to more than 50,000 in 2025. As such, we believe that there could be a significant population of either newly diagnosed or undiagnosed patients who have not previously been treated with a disease-modifying therapy and could be treated with acoramidis. We believe acoramidis will also be an important treatment option for patients inadequately managed by the current treatment. Further, we believe that acoramidis has the potential to be a best-in-class stabilizer for the treatment of ATTR-CM and that stabilization is likely to remain the preferred mechanism. We are also encouraged by the potential that depleters could offer for ATTR-CM patients with existing amyloidogenic TTR deposits and are exploring potential combination therapy regimens.

2 Unique patient prescriptions represent the cumulative total number of distinct patients in the United States who have received at least one prescription for Attruby since launch, across all distribution channels.
3 Unique prescribing healthcare professionals represents the cumulative total number of distinct healthcare providers in the United States who have prescribed Attruby at least since launch.
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Design Overview
ATTR is a disease caused by destabilization of TTR tetramers resulting in progressive amyloid deposition. TTR is a protein that occurs naturally in the form of a tetramer, consisting of four identical subunits, or monomers, and performs multiple physiologic roles, including the transport of thyroxine and retinol. In ATTR, TTR tetramers become destabilized due to a mutation in the TTR gene or as part of the natural aging process. Destabilized TTR dissociates into monomers, self-aggregates, and assembles into fibrils that are deposited, predominantly in the heart and nervous system, driving disease pathophysiology. TTR itself is not toxic – it is a normal and essential protein in humans, and humans cannot be born in the absence of the TTR gene. Higher serum TTR levels are associated with increased longevity and reduced cardiovascular and dementia risk in multiple independent studies. Higher serum levels also reflect greater TTR stability. The ATTR disease process begins only when TTR destabilizes to release its monomers, which may then re-aggregate and misfold into amyloid fibrils.
Cardiomyopathic ATTR is commonly categorized by its genotypic cause with wild-type ATTR cardiomyopathy (“ATTRwt-CM”), which results from an age-related process, and variant ATTR cardiomyopathy (“ATTRv-CM”). Both forms of the disease are progressive and fatal, though ATTRv-CM patients’ condition often presents at an earlier age and progress more rapidly than patients with wild-type disease, which translates into a worse prognosis in many such patients. ATTRwt-CM and ATTRv-CM patients generally present with symptoms later in life (older than 50) and have median life expectancies of two to five years from diagnosis if untreated. Progression of both forms of the disease can cause significant disability, impact productivity and quality of life, and create a significant economic burden due to the costs associated with patient need for supportive care. As the disease progresses, ATTRwt-CM and ATTRv-CM patients may experience recurrent hospitalizations and repeated interventions.
The worldwide estimated prevalence of ATTRwt-CM and ATTRv-CM is greater than 400,000 and 40,000, respectively. We believe that cardiomyopathic ATTR is significantly underdiagnosed today. For example, recent literature has suggested that between 10% to 13% of patients diagnosed with heart failure with preserved ejection fraction may have undiagnosed ATTR-CM. The heart failure with preserved ejection fraction segment represents approximately half of the 6.0 million to 7.0 million estimated people with heart failure in the United States. With the increasing availability of disease-modifying therapeutics, disease awareness is heightened, and the diagnosis rate will likely continue to grow.
We believe the population of diagnosed ATTR-CM patients is also growing rapidly due to the shift to an accurate and reliable non-invasive diagnostic imaging technique. Historically, a heart biopsy was required to make a diagnosis of ATTR-CM. Recently, however, it has been shown that scintigraphy with technetium-labeled radiotracers paired with single-photon emission computerized tomography (“SPECT”) imaging is a highly accurate, non-invasive, and cost-effective method for ATTR-CM diagnosis. We believe that both increased disease awareness and availability of this non-invasive diagnostic imaging technique allow for earlier diagnosis of ATTR-CM patients and the identification of previously misdiagnosed patients.
Design Criteria
Acoramidis is a commercially available, orally administered, small molecule TTR stabilizer that treats ATTR at its source. We designed acoramidis to meet two primary criteria – to preserve circulating native TTR and to reduce amyloid deposition by minimizing toxic monomer formation.
TTR is a protein that has been highly conserved throughout evolution, and which is abundant in the plasma with relatively rapid turnover requiring sustained metabolic energy expenditure. Thus, we seek to achieve maximal stabilization of the TTR tetramer rather than elimination.
Acoramidis has been shown in preclinical studies and clinical trials to prevent the dissociation of tetrameric TTR into monomers, and in preclinical studies, to reduce the rate of amyloid fibril formation. In addition, it has been shown to lead to increased circulating levels of tetrameric TTR. Acoramidis was designed to bind TTR in a way that causes TTR’s conformational structure to mimic that of the well-characterized T119M variant, a naturally occurring rescue mutation that super stabilizes the TTR tetramer. The T119M variant has been observed to prevent the dissociation of TTR tetramers into monomers; T119M tetramers dissociate 40-fold more slowly than wild-type tetramers in biochemical assays. Known as a trans-allelic trans-suppressor, individuals who coinherit the T119M rescue mutation along with a TTR-destabilizing mutation are protected against the development of ATTR.
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In third-party clinical trials of tafamidis, another orally administered, small molecule TTR stabilizer, interventional approaches that increased TTR stabilization led to improved outcomes in this disease, as measured by all-cause mortality and cardiovascular-related hospitalizations, and were correlated with increases in serum TTR. Further, based on genetic data, there is a correlation between the level of TTR stabilization, serum TTR levels and disease severity. As a result, we believe that serum TTR is a predictive biomarker for disease prognosis and that observed data from the ATTRibute-CM study showed increases in serum TTR from baseline levels were correlated with reductions in CVH and CVM over 30 months. Based on results from comparative nonclinical studies, we believe that acoramidis has the potential to stabilize TTR to a greater extent than other TTR stabilizers.
Summary of Key Clinical Outcomes and Development Milestones in 2025

Announcement Date Study Key Findings
March 31, 2025 ATTRibute-CM Variant Subgroup Analysis Acoramidis showed statistically significant reduction in the risk of ACM or first CVH in ATTR-CM Variant patients with a 59% risk reduction versus placebo through Month 30
May 13, 2025 ACT-EARLY First participant dosed in ACT-EARLY, the first clinical study evaluating acoramidis for primary prevention in asymptomatic carriers of pathogenic TTR variants
May 19, 2025 ATTRibute-CM Serum TTR Biomarker Analysis Early and sustained increases in serum TTR levels were observed to be independently associated with improved survival
May 20, 2025 ATTRibute-CM Post-Hoc Analysis Acoramidis reduced cardiovascular hospitalizations due to atrial fibrillation/atrial flutter by 43% and reduced new-onset AF/AFL by 17% versus placebo in patients without prior AF history
August 30, 2025 ATTRibute-CM Open-Label Extension (OLE) Acoramidis demonstrated statistically significant reduction in cardiovascular mortality with a 44% hazard reduction through Month 42
September 28, 2025 ATTRibute-CM Cumulative Cardiovascular Outcomes Analysis Acoramidis was observed to begin reducing the risk of CVM and recurrent CVH within the first month of treatment with a 49% hazard reduction versus placebo at Month 30
November 8, 2025 ATTRibute-CM Variant Subgroup Analysis Acoramidis demonstrated statistically significant reduction in ACM or first CVH in the Variant V142I (V122I) population with a 69% risk reduction versus placebo through Month 30

NULIBRY
Fosdenopterin, an intravenous formulation of synthetic cyclic pyranopterin monophosphate, was developed as a treatment for molybdenum cofactor deficiency (“MoCD, Type A”). Fosdenopterin, under the brand name NULIBRY, was approved by the FDA in February 2021 for patients with MoCD Type A.
MoCD Type A is an ultra-rare condition, with estimated incidence ranging from approximately one in 341,000 to one in 411,000 live births. As a result, the addressable patient population is extremely small, and the commercial market is limited in absolute size. Prior to the approval of NULIBRY, there were no approved therapies for any form of MoCD, and treatment was limited to supportive and symptomatic care.
Upon FDA approval in February 2021, NULIBRY became the first and only approved therapy for this condition. The approval was supported by orphan drug designation and resulted in the issuance of a Priority Review Voucher.
In March 2022, Sentynl Therapeutics, Inc. acquired global rights to NULIBRY and assumed responsibility for its ongoing development, manufacturing, and commercialization worldwide. NULIBRY remains commercially available. BridgeBio did not generate significant royalty revenue from product sales of NULIBRY during 2025.
TRUSELTIQ
TRUSELTIQ (infigratinib) is a selective fibroblast growth factor receptor (“FGFR”) inhibitor. In May 2021, the FDA granted accelerated approval to TRUSELTIQ for the treatment of cholangiocarcinoma with an FGFR2 fusion or rearrangement, as detected by an FDA-approved test.
In May 2023, the FDA announced the withdrawal of the accelerated approval for TRUSELTIQ. Although TRUSELTIQ is no longer commercially available, we continue to utilize related intellectual property in ongoing clinical investigations involving other FGFR-related conditions.
Commercialization and Product Support
We have built our commercial organization in the U.S. to support the commercialization of Attruby in the U.S. Following FDA approval in November 2024, we launched Attruby in the U.S. with a sales force appropriately sized to call on all ATTR-CM treatment centers in the U.S. and other community cardiologists who treat ATTR-CM patients in the U.S.
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Our sales force is focused on promoting Attruby to healthcare providers and effectively communicating product benefits. Attruby is the first and only approved product for adults with ATTR-CM in the U.S. with a label specifying near-complete stabilization of TTR. The full prescribing information (“PI”) for Attruby can be accessed at www.ATTRUBY.com.
