BridgeBio Reports Positive Phase 3 Topline Results for Oral Infigratinib with the First Statistically Significant Improvements in Body Proportionality in Achondroplasia

February 12, 2026

PROPEL 3 successfully met the primary endpoint of change from baseline in 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 LS mean was +1.74 cm/year

In a pre-specified exploratory analysis of the key secondary endpoint, oral infigratinib achieved the first statistically significant improvement in body proportionality against placebo in achondroplasia, demonstrating an LS mean treatment difference of -0.05 (p<0.05) against placebo in children younger than 8 years old (>50% of the participants)

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 study drug, 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 (e.g., retinal or corneal)

NDA and MAA submissions planned in second half of 2026 for achondroplasia; oral infigratinib is the only therapeutic option in development for achondroplasia to have Breakthrough Therapy Designation from the FDA

Given the strength of these data, BridgeBio plans to accelerate the development of oral infigratinib in hypochondroplasia, and is enrolling the observational run-in for the Phase 3 trial

PALO ALTO, Calif., Feb. 12, 2026 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a biopharmaceutical company focused on developing medicines for genetic conditions, today announced positive topline results from PROPEL 3, the global Phase 3 pivotal study of oral infigratinib in children living with achondroplasia. BridgeBio will host an investor call on February 12, 2026 at 8:00 am ET to discuss these results.

"Achondroplasia is a genetic condition driven by FGFR3 that affects more than stature alone, with consequences on physical functioning and independence that can impact widely over a person’s lifetime,” said Ravi Savarirayan, M.D., Ph.D. of Murdoch Children’s Research Institute in Melbourne, Australia, and global lead investigator for PROPEL 3. “Infigratinib is the first oral therapy designed to target FGFR3 and directly address the underlying cause of achondroplasia. In the broadest age range studied to date, oral infigratinib has demonstrated the highest and most significant improvement in annualized growth velocity, along with the first statistically significant improvement in body proportionality, in children aged 3 to 8 years, reported for any therapy approved or in development for this condition. Taken together, these best-in-class results highlight the transformative potential for infigratinib to address aspects of achondroplasia beyond linear height, and with a product administered orally.”

PROPEL 3 was a global, one-year, 2:1 randomized, double-blinded placebo-controlled clinical study, evaluating the efficacy and safety of infigratinib in children with achondroplasia aged 3 to <18 years with open growth plates. Key results from the study through Week 52 include:

Primary endpoint:

Change from baseline in annualized height velocity (AHV) superior to placebo, with an LS mean treatment difference of +1.74 cm/year (p<0.0001) and a mean treatment difference of +2.10 cm/year

Secondary endpoints:

Consistent with the primary endpoint, the secondary endpoint of absolute AHV at Week 52 showed a significant improvement with infigratinib compared to placebo, with the infigratinib arm achieving the highest LS mean absolute AHV reported to date in a randomized trial in achondroplasia (5.96 cm/year versus 4.22 cm/year on placebo)
Change from baseline in height Z-score (achondroplasia reference population) was superior to placebo, with an LS mean treatment difference of +0.32 SD (p<0.0001), the largest difference observed in a randomized trial in achondroplasia; the LS mean change from baseline on the treatment arm was +0.41 SD, the largest improvement observed on a treatment arm in a randomized trial for achondroplasia
In a pre-specified exploratory analysis (children younger than 8; >50% of the participants) of the key secondary endpoint of change from baseline in upper-to-lower body proportionality at Week 52, oral infigratinib is the first therapeutic option to show statistical significance against placebo in a randomized trial for achondroplasia, demonstrating an LS mean decrease of -0.05 against placebo (p<0.05)
In the overall population, infigratinib achieved an LS mean decrease of -0.05, the largest reduction observed in a treatment arm in a randomized achondroplasia trial, with a favorable LS treatment difference of -0.02 versus placebo at Week 52 (p=0.1849)

Infigratinib was well-tolerated, with:

No discontinuations related to study drug
No serious adverse events related to study drug
3 cases (4%) of hyperphosphatemia, all mild, transient, asymptomatic, and not requiring dose reductions or discontinuations
No adverse events associated with inhibition of FGFR1 or FGFR2 (e.g., retinal or corneal)
No adverse events associated with CNP analogues: symptomatic hypotension, injection site reactions, or hypertrichosis

“There remains a significant unmet need for therapeutic options that are effective, practical, and less invasive for children living with achondroplasia,” said Daniela Rogoff, M.D., Chief Medical Officer, Skeletal Dysplasia of BridgeBio. “The PROPEL 3 data support the potential of an oral medicine directly targeting FGFR3 overactivity to address important clinical needs, while fitting into daily life for families who are seeking a non-injectable option. These results represent meaningful progress for those who have been waiting for a better approach, and we look forward to advancing this program towards global submissions. We would like to thank the study participants, their families, investigators, and study staff who trusted us and joined us on this journey.”

Based on these results, BridgeBio intends to meet with regulatory authorities to discuss plans for submission of a New Drug Application (NDA) and Marketing Authorization Application (MAA) for infigratinib in the second half of 2026 to support approval. The Company also intends to accelerate the development of infigratinib for hypochondroplasia, and is enrolling participants in the observational run-in for the Phase 3 trial. The Company also has an ongoing clinical trial of infigratinib for the newborn to <3 year old age groups in achondroplasia in the PROPEL Infant & Toddler trial. Infigratinib has received Breakthrough Designation from the FDA for achondroplasia, as well as Orphan Drug Designation (FDA & EMA), Fast Track Designation, and Rare Pediatric Disease Designation.

“Today’s announcement represents another milestone in achondroplasia research and, pending regulatory review, expands available care to include an oral therapeutic option, offering individuals and families additional choice as they consider their healthcare goals and preferences,” said Michael Hughes, Chair of the Biotech Industry Liaison Committee at Little People of America. “BridgeBio’s commitment to engaging with and learning from the dwarfism community reflects a focus on listening to lived experience and recognizing diverse priorities in shaping research efforts. Within this context, the observed improvement in body proportionality with one year of treatment in the PROPEL 3 study is an outcome that individuals and families have identified as meaningful, may be relevant to physical function, and continues to be evaluated to understand its broader significance.”

Information about PROPEL Infant & Toddler trial (NCT07169279) can be found here on clinicaltrials.gov. Information about ACCEL, the Company’s observational lead-in study for infigratinib in hypochondroplasia’s Phase 3 study, (NCT06410976) can be found here, and information about ACCEL 2/3, BridgeBio’s Phase 2/3 clinical study of infigratinib in hypochondroplasia, (NCT06873035) can be found here. BridgeBio is committed to exploring the potential of infigratinib on wider medical and functional impacts of achondroplasia, hypochondroplasia and other skeletal dysplasia conditions, which hold significant unmet needs for families.

Webcast Information

BridgeBio will host an investor call and simultaneous webcast to discuss the results from the Phase 3 PROPEL 3 study of infigratinib in children with achondroplasia on February 12, 2026 at 8:00 am ET. A link to the webcast may be accessed from the event calendar page of BridgeBio’s website at https://investor.bridgebio.com/. A replay of the conference call and webcast will be archived on the Company’s website and will be available for at least 30 days following the event.

About Achondroplasia

Achondroplasia is the most common cause of disproportionate short stature, affecting approximately 55,000 people in the U.S. and European Union (EU), including up to 10,000 children and adolescents with open growth plates. Achondroplasia impacts overall health and quality of life, leading to medical complications such as obstructive sleep apnea, middle ear dysfunction, kyphosis, and spinal stenosis. The condition is uniformly caused by an activating variant in FGFR3.

About BridgeBio Pharma, Inc.

BridgeBio exists to develop transformative medicines for genetic conditions. Millions of people worldwide living with genetic conditions lack treatment options, often because drug development for small patient populations can be commercially challenging. We aim to bridge the gap between advancements in genetic science and meaningful medicines for underserved patient populations. Our decentralized, hub-and-spoke model is designed for speed, precision, and scalability. Autonomous and empowered teams focus on individual conditions, while a central hub provides the clinical, regulatory, and commercial capabilities needed to bring innovation to market. For more information, visit bridgebio.com and follow us on LinkedIn, X, Facebook, Instagram, YouTube, and TikTok.