We estimate that there are approximately 240,000 ATTR-CM patients in the U.S., part of a global patient population of around 500,000.
Attruby has already demonstrated category-leading results including:
• Demonstrated effects on clinical outcomes and quality of life, with effects observed as early as one month and three months, respectively
• 42% reduction in composite of all-cause mortality and recurrent cardiovascular-related hospitalization events at Month 30
• 50% reduction in the cumulative frequency of cardiovascular-related hospitalization events at Month 30
We believe these results support the strong value proposition of Attruby and underscore the opportunity to improve the lives of patients with ATTR-CM. To ensure patients can access and afford this treatment, we have established several industry-leading access programs. We also offer a Commercial Co-Pay program for eligible commercial patients, which can provide access to Attruby for free. We also offer Attruby for free to patients who are uninsured or underinsured through our Patient Assistance Program (“PAP”) and provide a free 28-day trial to patients new to Attruby. For Medicare patients, the Inflation Reduction Act (“IRA”) limited out-of-pocket costs (“OOP”) and capped OOP at $2,000.00 annually, effective January 1, 2025. Additionally, patients participating in the Medicare Prescription Payment Program are eligible to spread their out-of-pocket costs into monthly payments, not to exceed $167.00 per month, inclusive of all Part D medications. Dual-eligible and Low-Income Subsidy patients will pay no more than $13.00 per month.
To ensure ease of access, Attruby is distributed in the U.S. through a limited network of specialty pharmacies, specialty distributors and third-party logistics providers. Medication can be dispensed directly to patients or directly from approved hospital pharmacies to patients.
We currently partner with Bayer for the commercialization of Beyonttra in Europe and Alexion for commercialization of Beyonttra in Japan. We plan to leverage a full-service distribution partnership to support commercialization of Beyonttra in additional markets.
We continue to evaluate our commercialization strategy as we advance each product candidate through clinical development and to regulatory approval. In any core markets outside of the United States that we may identify, we may elect to utilize strategic partners, distributors or contract management and sales organizations to assist in the commercialization of any of our approved products in certain geographies.
Manufacturing
We do not own or operate, and currently have no plans to establish, any manufacturing facilities. We currently utilize third-party contract manufacturing organizations (“CMOs”) for all required raw materials, drug substance, drug product and packaging for our commercial products and for our preclinical research and our ongoing clinical trials of our product candidates. We have secured long-term manufacturing agreements with CMOs to produce and support our commercial sale of Attruby in the U.S., and of Beyonttra in certain markets outside of the United States.
We intend to continue to rely on CMOs for later-stage development and commercialization of our product candidates, including any additional product candidates that we may identify. Although we rely on CMOs, we have employees and third-party consultants with extensive manufacturing experience to oversee the relationships with our contract manufacturers. Refer to Note 11 of Part II - Item 8. Financial and Supplementary Data - Notes to Consolidated Financial Statements of this Annual Report on Form 10-K for further details.
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Development Portfolio – Phase 3 Registrational Candidates
Our Phase 3 portfolio comprises multiple programs with positive late-stage clinical data advancing toward potential regulatory submissions. Together, these programs represent the most mature assets in our portfolio and illustrate the breadth and commercial potential of our in-house development engine.
Infigratinib for Achondroplasia
Summary
We are developing low-dose infigratinib, an oral, selective FGFR1-3 tyrosine kinase inhibitor, for the treatment of children with achondroplasia and hypochondroplasia, two skeletal dysplasia programs caused by gain-of-function mutations in the fibroblast growth factor 3 (“FGFR3”) gene. Infigratinib acts directly at the pathophysiological cause of achondroplasia by inhibiting overactive FGFR3 signaling and addresses the underlying genetic driver of disease.
Our objective with low-dose infigratinib is to provide a differentiated treatment option that targets FGFR3 at its source while offering an oral route of administration that reduces treatment burden for children and their families.
Infigratinib has received Breakthrough Therapy Designation, and Rare Pediatric Disease Designation from the FDA for achondroplasia, as well as Fast Track Designation and Orphan Drug Designation for both achondroplasia and hypochondroplasia.
PROPEL 3 Top-Line Readout
On February 12, 2026, we reported positive Phase 3 Topline results from our PROPEL 3 study for oral infigratinib with the first statistically significant improvements in body proportionality in achondroplasia.
PROPEL 3 is a Phase 3, multicenter, randomized, double-blind, placebo-controlled pivotal study evaluating low-dose infigratinib at 0.25 mg/kg/day in children ages 3 to <18 years with open growth plates.
PROPEL 3 successfully met the primary endpoint of change from baseline in annualized height velocity (“AHV”) at Week 52 (p<0.0001). Change from baseline in AHV was superior to placebo at Week 52 with a mean treatment difference against placebo of +2.10 cm/year; the least squares (“LS”) mean was +1.74 cm/year.
PROPEL 3 successfully met the key secondary endpoint of change from baseline in height Z-score (achondroplasia reference population) at Week 52 (p<0.0001), with an LS mean increase on the treatment arm of +0.41 SD.
Oral infigratinib was well tolerated, with no discontinuations or serious adverse events related to the drug study, 3 cases (4%) of hyperphosphatemia considered mild and transient with not a single case requiring either dose reduction or discontinuation, and no adverse events associated with inhibition of FGFR1 or 2.
Market Opportunity
We believe that achondroplasia and other FGFR-driven skeletal dysplasias represent a potentially over $5.0 billion total global market opportunity. We believe that low-dose infigratinib, if approved, would have meaningful commercial potential to demonstrate best-in-class efficacy as well as a differentiated oral route of administration preferred by many patients.
Infigratinib is administered orally as a sprinkle capsule that can be swallowed whole or the capsules can be opened with the granules administered on soft food. Despite the availability of approved injectable therapies, a substantial proportion of eligible children remain untreated, with injection burden frequently cited as the primary barrier to initiation or continuation of therapy.
If approved, we believe low-dose infigratinib could support broader uptake across both treatment-naïve patients and those currently receiving injectable therapies, particularly given its oral administration and mechanism designed to directly address FGFR3-driven disease biology.
Condition Overview and Design Criteria
Achondroplasia is the most common heritable cause of disproportionate short stature with a prevalence of greater than 55,000 in the United States and Europe. It is caused by gain-of-function variants in the gene encoding fibroblast growth factor 3 (“FGFR3”). This alteration impairs the process of endochondral skeletal ossification through inhibition of chondrocyte proliferation and differentiation. This inhibition occurs through the signal transducer and activator of transcription 1 (“STAT1”) and mitogen-activated protein kinase (“MAPK”) pathways in chondrocytes. Persons living with achondroplasia can have a variety of medical complications, functional limitations and psychosocial challenges.
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We are developing low-dose infigratinib based upon two key design principles. First, we seek to target achondroplasia at its source (FGFR3 overactivity) in order to address all manifestations of the condition, not just height. Second, we also seek to provide a tolerable oral treatment option in order to provide a reduced burden of treatment versus injection for children and their families. As an FGFR1-3 inhibitor, we believe that low-dose infigratinib has the potential to decrease downstream signaling of FGFR3 and treat both conditions at the source. Unlike C-type natriuretic (“CNP”) analogs, which only inhibit MAPK signaling, our approach is aimed at also inhibiting STAT1 signaling. We believe low-dose infigratinib is the only investigational therapy with Phase 3 results that incorporates both these design principles.
Development Status and Next Steps
Based on the positive topline results of PROPEL 3, we intend to submit an NDA to the FDA and an MAA to the EMA in the second half of 2026 for achondroplasia.
In addition, we have dosed the first participant in the PROPEL infant and toddler study (“PROPEL I&T”). PROPEL I&T is a Phase 2b, randomized, double-blind, placebo-controlled clinical trial, preceded by a single ascending dose portion and a Phase 2 open-label portion, to evaluate the safety and efficacy of oral infigratinib in infants and young children living with achondroplasia.
In addition, the open-label, long-term extension study of infigratinib in children with achondroplasia is ongoing to evaluate the long-term safety, tolerability and efficacy of infigratinib in subjects with achondroplasia. This study will allow the confirmation that changes observed during the first or second year of treatment will continue during the growth period resulting in a clinically relevant improvement in final height and a trend toward improvement of other clinically relevant parameters, such as complications associated with ACH.
Infigratinib has received Breakthrough Therapy Designation, and Rare Pediatric Disease Designation from the FDA for achondroplasia, as well as Fast Track Designation and Orphan Drug Designation for both achondroplasia and hypochondroplasia.
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Encaleret for the treatment of Autosomal Dominant Hypocalcemia Type 1
Summary
Encaleret is an investigational, oral small molecule, negative allosteric modulator of the calcium sensing receptor (“CaSR”) that we are developing for the treatment of Autosomal Dominant Hypocalcemia Type 1 (“ADH1”) and Chronic Hypoparathyroidism (“CHP”).
CALIBRATE Topline Readout
In October 2025, we reported positive data from our Phase 3 topline results for encaleret in patients with ADH1. The CALIBRATE study, our global Phase 3 registrational study of encaleret in adults with ADH1, met all prespecified primary and key secondary endpoints, demonstrating statistically significant superiority of encaleret compared to conventional therapy.
The CALIBRATE study was designed to study the efficacy and safety of encaleret in adult and adolescent ADH1 patients. The primary endpoint was defined as the proportion of participants randomized to receive encaleret achieving both serum calcium (8.3-10.7 mg/dL) and urine calcium (<300 mg/day for males and <250 mg/day for females) in the respective target ranges.
The primary endpoint—defined as the proportion of participants achieving both serum calcium and 24-hour urine calcium within their respective target ranges at Week 24—was achieved by 76% of participants administered encaleret, compared to 4% of the same participants while on conventional therapy (p<0.0001). In a key secondary analysis, 91% of participants receiving encaleret achieved intact parathyroid hormone (PTH) levels above the lower limit of the reference range at Week 24, compared to 7% on conventional therapy (p<0.0001).
Encaleret demonstrated rapid and sustained normalization of serum calcium and urine calcium, with improvements observed within days of treatment initiation and maintained through the 24-week maintenance period. Among participants who met the primary endpoint on encaleret, none required conventional therapy during the maintenance period. Encaleret was generally well tolerated, with no discontinuations related to the drug study. Among the randomized trial participants, 97% elected to join in the study’s long-term extension to further evaluate the durability of response to encaleret.
Following these results, we plan to submit an NDA to the FDA in the first half of 2026, followed by an MAA to the EMA.
Market Opportunity
We believe that ADH1 is a serious medical condition with unmet needs and represents a market with significant commercial potential. ADH1 is caused by gain-of-function variants of the CASR gene, and independent studies of general population genetic datasets estimate that there are 25,000 carriers of ADH1-causative variants in the EU and US. If approved, encaleret could be the first targeted therapy indicated for the treatment of ADH1. Additionally, if approved, we believe there are market expansion opportunities for encaleret in pediatric ADH1 and in chronic hypoparathyroidism given its profile as an orally administered therapy.
ADH1 Disease Overview and Design Criteria
ADH1 is a rare autosomal dominant genetic disease where gain of function variants in the CASR gene result in overactive CaSRs for patients. Overactive CaSRs cause dysregulation of calcium homeostasis including lower serum calcium and PTH levels as well as higher urine calcium levels. Symptoms of hypocalcemia can vary in severity, and include hypocalcemic seizures, paresthesia, tetany, and muscle cramps. Patients have a long-term risk of nephrolithiasis, nephrocalcinosis, and chronic kidney disease from elevated urine calcium levels.
ADH1 Development Status and Next Steps
We plan to dose the first participant in the registrational Phase 2/3 study of encaleret in pediatric ADH1 in the first quarter of 2026.
Our development activities are focused on expanding the potential populations that would benefit from encaleret. Some ADH1 patients start experiencing symptoms soon after birth and many end up being diagnosed with a hypocalcemia-related disorder earlier in life (median age of diagnosis is 4 years old). There is a median delay of approximately two decades before patients receive a genetically confirmed diagnosis. To expand treatment options for younger patients, we plan to dose the first participant in a registrational Phase 2/3 study investigating encaleret in pediatric ADH1 in the first quarter of 2026.
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Encaleret has been granted orphan drug and fast track designations by the FDA for the treatment of autosomal dominant hypocalcemia. Encaleret has also been granted orphan designation by the European Commission and by the Japan Ministry of Health, Labor and Welfare as a treatment for hypoparathyroidism and ADH1.
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BBP-418 for the treatment of Limb Girdle Muscular Dystrophy Type 2I/R9
Summary
BBP-418 is an investigational, orally administered, small molecule therapy that we are developing for the treatment of LGMD2I, also known as LGMDR9 FKRP-related.
FORTIFY Interim Topline Readout
In October 2025, we reported positive topline results from the planned interim analysis of FORTIFY, a global, randomized, double-blind, placebo-controlled Phase 3 study evaluating BBP-418 in individuals with LGMD2I/R9. The FORTIFY interim analysis met all primary and key secondary endpoints, demonstrating statistically significant and clinically meaningful improvements across biomarker and functional measures, with a favorable safety profile.
Based on the FORTIFY interim analysis results and prior regulatory interactions, we are engaging with the FDA as we plan for submission of an NDA in the first half of 2026. If approved, BBP-418 may be eligible for a Priority Review Voucher under the Rare Pediatric Disease program. The FORTIFY study remains ongoing, with additional data collection and longer-term follow-up continuing.
BBP-418 has received Orphan Drug Designation, Fast Track Designation, and Rare Pediatric Disease Designation from the FDA, as well as Orphan Drug Designation from the EMA.
Market Opportunity
LGMD2I/R9 affects an estimated approximately 7,000 individuals across the United States and Europe, including patients with LGMD2I/R9 and other potentially addressable dystroglycanopathies. The disease is underdiagnosed, and progression often leads to loss of ambulation, respiratory compromise, and cardiomyopathy.
If approved, BBP-418 has the potential to become the first disease-modifying therapy for LGMD2I/R9. We plan to commercialize BBP-418 globally and are leveraging BridgeBio’s established rare disease commercial infrastructure, including launch experience, market access capabilities, and patient support services, to prepare for a potential launch.
Disease Overview and Design Criteria
LGMD2I/R9 is an inherited neuromuscular disorder characterized by lower-limb weakness and loss of ambulation, and possible pulmonary and cardiac dysfunction. BBP-418 has a potentially-addressable patient population of 7,000, including both LGMD2I/R9 and other potentially-addressable dystroglycanopathies, in the United States and Europe. Currently, there is no disease-modifying treatment available. Standard of care is supportive care to alleviate end organ dysfunction.
The rationale for developing BBP-418 as a potential treatment for LGMD2I/R9 is based on our understanding of the disease mechanism. In healthy tissue, a properly functioning Fukutin-Related Protein (“FKRP”) glycosylates alpha-dystroglycan (“αDG”). This glycosylation helps to stabilize muscle cells by binding extracellular ligands. In LGMD2I/R9, mutated FKRP does not function properly and results in dysfunctional, hypo-glycosylated αDG in muscle cells, limiting αDG’s ability to function as a “shock absorber” for muscle fibers and increasing cellular susceptibility to damage.
BBP-418 is designed to target the disease mechanism of LGMD2I/R9 by supplying supra-physiological levels of BBP-418 upstream to drive residual activity of the mutant FKRP enzyme and increase glycosylated αDG levels.
Development Status and Next Steps
BBP-418 is currently being evaluated in the ongoing FORTIFY Phase 3 study. Based on the positive interim analysis results and our interactions with the FDA to date, we intend to submit an NDA to the FDA in the first half of 2026.
The key findings from the planned interim analysis at 12 months included:
• A statistically significant near doubling (1.8-fold increase) in glycosylated αDG from baseline at 3 months compared to approximately no change in the placebo group ( p <0.0001), with improvements sustained through 12 months ( p <0.0001)
• An 82% mean reduction from baseline in serum creatine kinase (CK), a marker of muscle damage, which was statistically significant compared to placebo ( p <0.0001)
• Statistically significant improvements in ambulatory function, as measured by the 100-meter timed test ( p <0.0001), and pulmonary function, as measured by forced vital capacity (FVC) ( p =0.0071)
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• Statistically significant and clinically meaningful 2.6 point benefit on North Star Assessment (NSAD) for limb-girdle type muscular dystrophies compared to placebo (nominal p=0.0001)
• Consistent treatment effects across planned subgroups, including genotype (individuals with the L276I homozygous genotype vs. those with other FKRP variants), age group (pediatric vs. adult), and pulmonary function (baseline FVC ≥80% vs. baseline FVC 40-80%)
• Well-tolerated safety profile, with no new or unexpected safety findings and no treatment-related serious adverse events observed
The approval, timing, and scope of any potential regulatory submission will depend on further regulatory review, the completeness of the clinical data package, and discussions with regulatory authorities. If approved, we expect to leverage our commercial infrastructure to support the potential launch of BBP-418 globally, subject to all regulatory outcomes.
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Development Portfolio – Phase 2 Pipeline Candidates
Our Phase 2 development portfolio includes expansion indications of our Phase 3 programs with commercial potential, as well as standalone programs that have demonstrated clinical proof-of-concept. These programs represent the next set of potential product candidates emerging from our portfolio-based development model.
Encaleret for the treatment of Chronic Hypoparathyroidism (“CHP”)
In September 2025, we completed a Phase 2 proof-of-concept study investigating the PTH-independent effects of encaleret on renal calcium handling in patients with post-surgical hypoparathyroidism. In collaboration with clinical researchers at the National Institutes of Health, the study enrolled 10 patients.
Encaleret treatment resulted in PTH-independent normalization of blood and urine calcium in 80% of participants to be within the normal reference range within 5 days of encaleret initiation compared to 0% of participants on conventional therapy at baseline. Encaleret was well tolerated with no serious adverse events reported over the study period.
Based on these positive results, we completed an End of Phase 2 interaction with the FDA, and we plan to initiate a registrational Phase 3 study in adults with CHP in the summer of 2026.
CHP represents a larger potential patient population with an estimated 200,000 patients in the US and Europe. Existing clinical data support the continued evaluation of encaleret as an orally administered treatment option for patients with CHP.
Infigratinib for Hypochondroplasia
We are developing low-dose infigratinib for hypochondroplasia, a related FGFR3-driven skeletal dysplasia characterized by disproportionate short stature and variable skeletal and neurologic manifestations. There are currently no FDA-approved pharmacologic therapies for hypochondroplasia.
We believe that the total global market opportunity for hypochondroplasia will approach that of the achondroplasia market, driven by growing awareness of the condition due to ongoing clinical trials in the condition. We believe that low-dose infigratinib, if approved, would have meaningful commercial potential as a differentiated oral route of administration preferred by many patients.
We are enrolling participants in ACCEL, a prospective natural history study in children with hypochondroplasia. This trial is designed to establish baseline growth parameters, including AHV, in children with hypochondroplasia. ACCEL is intended to support enrollment into ACCEL 2/3, a planned Phase 2/3 interventional program consisting of an initial open-label phase followed by a randomized, placebo-controlled study evaluating the safety and efficacy of infigratinib.
Enrollment in the Phase 2 portion of ACCEL 2/3 has been completed, with proof-of-concept results expected in the second half of 2026. Based on the positive PROPEL 3 study topline data for oral infigratinib for achondroplasia, we plan to accelerate the development of oral infigratinib in hypochondroplasia, and are enrolling the observational run-in for the Phase 3 trial.
BBP-812 for the treatment of Canavan disease
Canavan disease (“CD”) is an ultra-rare neurodegenerative disease with approximately 1,000 patients across the US and EU. CD is usually fatal within the first two decades of life, and more than 25% of patients die by the age of 10 years. Children with CD exhibit global and severe cognitive, motor, and language impairment, missing or regressing on most developmental milestones. There are currently no therapies approved for the treatment of CD.
If approved, BBP-812 has the potential to become the first disease-modifying therapy for CD. BBP-812 has previously received Orphan Drug, Fast Track, Regenerative Medicine Advanced Therapy, and Rare Pediatric Disease Designations from the FDA and Orphan Drug Designation from the EMA. Consistent with the Rare Pediatric Designation from the FDA, if BBP-812 is approved, we may qualify for a Priority Review Voucher.
We are conducting a Phase 1/2 study (CANaspire) for BBP-812 for Canavan disease. The program is designed to provide a first disease-modifying therapy by targeting the condition at its source and supporting accelerated approval through a single registrational study using a biomarker. It also leverages an established IV AAV9 safety profile while avoiding invasive neurosurgery through a less burdensome intravenous treatment approach.
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Development Portfolio - Early-Stage and Clinical Development Interests
Our early-stage and clinical development activities and interests include a combination of internally developed programs and minority ownership interests in independent companies that were spun out of BridgeBio in 2024.
Evanesco (Depleter)
BridgeBio has initiated a next-generation depleter program for the potential treatment of ATTR-CM. While TTR stabilizers and gene-silencing therapies reduce the formation of new amyloid, many patients are diagnosed after meaningful amyloid deposition has already occurred. A therapeutic approach capable of removing existing amyloid deposits could be used in combination with current therapies and may expand the addressable patient population in ATTR-CM. If successfully developed, this program could complement BridgeBio’s existing ATTR-CM portfolio and support a more comprehensive treatment regimen addressing both prevention of new deposits and clearance of existing amyloid burden.
The depleter is a monoclonal antibody designed to selectively bind misfolded, amyloidogenic TTR and promote clearance through macrophage-mediated phagocytosis. The program incorporates several design features intended to enhance differentiation, including preferential binding to amyloid fibrils over native TTR, Fcγ receptor enhancement to support immune-mediated clearance, pH-dependent antigen release to facilitate antibody recycling, and FcRn-mediated half-life extension to enable less frequent dosing.
The ATTR-CM depleter program is currently in preclinical development. BridgeBio plans to advance the program into the clinic in 2027–2028, subject to successful completion of IND-enabling studies and regulatory review.
GondolaBio
GondolaBio, LLC (“GondolaBio”) is an independent company focused on the discovery and development of therapies for rare genetic diseases. GondolaBio operates with its own management team and development strategy and maintains a diversified pipeline of early and mid-stage programs across multiple therapeutic areas and modalities, including hematologic, neurologic, renal, hepatic, and dermatologic genetic disorders. As of December 31, 2025, BridgeBio held a 27.5% ownership interest in GondolaBio, which is subject to dilution as additional capital is contributed to GondolaBio through equity investments by third-party investors.
A key program within the pipeline is PORT-77, a small-molecule ABCG2 inhibitor in Phase 2a development for erythropoietic protoporphyria (“EPP”), a rare genetic disease with significant unmet medical need, for which positive proof-of-concept clinical data have been reported. Based on clinical data to date, GondolaBio intends to initiate a Phase 2b/3 clinical trial in 2026, pending regulatory feedback.
BridgeBio Oncology Therapeutics, Inc.
BridgeBio Oncology Therapeutics (“BBOT”) is a clinical-stage biopharmaceutical company advancing a next-generation pipeline of novel small molecule therapeutics targeting RAS and Phosphoinositide 3-kinase malignancies. See Note 6 to our consolidated financial statements appearing elsewhere in this Annual Report on Form 10-K for a description of transactions involving BBOT and TheRas, Inc., our former majority-owned subsidiary, which was deconsolidated in April 2024 and completed a business combination transaction with BBOT’s predecessor, Helix Acquisition Corp. II, in August 2025.
On August 11, 2025, BridgeBio Oncology Therapeutics, Inc. became listed on Nasdaq under the ticker symbol “BBOT.” As of December 31, 2025, BridgeBio held an 18.2% ownership interest in BBOT.
BBOT’s pipeline includes multiple clinical-stage and late preclinical programs, including direct KRAS inhibitors and other genetically targeted oncology assets. Several of BBOT’s programs have advanced into clinical trials and have reported early clinical activity, supporting the continued progression of its pipeline. BBOT’s programs span multiple tumor types and are designed to address resistance mechanisms and limitations of earlier-generation targeted therapies.
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Competition
The biopharmaceutical industry is highly competitive, and we face competition from established pharmaceutical and biotechnology companies, as well as academic research institutions, developing therapies for similar indications. Some competitors may have greater financial, regulatory, manufacturing, and commercial resources.
Competition is based on factors including clinical performance, regulatory approval, intellectual property protection, pricing and reimbursement, and commercial execution. There can be no assurance that our products or product candidates, if approved, will achieve market acceptance relative to competing therapies.
Material Commercial Products
ATTRUBY
Attruby/Beyonttra (acoramidis) for the treatment of adults with ATTR-CM competes with Vyndaqel / Vyndamax (tafamidis meglumine / tafamidis), which is a commercial product marketed by Pfizer, Inc. and approved in certain territories, including the United States, the European Union, and Japan as a treatment for ATTR-CM. In addition, Alnylam Pharmaceuticals, Inc.’s vutrisiran received regulatory approvals in 2025 for the treatment of ATTR-CM in multiple jurisdictions globally, and Attruby/Beyonttra competes with vutrisiran in markets where it is approved. Additionally, there are a number of RNAi, antisense oligonucleotide, antibody, and gene editing product candidates that are currently in development as potential treatments for ATTR-CM.
Phase 3 Registrational programs
Infigratinib for Achondroplasia
Low-dose infigratinib is an orally administered selective FGFR1-3 inhibitor in late-stage clinical development for achondroplasia. Other companies are developing therapies for achondroplasia, including Ascendis Pharma A/S (TransCon CNP), Tyra Biosciences, Inc. (TYRA-300), and Ribomic (RBM-007), each of which targets pathways associated with FGFR3 signaling through different mechanisms.
If approved, infigratinib would compete with BioMarin Pharmaceutical Inc.’s Voxzogo® (vosoritide), which is approved in multiple territories, including the United States, the European Union, Japan, Brazil, and Australia, as well as with other investigational therapies that may receive regulatory approval in the future. We are aware of the following companies pursuing clinical development of product candidates for the treatment of achondroplasia: Ascendis Pharma A/S (TransCon CNP), Tyra Biosciences Inc. (TYRA-300), and Ribomic (RBM-007).
BBP-418 – Limb-Girdle Muscular Dystrophy Type 2I/R9 (LGMD2I/R9)
To our knowledge, there are currently no approved therapies indicated for LGMD2I/R9.
Encaleret – Autosomal Dominant Hypocalcemia Type 1 (ADH1)
There are currently no approved disease-modifying therapies specifically indicated for ADH1, and conventional therapy currently consists of oral calcium and/or activated vitamin D supplementation. Encaleret, if approved, may compete with conventional therapy and other investigational agents evaluated to normalize blood and urine calcium in ADH1.
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Intellectual Property
Overview
We strive to protect the proprietary technology that we believe is important to our business through a variety of methods, including seeking and maintaining patents and patent applications intended to cover our product candidates and compositions, their methods of use and processes for their manufacture, our platform technologies and any other aspects of inventions that are commercially important to the development of our business. We seek to obtain domestic and international patent protection and, in addition to filing and prosecuting patent applications in the United States, we may file counterpart patent applications in additional countries where we believe such foreign filing is likely to be beneficial, including Australia, Canada, Europe, China, Japan, and Mexico. We have entered into various license agreements to obtain the rights to use certain patents for the development and commercialization of our product candidates, as discussed further in the section titled, “ Our Material Agreements .” We also rely on trade secrets to protect aspects of our business that are not amenable to, or that we do not consider appropriate for, patent protection.
Our success will depend on our ability to obtain and maintain patent and other proprietary rights protecting our commercially important technology, inventions and know-how related to our business, defend and enforce our current and future issued patents, if any, preserve the confidentiality of our trade secrets and operate without infringing the valid and enforceable patents and proprietary rights of third parties. We continually assess and refine our intellectual property strategy in order to best fortify our position, and file additional patent applications when our intellectual property strategy warrants such filings. We also rely on know-how, continuing technological innovation, and potential in-licensing opportunities to develop and maintain our intellectual property portfolio. We seek to obtain domestic and international patent protection, and endeavor to promptly file patent applications for new commercially valuable inventions.
The patent positions of biopharmaceutical companies like us are generally uncertain and involve complex legal, scientific, and factual questions. In addition, the coverage claimed in a patent application can be significantly reduced before the patent is issued, and patent scope can be reinterpreted by the courts after issuance. Moreover, many jurisdictions permit third parties to challenge issued patents in administrative proceedings, which may result in further narrowing or even cancellation of patent claims. We cannot predict whether the patent applications we are currently pursuing will issue as patents in any particular jurisdiction or whether the claims of any patents, if issued, will provide sufficient protection from competitors.
Because patent applications in the United States and certain other jurisdictions are maintained in secrecy for 18 months or potentially even longer, and since publication of discoveries in the scientific or patent literature often lags behind actual discoveries, we cannot be certain of the priority of inventions covered by pending patent applications. Moreover, we may have to participate in interference proceedings or derivation proceedings declared by the United States Patent and Trademark Office (“USPTO”) to determine priority of invention.
As of February 6, 2026, our intellectual property portfolio is composed of over 200 issued patents and over 300 patent applications that we license from academic and research institutions and other third parties or that we own or co-own, including through our subsidiaries. These patents and patent applications generally provide us with the rights to develop our product candidates in the United States and worldwide. Our intellectual property portfolios for each of the programs that we consider to be our core value drivers are further described below.
For our subsidiary, QED Therapeutics, Inc. (“QED”), we license rights from Novartis under two issued U.S. patents, and related pending and issued foreign patents and patent applications in Australia, Canada, China, Europe, Japan and Mexico, as well as in other countries in Asia and in South America, that are directed to compositions of matter of infigratinib. The foreign patents and patent applications, if issued, are expected to expire between 2025 and 2030. The issued U.S. patents are expected to expire between 2028 and 2029, which takes into account patent term adjustments granted by the USPTO as well as a terminal disclaimer of one issued patent to another U.S. patent. Upon the initial approval of infigratinib, QED applied for 1,516 days of patent term extension (“PTE”), for the U.S. patent covering the infigratinib compound; assuming grant of the PTE application, the term of this patent may be extended from August 25, 2029, to October 19, 2033.
We also license rights from Inserm Transfert ESA and Assistance Publique-Hôpitaux de Paris under two issued U.S. patents and one pending U.S. patent application, and one granted patent in Europe, that are directed to methods of treating skeletal dysplasias using infigratinib. The issued U.S. patents, granted patent in Europe, and the pending patent application, if issued, are expected to expire in 2032.
In addition, QED owns two pending U.S. patent applications, and related pending foreign patent applications in Australia, Canada, China, Europe, Japan and Mexico, as well as in other countries, that are directed to methods of treating skeletal disorders using infigratinib. If any patents issue from these patent applications, such patents would be expected to expire between 2041 and 2044.
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For our subsidiary Eidos Therapeutics, Inc., we license rights from the Board of Trustees of the Leland Stanford Junior University, or Stanford, under ten issued U.S. patents, two pending U.S. patent applications, one issued European patent, and one issued Japanese patent with claims directed to composition of matter and methods of use relating to acoramidis. These patents are expected to expire in 2031 or 2033, not including any potential patent term extension. Upon approval of acoramidis, patent term extension applications were timely filed for multiple U.S. patents licensed from Stanford.
In addition, we own eight issued U.S. patents, five pending U.S. patent applications, one Patent Cooperation Treaty (“PCT”) patent application, and over 60 related foreign issued patents and patent applications in various jurisdictions, including Australia, Canada, Europe, China, Japan, and Mexico, with claims directed to salt and solid forms, methods of manufacturing, dosing methods, and/or formulations relating to acoramidis. The issued U.S. and foreign patents are expected to expire in 2038 or 2039. The pending U.S. and foreign patent applications, if issued, are also expected to expire between 2038 and 2044.
For our subsidiary, Calcilytix, Inc., we license rights from Japan Tobacco Company under one issued U.S. patent and two foreign patents in Europe and Japan that are directed to compositions of matter of encaleret. These patents expired in 2024 and 2025. In addition, Calcilytix owns or co-owns one issued U.S. patent, three pending U.S. patent applications, and over thirty related foreign patent applications pending in various jurisdictions, including Australia, Canada, Europe, China, Japan, and Mexico with claims to formulations, dosing methods, and patient selection methods relating to encaleret. The pending U.S. and foreign patent applications, if issued, are expected to expire between 2041 and 2044, not including any potential patent term extension.
For our subsidiary, ML Bio Solutions, Inc. (“ML Bio”), we license rights from the Charlotte-Mecklenburg Hospital Authority d/b/a Atrium Health under eight issued U.S. patents, two pending U.S. patent applications, and over thirty related foreign patent applications pending in various jurisdictions, including Australia, Canada, Europe, China, Japan, and Mexico with claims to methods of treatment, dosing methods, and compositions relating to BBP-418. The issued U.S. patents are expected to expire in 2037 or 2040, not including any potential patent term extension. The pending U.S. and foreign patent applications, if issued, are expected to expire between 2037 and 2041, not including any potential patent term extension. In addition, ML Bio owns one pending U.S. patent applications relating to assays. The pending U.S. patent application, if issued, is expected to expire in 2044.
Our Material Agreements
Acoramidis (Attruby/Beyonttra)
License Agreement with Bayer
On March 1, 2024, certain subsidiaries of the Company, including Eidos, BridgeBio International GmbH and BridgeBio Europe B.V. (collectively, the “Seller Parties”), entered into an exclusive license agreement (the “Bayer License Agreement”) with Bayer Consumer Care AG, a wholly-owned subsidiary of Bayer AG (“Bayer”), to develop and commercialize acoramidis as a treatment for transthyretin amyloidosis in the EU and all member and extension states of the European Patent Organization (the “Licensed Territory”).
Under the terms of the Bayer License Agreement, the Seller Parties granted Bayer an exclusive license on March 26, 2024 to certain of the Seller Parties’ intellectual property rights to develop, manufacture and commercialize acoramidis (previously known as AG10) in the Licensed Territory. In consideration for the license grant, the Seller Parties are entitled to receive an upfront payment of $135.0 million, which was received in full in May 2024, and will be eligible to receive up to $150.0 million in regulatory and sales milestone payments through 2026 (of which a regulatory milestone of $75.0 million was achieved in February 2025 upon EC approval of acoramidis under the brand name Beyonttra and received in April 2025), and additional payments up to $450.0 million subject to the achievement of certain sales milestones. In addition, the Seller Parties are entitled to receive royalties according to a tiered structure starting in the low-thirties percent on net sales by Bayer of acoramidis in the Licensed Territory, subject to reduction under certain circumstances as provided in the Bayer License Agreement.
Unless earlier terminated, the Bayer License Agreement will expire at the end of the royalty term for a licensed product, provided that the licenses granted to Bayer for such licensed product survive such expiration on a non-exclusive basis. Either party may terminate the Bayer License Agreement in the event of a material breach or insolvency of the other party or in the event merger control proceedings are started and clearances are not obtained. Additionally, Bayer may terminate the Bayer License Agreement for convenience upon at least 270 days’ prior written notice, and Eidos may terminate the agreement in the event Bayer ceases exploitation of Beyonttra under certain circumstances or challenges the validity or enforceability of Eidos’ patent rights.
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In June 2024, BridgeBio Europe B.V. (“BridgeBio B.V.”) entered into a commercial supply agreement with Bayer (“Bayer Commercial Supply Agreement”) with an initial 30-month term ending in December 2026, for which BridgeBio B.V. will manufacture and supply to Bayer the commercial product ordered by Bayer solely for use in the commercialization in the Licensed Territory under the Bayer License Agreement. In March 2025, BridgeBio B.V. and Bayer entered into an agreement (“Bayer API Supply Agreement”) for the manufacture and supply by BridgeBio B.V. to Bayer of API solely for the use in the commercialization in the Licensed Territory. The Bayer API Supply Agreement has an initial term ending in December 2026, which is consistent with the Bayer Commercial Supply Agreement. The Bayer Commercial Supply Agreement and the Bayer API Supply Agreement are collectively referred to as the “Bayer Supply Agreements.” Under the Bayer Supply Agreements, Bayer shall pay to BridgeBio B.V. a per unit price equal to the applicable fully burdened manufacturing cost per unit of the product.
Refer to Footnote 11 of the “ Notes to Consolidated Financial Statements ” for further details.
License Agreement with Alexion
In September 2019, through our subsidiary Eidos, we entered into a license agreement (the “Eidos-Alexion License Agreement”), with Alexion Pharma International Operations Limited Company, a subsidiary of Alexion Pharmaceuticals, Inc. (together, “Alexion”), to develop and commercialize Beyonttra in Japan. Under the terms of the Eidos-Alexion License Agreement, Eidos granted Alexion an exclusive license to certain of our intellectual property rights to develop, manufacture and commercialize Beyonttra in Japan. In consideration for the license grant, Eidos received an upfront payment of $25.0 million and became eligible to receive a regulatory milestone payment of $30.0 million. Following pricing approval from the National Health Insurance in Japan in May 2025, the regulatory milestone was fully achieved and recognized as license and services revenue, and in June 2025, Eidos received the $30.0 million regulatory milestone payment. Under the Eidos-Alexion License Agreement, Eidos is eligible to receive royalties in the low-teens based on net sales of acoramidis in Japan. The royalty rate is subject to reduction if Alexion is required to obtain intellectual property rights from third parties to develop, manufacture or commercialize Beyonttra in Japan, or upon the introduction of generic competition into the market.
Furthermore, in October 2024, Alexion notified Eidos that it intends to initiate the ACT-EARLY clinical trial in Japan under the Eidos-Alexion License Agreement for an upfront payment received by Eidos of $3.0 million.
Refer to Footnote 11 of the “ Notes to Consolidated Financial Statements ” for further details.
License Agreement with the Board of Trustees of the Leland Stanford Junior University
In April 2016, through Eidos, we entered into an exclusive license agreement with Stanford for rights relating to novel transthyretin aggregation inhibitors. Under our agreement, Stanford has granted us an exclusive worldwide license to make, use and sell products that are covered by the licensed patent rights. This license grant expires when the last licensed patent expires. The patent rights exclusively licensed to us under the license are described in more detail above under the heading “Intellectual property— Eidos Therapeutics, Inc.” Stanford and Eidos agree in good faith to meet and discuss performance of development milestones which are specified in amendments to the license agreement.
Stanford retains the right, on behalf of itself and all other non-profit academic research institutions, to practice under the patent rights for any non-profit purpose, including sponsored research and collaborations. We may grant sublicenses to third parties so long as we are actively pursuing the development or commercialization of products covered by the patent rights. We may also be required to sublicense our rights under the agreement at Stanford’s request under certain conditions, including if we are unwilling or unable to serve a potential market or territory and there is a third party willing to be a sublicensee in such market or territory.
We are obligated to pay to Stanford a yearly license maintenance fee during the term of the agreement, but we may offset the maintenance fee against earned royalty payments due on net sales occurring in that year. Stanford is entitled to receive a royalty as a percentage of net sales of licensed products, in the low single digits. We have agreed to pay Stanford a percentage of non-royalty revenue we receive from our sublicensees, with the amount owed decreasing annually for three years based on when we enter into the applicable sublicense agreement. In addition, we are obligated to pay Stanford up to approximately $1.0 million upon the achievement of specific intellectual property, clinical and regulatory milestone events. In the event of a change of control transaction with respect to Eidos, we are obligated to pay Stanford a change of control fee of $250,000 in connection with the assignment of the license agreement to the acquirer of Eidos.
Under the license agreement with Stanford, we are obligated to use commercially reasonable efforts to develop, manufacture, and commercialize at least one licensed product; to develop markets for such licensed products; and to meet certain development milestones as agreed upon between us and Stanford.
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Subject to the expiration of the license grant described above, the agreement does not have a specified term. We may terminate the agreement by providing prior written notice to Stanford, and Stanford has the right to terminate the agreement if we fail to achieve certain milestones or make payments under the agreement or are not actively pursuing development of a licensed product, or if we otherwise materially breach the agreement and fail to cure such breach within a specified grace period.
Refer to Footnote 12 of the “ Notes to Consolidated Financial Statements ” for further details.
Infigratinib
Kyowa Kirin Exclusive License
On February 7, 2024, the Company’s subsidiary, QED, and Kyowa Kirin Co., Ltd (“Kyowa Kirin” or “KKC”) entered into a license and collaboration agreement pursuant to which QED granted Kyowa Kirin an exclusive license to develop, manufacture, and commercialize infigratinib for achondroplasia, hypochondroplasia, and other skeletal dysplasias in Japan, in accordance with the terms therein (the “KKC License Agreement”). In consideration for the license grant, QED is entitled to receive an upfront payment of $100.0 million, which was received in full in June 2024, and will be eligible to receive development and sales milestone payments up to $81.4 million. In addition, QED is entitled to receive royalties up to the mid-twenties percent on net sales of infigratinib in Japan.
Unless earlier terminated, the KKC License Agreement will expire at the end of the royalty term for a licensed product, provided that the licenses granted to Kyowa Kirin for such licensed product survive such expiration on a non-exclusive basis. Either party may terminate the KKC License Agreement in the event of a material breach or insolvency of the other party. Additionally, Kyowa Kirin may terminate the KKC License Agreement for convenience upon at least 180 days’ prior written notice, and QED may terminate the KKC License Agreement in the event Kyowa Kirin ceases exploitation of infigratinib under certain circumstances or challenges the validity or enforceability of Kyowa Kirin’s patent rights.
Refer to Footnote 11 of the “ Notes to Consolidated Financial Statements ” for further details.
License Agreement with Novartis International Pharmaceutical Ltd.
In January 2018, through our subsidiary QED, we entered into a license agreement with Novartis International Pharmaceutical Ltd. (“Novartis”), for certain intellectual property rights, including patents and know-how, related to infigratinib for the treatment of patients with FGFR-driven diseases, including achondroplasia and hypochondroplasia. We refer to this agreement as the Novartis License.
Pursuant to the Novartis License, we obtained a license to research, develop, make, have made, use, import, offer for sale, sell, have sold and otherwise commercialize infigratinib, as well as therapeutic products incorporating infigratinib that would, but for the license grant, infringe Novartis’ license patent rights, or that were developed using or that incorporate or embody Novartis’ licensed know-how, in all fields of use worldwide. The license grant to us includes the right to sublicense through multiple tiers. We also have certain rights to intellectual property licensed to Novartis’ affiliate under a materials transfer agreement with a third party.
The Novartis License is subject to Novartis’ existing obligations to supply a third party with infigratinib to support the third party’s clinical trials, and we have an ongoing obligation to inform Novartis of our or our sublicensees’ intent to seek regulatory approval for and commercialize infigratinib for various indications, with potential reversionary rights to Novartis in the event of a subsequent decision not to seek regulatory approval and commercialization, or a determination by Novartis that we have failed to sufficiently pursue regulatory approval and commercialization, for Novartis to grant such third party limited rights to develop and commercialize infigratinib.
Under the terms of the Novartis License, we made a one-time payment of $15.0 million to Novartis and agreed to issue shares of Series A preferred stock of QED valued at approximately $1.7 million in the aggregate to Novartis. In addition, we are obligated to make contingent milestone payments totaling $60.0 million upon achievement of certain regulatory milestones. We are also obligated to make contingent milestone payments totaling $35.0 million upon achievement of certain sales milestones for therapeutic products incorporating infigratinib. QED also agreed to pay Novartis tiered low double-digit royalties on net sales of therapeutic products incorporating infigratinib. Following the FDA’s approval of TRUSELTIQ TM in May 2021, we paid a one-time regulatory milestone payment to Novartis of $20.0 million.
Under the Novartis License, we are required to use commercially reasonable efforts to develop infigratinib, and to obtain regulatory approval for and commercialize infigratinib in the United States and the European Union.
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We may terminate the Novartis License in its entirety or on a product-by-product or country-by-country basis at any time with 60 days’ prior written notice to Novartis. Novartis may terminate if QED ceases to function as a going concern, is the subject of certain bankruptcy or similar proceedings, or otherwise winds down or discontinues its business. Either party may terminate for material breach that is not cured by the other party within a specified time period of receiving notice of such material breach. Otherwise, the Novartis License terminates on a product-by-product and country-by-country basis on the latest of the expiration of licensed patent rights, the expiration of regulatory exclusivity, or the tenth anniversary of the first commercial sale in such country.
Corporate
Royalty Interest Purchase and Sale Agreement
On June 27, 2025 (the “Closing Date”), we and our subsidiary, Eidos Therapeutics, Inc. (“Eidos”), entered into a Royalty Interest Purchase and Sale Agreement (the “Royalty Purchase Agreement”) with Acoramidis Royalty SPV, LP (“ARS”), an affiliate of HealthCare Royalty Management, LLC (“HCRx”), as a purchaser and the purchaser representative (in such capacity, the “Purchaser Representative”), and LSI Financing Fund, LP, an affiliate of Blue Owl Capital Corporation, as a purchaser (together with ARS as a purchaser and any future permitted assignees of a purchaser, the “Royalty Agreement Purchasers”). Subsequent to the Closing Date, on July 30, 2025, KKR & Co. Inc., a beneficial holder of our common equity and a related party, acquired a majority ownership interest in HCRx. Accordingly, HCRx became our related party following KKR & Co. Inc.’s acquisition of HCRx. Pursuant to the Royalty Purchase Agreement, Eidos sold to the Royalty Agreement Purchasers certain of Eidos’ right to receive certain royalty payments (“Purchased Royalty Payment”) on net sales of certain products containing acoramidis (the “Licensed Products”) made in the EU and all member and extension states of the European Patent Organization (the “Licensed Territory”). As consideration for the sale of the Purchased Royalty Payment, the Royalty Agreement Purchasers agreed to pay Eidos $300.0 million in cash (the “Purchase Price”), which was funded in full on the Closing Date. The Royalty Agreement Purchasers’ rights to the Purchased Royalty Payment are subject to (a) an annual cap equal to 60% of all royalty payments on the first $500.0 million of annual net sales of Licensed Products in the Licensed Territory and (b) an initial hard cap equal to 145% of the Purchase Price. We recognized net cash proceeds of $297.0 million in June 2025, after deducting debt issuance costs of $3.0 million.
Refer to Footnote 10 of the “ Notes to Consolidated Financial Statements ” for further details.
2031 Notes
On February 28, 2025, we issued an aggregate of $575.0 million principal amount of our 2031 Notes pursuant to an Indenture dated February 28, 2025 (the “2031 Notes Indenture”), between us and U.S. Bank Trust Company, National Association, as trustee (the “2031 Notes Trustee”), in a private offering to qualified institutional buyers (the “2025 Note Offering”) pursuant to Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”). The 2031 Notes issued in the 2025 Note Offering include $75.0 million aggregate principal amount of 2031 Notes sold to the initial purchasers of the 2031 Notes (the “2031 Notes Initial Purchasers”) pursuant to the exercise in full of the 2031 Notes Initial Purchasers’ option to purchase additional 2031 Notes.
The 2031 Notes are senior, unsecured obligations of BridgeBio and will accrue interest payable semiannually in arrears on March 1 and September 1 of each year, beginning on September 1, 2025, at a rate of 1.75% per year. The 2031 Notes will mature on March 1, 2031, unless earlier converted, redeemed or repurchased. The 2031 Notes are convertible into cash, shares of BridgeBio’s common stock or a combination of cash and shares of BridgeBio’s common stock, at our election.
We received net proceeds from the 2025 Note Offering of approximately $563.0 million, after deducting the 2031 Notes Initial Purchasers’ discount and offering costs. We used approximately $48.3 million of the net proceeds from the 2025 Note Offering to pay for the repurchase of shares of BridgeBio’s common stock as further described in Footnote 9 of the “ Notes to Consolidated Financial Statements ” and used a portion of the net proceeds from the 2025 Note Offering to repay all outstanding borrowings under, and terminate, the Financing Agreement, as defined in Footnote 9 of the “ Notes to Consolidated Financial Statements ”, and pay any fees related thereto.
Subsequent Event - 2033 Notes, net
On January 21, 2026, we issued an aggregate of $632.5 million principal amount of our 2033 Notes. Refer to Footnote 19 of the “ Notes to Consolidated Financial Statements ” for further details.
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Financing Agreement
On January 17, 2024, we entered into a Financing Agreement (the “Financing Agreement”) with certain of our subsidiaries party thereto as guarantors, the lenders party thereto (the “Lenders”) and Blue Owl Capital Corporation, as administrative agent for the Lenders (the “Administrative Agent”), which was amended on February 12, 2024 and June 20, 2024 (the Financing Agreement, as amended by the second amendment, the “Amended Financing Agreement”). Pursuant to the terms and conditions of the Amended Financing Agreement, the Lenders have agreed to extend a senior secured credit facility to us in an aggregate principal amount of up to $750.0 million comprised of (i) an initial term loan in an aggregate principal amount of $450.0 million (the “Initial Term Loan”) and (ii) one or more incremental term loans in an aggregate amount not to exceed $300.0 million (collectively, the “Incremental Term Loan,” and together with the Initial Term Loan, collectively, the “Term Loans”), subject to the satisfaction of certain terms and conditions set forth in the Amended Financing Agreement. The Initial Term Loan was funded on January 17, 2024. Incremental Term Loans are available at the Lenders’ and our mutual consent from time to time after January 17, 2024. On February 28, 2025, the Company fully repaid the Amended Financing Agreement for $467.0 million, which consisted of $450.0 million for the outstanding principal, $9.0 million for the prepayment fee, and $8.0 million in accrued interest using the proceeds from the 2031 Notes and recognized a loss on extinguishment of debt of $21.2 million.
Refer to Footnote 9 of the “ Notes to Consolidated Financial Statements ” for further details.
Funding Agreement
On January 17, 2024, we and our subsidiaries entered into a Funding Agreement with LSI Financing 1 Designated Activity Company and CPPIB Credit Europe S.à r.l. together, the (“Purchasers”). Pursuant to the Funding Agreement, the Purchasers agreed to pay to the Company $500.0 million (net of certain transaction expenses) upon the first FDA approval of acoramidis, subject to certain conditions relating to the FDA approval and other customary conditions (such date of payment, “Funding Date”). In return, we granted the Purchasers the right to receive payments (the “Royalty Interest Payments”) equal to 5% of the global net sales of acoramidis, and may adjust to a maximum rate of 10% (which would take effect in 2027, if certain conditions are met). Each Royalty Interest Payment will become payable to the Purchasers on a quarterly basis after the Funding Date. The Purchasers’ rights to the Royalty Interest Payments and ownership interest in Net Sales will terminate upon the earlier of the Purchasers’ receipt of (a) Royalty Interest Payments equal to $950.0 million (“Cap Amount”) and (b) a buy-out payment (“Buy-Out Payment”) in an amount determined in accordance with the Funding Agreement but that will not exceed the Cap Amount. In addition, we and our subsidiaries granted the collateral agent, for the benefit of the Purchasers, a security interest in specific assets related to acoramidis. The Funding Agreement will terminate upon customary events. Following the FDA approval of Attruby on November 22, 2024, and in accordance with the Funding Agreement, we received gross cash proceeds of $500.0 million in December 2024, and recognized debt discount and issuance costs paid in cash of $27.5 million.
Refer to Footnote 9 of the “ Notes to Consolidated Financial Statements ” for further details.
Government Regulation
Government authorities in the United States at the federal, state and local level and in other countries regulate, among other things, the research, development, manufacture, testing, quality control, approval, labeling, packaging, storage, record-keeping, promotion, advertising, distribution, post-approval monitoring and reporting, marketing and export and import of drug and biological products, including gene therapies, as well as diagnostics, and any future product candidates. Generally, before a new drug, biologic or diagnostic can be marketed, considerable data demonstrating its quality, safety and efficacy must be obtained, organized into a format specific for each regulatory authority, submitted for review and approved, authorized, or cleared by the applicable regulatory authority.
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U.S. Government Regulation of Drug and Biological Products
In the United States, the FDA regulates drugs under the Federal Food, Drug and Cosmetic Act (“FDCA”) and its implementing regulations and biologics under the FDCA and the Public Health Service Act (“PHSA”) and their implementing regulations. Both drugs and biologics also are subject to other federal, state and local statutes and regulations, such as those related to competition. The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state, and local statutes and regulations requires the expenditure of substantial time and financial resources. Failure to comply with the applicable U.S. requirements at any time during the product development process, approval process or following approval may subject an applicant to administrative actions or judicial sanctions. These actions and sanctions could include, among other actions, the FDA’s refusal to approve pending applications, withdrawal of an approval, license revocation, a clinical hold, untitled or warning letters, voluntary or mandatory product recalls or market withdrawals, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts, restitution, disgorgement and civil or criminal fines or penalties. Any agency or judicial enforcement action could have a material adverse effect on our business, the market acceptance of our product candidates, if approved, and our reputation.
Our product candidates must be approved by the FDA through either an NDA or a Biologics License Application (“BLA”) process before they may be legally marketed in the United States. The process generally involves the following:
• completion of extensive preclinical studies in accordance with applicable regulations, including studies conducted in accordance with Good Laboratory Practices (“GLP”) requirements;
• submission to the FDA of an IND, which must become effective before human clinical trials may begin;
• approval by an Institutional Review Board (“IRB”) or independent ethics committee at each clinical trial site before each human trial may be initiated;
• performance of adequate and well-controlled human clinical trials in accordance with applicable IND regulations, Good Clinical Practices (“GCP”) requirements and other clinical trial-related regulations to establish the safety and efficacy of the investigational product for each proposed indication;
• submission to the FDA of an NDA or BLA;
• a determination by the FDA within 60 days of its receipt of an NDA or BLA to accept the filing for review;
• satisfactory completion of one or more FDA pre-approval inspections of the manufacturing facility or facilities where the drug or biologic will be produced to assess compliance with Current Good Manufacturing Practices (“cGMP”) requirements to assure that the facilities, methods and controls are adequate to preserve the drug or biologic’s identity, strength, quality and purity;
• potential FDA audit of the clinical trial sites that generated the data in support of the NDA or BLA;
• payment of user fees for FDA review of the NDA or BLA; and
• FDA review and approval of the NDA or BLA, including consideration of the views of any FDA advisory committee, prior to any commercial marketing or sale of the drug or biologic in the United States.
The preclinical and clinical testing and approval process requires substantial time, effort and financial resources, and the regulatory scheme for drugs and biologics is evolving and subject to change at any time. We cannot be certain that any approvals for our product candidates will be granted on a timely basis, or at all.
Preclinical Studies
Before testing any drug, biological or gene therapy candidate in humans, the product candidate must undergo rigorous preclinical testing. Preclinical studies include laboratory evaluation of product chemistry and formulation, as well as in vitro and animal studies to assess safety and in some cases to establish a rationale for therapeutic use. The conduct of preclinical studies is subject to federal and state regulations and requirements, including GLP regulations for safety/toxicology studies.
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An IND sponsor must submit the results of the preclinical tests, together with manufacturing information, analytical data, any available clinical data or literature and plans for clinical trials, among other things, to the FDA as part of an IND. An IND is a request for authorization from the FDA to administer an investigational product to humans, and must become effective before human clinical trials may begin. Some long-term preclinical testing, such as animal tests of reproductive AEs and carcinogenicity, may continue after the IND is submitted. An IND automatically becomes effective 30 days after receipt by the FDA, unless before that time, the FDA raises concerns or questions related to one or more proposed clinical trials and places the trial on clinical hold. In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin. As a result, submission of an IND may not result in the FDA allowing clinical trials to commence. Additionally, the review of information in an IND submission may prompt FDA to, among other things, scrutinize existing INDs or any marketed products and could generate requests for information or clinical holds on other product candidates or programs.
Clinical Trials
The clinical stage of development involves the administration of the investigational product to healthy volunteers or patients under the supervision of qualified investigators, generally physicians not employed by or under the trial sponsor’s control, in accordance with GCP requirements, which include the requirement that all research subjects provide their informed consent for their participation in any clinical trial. Clinical trials are conducted under protocols detailing, among other things, the objectives of the clinical trial, dosing procedures, subject selection and exclusion criteria and the parameters to be used to monitor subject safety and assess efficacy. Each protocol, and any subsequent amendments to the protocol, must be submitted to the FDA as part of the IND. Furthermore, each clinical trial must be reviewed and approved by an IRB for each institution at which the clinical trial will be conducted to ensure that the risks to individuals participating in the clinical trials are minimized and are reasonable in relation to anticipated benefits. The IRB also approves the informed consent form that must be provided to each clinical trial subject or his or her legal representative, and must monitor the clinical trial until completed. There also are requirements governing the reporting of ongoing clinical trials and completed clinical trial results to public registries. Information about certain clinical trials, including clinical trial results, must be submitted within specific timeframes for publication on the www.clinicaltrials.gov website.
In addition to the submission of an IND to the FDA before initiation of a clinical trial in the United States, certain human clinical trials involving recombinant or synthetic nucleic acid molecules are subject to oversight by institutional biosafety committees (“IBC”) as set forth in the National Institute of Health (“NIH”) Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (“NIH Guidelines”). Under the NIH Guidelines, recombinant and synthetic nucleic acids are defined as (i) molecules that are constructed by joining nucleic acid molecules and that can replicate in a living cell (i.e., recombinant nucleic acids); (ii) nucleic acid molecules that are chemically or by other means synthesized or amplified, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules (i.e., synthetic nucleic acids); or (iii) molecules that result from the replication of those described in (i) or (ii). Specifically, under the NIH Guidelines, supervision of human gene transfer trials includes evaluation and assessment by an IBC, a local institutional committee that reviews and oversees research utilizing recombinant or synthetic nucleic acid molecules at that institution. The IBC assesses the safety of the research and identifies any potential risk to public health or the environment, and such review may result in some delay before initiation of a clinical trial. While the NIH Guidelines are not mandatory unless the research in question is being conducted at or sponsored by institutions receiving NIH funding of recombinant or synthetic nucleic acid molecule research, many companies and other institutions not otherwise subject to the NIH Guidelines voluntarily follow them.
A sponsor who wishes to conduct a clinical trial outside of the United States may, but need not, obtain FDA authorization to conduct the clinical trial under an IND. If a foreign clinical trial is not conducted under an IND, the sponsor may submit data from the clinical trial to the FDA in support of an NDA or BLA. The FDA will accept a well-designed and well-conducted foreign clinical study not conducted under an IND if the study was conducted in accordance with GCP requirements, and the FDA is able to validate the data through an onsite inspection if deemed necessary.
Clinical trials generally are conducted in three sequential phases, known as Phase 1, Phase 2 and Phase 3, which may overlap or be combined.
• Phase 1 clinical trials generally involve a small number of healthy volunteers or disease-affected patients who are initially exposed to a single dose and then multiple doses of the product candidate. The primary purpose of these clinical trials is to assess the metabolism, pharmacologic action, side effect tolerability and safety of the product candidate.
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• Phase 2 clinical trials involve studies in disease-affected patients to evaluate proof of concept and/or determine the dose required to produce the desired benefits. At the same time, safety and further PK and PD information is collected, possible adverse effects and safety risks are identified, and a preliminary evaluation of efficacy is conducted.
• Phase 3 clinical trials generally involve a large number of patients at multiple sites and are designed to provide the data necessary to demonstrate the effectiveness of the product for its intended use, its safety in use and to establish the overall benefit/risk relationship of the product and provide an adequate basis for product labeling.
Post-approval trials, sometimes referred to as Phase 4 clinical trials, may be conducted after initial marketing approval. These trials are used to gain additional experience from the treatment of patients in the intended therapeutic indication and are commonly intended to generate additional safety data regarding use of the product in a clinical setting. In certain instances, the FDA may mandate the performance of Phase 4 clinical trials as a condition of approval of an NDA or BLA.
Progress reports detailing the results of the clinical trials, among other information, must be submitted at least annually to the FDA and written IND safety reports must be submitted to the FDA and the investigators 15 days after the trial sponsor determines the information qualifies for reporting for serious and unexpected suspected AEs, findings from other studies or animal or in vitro testing that suggest a significant risk for human subjects and any clinically important increase in the rate of a serious suspected adverse reaction over that listed in the protocol or investigator brochure. The sponsor must also notify the FDA of any unexpected fatal or life-threatening suspected adverse reaction as soon as possible but in no case later than seven calendar days after the sponsor’s initial receipt of the information.
Phase 1, Phase 2, Phase 3 and other types of clinical trials may not be completed successfully within any specified period, if at all. The FDA or the sponsor may suspend or terminate a clinical trial at any time on various grounds, including a finding that the research subjects or patients are being exposed to an unacceptable health risk. Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution if the clinical trial is not being conducted in accordance with the IRB’s requirements or if the drug or biologic has been associated with unexpected serious harm to patients. Additionally, some clinical trials are overseen by an independent group of qualified experts organized by the clinical trial sponsor, known as a data safety monitoring board or committee. This group provides authorization for whether a trial may move forward at designated check points based on access to certain data from the trial. Concurrent with clinical trials, companies usually complete additional animal studies and also must develop additional information about the chemistry and physical characteristics of the drug or biologic as well as finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements. The manufacturing process must be capable of consistently producing quality batches of the product and, among other things, companies must develop methods for testing the identity, strength, quality and purity of the final product. Additionally, appropriate packaging must be selected and tested, and stability studies must be conducted to demonstrate that the product candidates do not undergo unacceptable deterioration over their shelf life.
FDA Review Process
Following completion of the clinical trials, data are analyzed to assess whether the investigational product is safe and effective for the proposed indicated use or uses. The results of preclinical studies and clinical trials are then submitted to the FDA as part of an NDA or BLA, along with proposed labeling, chemistry and manufacturing information to ensure product quality and other relevant data. The NDA or BLA is a request for approval to market the drug or biologic for one or more specified indications and must contain proof of safety and efficacy for a drug or safety, purity and potency for a biologic. The application may include both negative and ambiguous results of preclinical studies and clinical trials, as well as positive findings. Data may come from company-sponsored clinical trials intended to test the safety and efficacy of a product’s use or from a number of alternative sources, including studies initiated by investigators. To support marketing approval, the data submitted must be sufficient in quality and quantity to establish the safety and efficacy of the investigational product to the satisfaction of FDA. FDA approval of an NDA or BLA must be obtained before a drug or biologic may be marketed in the United States.
Under the Prescription Drug User Fee Act (“PDUFA”), as amended, each NDA or BLA must be accompanied by a user fee. FDA adjusts the PDUFA user fees on an annual basis. Fee waivers or reductions are available in certain circumstances, including a waiver of the application fee for the first application filed by a small business. Additionally, no user fees are assessed on NDAs or BLAs for products designated as orphan drugs, unless the product also includes a non-orphan indication.
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The FDA reviews all submitted NDAs and BLAs before it accepts them for filing, and may request additional information rather than accepting the NDA or BLA for filing. The FDA must make a decision on accepting an NDA or BLA for filing within 60 days of receipt, and such decision could include a refusal to file by the FDA. Once the submission is accepted for filing, the FDA begins an in-depth review of the NDA or BLA. Under the goals and policies agreed to by the FDA under PDUFA, the FDA targets ten months, from the filing date, in which to complete its initial review of a new molecular entity NDA or original BLA and respond to the applicant, and six months from the filing date of a new molecular entity NDA or original BLA designated for priority review. The FDA does not always meet its PDUFA goal dates for standard and priority NDAs or BLAs, and the review process is often extended by FDA requests for additional information or clarification.
Before approving an NDA or BLA, the FDA will conduct a pre-approval inspection of the manufacturing facilities for the new product to determine whether they comply with cGMP requirements. The FDA will not approve the product unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and adequate to assure consistent production of the product within required specifications. The FDA also may audit data from clinical trials to ensure compliance with GCP requirements. Additionally, the FDA may refer applications for novel products or products which present difficult questions of safety or efficacy to an advisory committee, typically a panel that includes clinicians and other experts, for review, evaluation and a recommendation as to whether the application should be approved and under what conditions, if any. The FDA is not bound by recommendations of an advisory committee, but it considers such recommendations when making decisions on approval. The FDA likely will reanalyze the clinical trial data, which could result in extensive discussions between the FDA and the applicant during the review process. After the FDA evaluates an NDA or BLA, it will issue an approval letter or a Complete Response Letter. An approval letter authorizes commercial marketing of the drug or biologic with specific prescribing information for specific indications. A Complete Response Letter indicates that the review cycle of the application is complete, and the application will not be approved in its present form. A Complete Response Letter usually describes all of the specific deficiencies in the NDA or BLA identified by the FDA. The Complete Response Letter may require the applicant to obtain additional clinical data, including the potential requirement to conduct additional pivotal Phase 3 clinical trial(s) and/or to complete other significant and time-consuming requirements related to clinical trials, or to conduct additional preclinical studies or manufacturing activities. If a Complete Response Letter is issued, the applicant may either resubmit the NDA or BLA, addressing all of the deficiencies identified in the letter, or withdraw the application or request an opportunity for a hearing. Even if such data and information are submitted, the FDA may decide that the NDA or BLA does not satisfy the criteria for approval. Data obtained from clinical trials are not always conclusive and the FDA may interpret data differently than we interpret the same data.
Orphan Drug Designation and Exclusivity
Under the Orphan Drug Act, the FDA may grant orphan drug designation to a drug or biological product intended to treat a rare disease or condition, which is generally a disease or condition that affects fewer than 200,000 individuals in the United States, or 200,000 or more individuals in the United States and for which there is no reasonable expectation that the cost of developing and making the product available in the United States for this type of disease or condition will be recovered from sales of the product.
Orphan drug designation must be requested before submitting an NDA or BLA. After the FDA grants orphan drug designation, the identity of the therapeutic agent and its potential orphan use are disclosed publicly by the FDA. Orphan drug designation does not convey any advantage in or shorten the duration of the regulatory review and approval process.
If a product that has orphan drug designation subsequently receives the first FDA approval for the disease or condition for which it has such designation, the product is entitled to orphan drug exclusivity, which means that the FDA may not approve any other applications to market the same drug for the same indication for seven years from the date of such approval, except in limited circumstances, such as a showing of clinical superiority to the product with orphan exclusivity by means of greater effectiveness, greater safety or providing a major contribution to patient care or in instances of drug supply issues. Competitors, however, may receive approval of either a different product for the same indication or the same product for a different indication but that could be used off-label in the orphan indication. Orphan drug exclusivity also could block the approval of our products for seven years if a competitor obtains approval before we do for the same product, as defined by the FDA, for the same indication we are seeking approval, or if our product is determined to be contained within the scope of the competitor’s product for the same indication or disease. In February 2026, Congress passed legislation codifying the FDA’s longstanding regulatory interpretation that orphan drug exclusivity applies only to the specific approved use or indication of a drug or biological product, rather than to all uses within a designated rare disease or condition. If we pursue marketing approval for an indication broader than the orphan drug designation we have received, we may not be entitled to orphan drug exclusivity. Orphan drug status in the European Union has similar, but not identical, requirements and benefits.
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