BridgeBio Forward-Looking Statements

This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act), which are usually identified by the use of words such as “anticipates,” “believes,” “continues”, “estimates,” “expects,” “hopes,” “intends,” “may,” “plans,” “projects,” “remains”, “seeks,” “should,” “will,” and variations of such words or similar expressions, or the negative of these terms or other comparable terminology are intended to identify forward-looking statements, though not all forward-looking statements necessarily contain these identifying words. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act. These forward-looking statements, including express and implied statements relating to the topline results from PROPEL 3, the global Phase 3 pivotal study of oral infigratinib in children living with achondroplasia, the efficacy, safety and the clinical, therapeutic and market potential of oral infigratinib, our expected interactions with regulatory authorities, our plans to submit a New Drug Application and Marketing Authorization Application for infigratinib to the FDA and EMA, as applicable, in the second half of 2026 for treatment of achondroplasia; our plans to accelerate the development of oral infigratinib in hypochondroplasia, the progress of our ongoing and planned clinical trials of infigratinib for the newborn to <3 year old age groups in achondroplasia in the PROPEL Infant & Toddler trial, the statements regarding the potential clinical benefits of oral infigratinib for patients with achondroplasia in the quotes of Dr. Savarirayan, Dr. Rogoff and Mr. Hughes, and our commitment to exploring the potential of infigratinib on wider medical and functional impacts of achondroplasia, hypochondroplasia and other skeletal dysplasia conditions, reflect our current views about our plans, intentions, expectations and strategies, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, initial and ongoing data from our preclinical studies and clinical trials not being indicative of final data, the potential size of the target patient populations our product candidates are designed to treat not being as large as anticipated, the design and success of ongoing and planned clinical trials, difficulties with enrollment in our clinical trials, adverse events that may be encountered in our clinical trials, future regulatory filings, approvals and/or sales, despite having ongoing and future interactions with the FDA or other regulatory agencies to discuss potential paths to registration for our product candidates, the FDA or such other regulatory agencies not agreeing with our regulatory approval strategies, components of our filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted, the continuing success of our collaborations, our ability to obtain additional funding, potential volatility in our share price, the impacts of current macroeconomic and geopolitical events, including changing conditions from the hostilities in Ukraine and in Israel and the Gaza Strip, increasing rates of inflation and changing interest rates, on our overall business operations and expectations, as well as those risks set forth in the Risk Factors section of our most recent Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and our other filings with the U.S. Securities and Exchange Commission. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

BridgeBio Pharma, Inc. (BBIO) — Positive Phase 3 PROPEL 3 result advances infigratinib toward filing

What Happened

Clinical readout: On February 12, 2026, BridgeBio reported that oral infigratinib met the primary Week 52 endpoint in PROPEL 3, a Phase 3 trial in children with achondroplasia, resolving the study’s primary efficacy question positively. (1)
Clinical Results Details: The company reported a placebo-adjusted LS mean annualized height velocity difference of +1.74 cm/year (p<0.0001) and a key secondary height Z-score difference of +0.32 SD (p<0.0001). It also reported no study-drug-related serious adverse events or discontinuations through Week 52. (1)

Trading Background

BBIO was generally higher but volatile into the PROPEL 3 readout, rising from $66.22 on November 12, 2025 to $73.33 on February 11, 2026, about 11%; the broader backdrop included a 17.1% gain on October 27 following positive Phase 3 FORTIFY interim results. The main late dislocation was a 15.2% decline on February 5 during a broader biotech selloff, when XBI fell about 3.6%, with no same-day BridgeBio company release identified; BBIO recovered to $73.33 by February 11. PROPEL 3 results were released at 7:30 a.m. ET on February 12, making February 11 the last clean pre-trigger close. (2) (3)

Confirmed Information Based on Disclosures

Trial scope: BridgeBio described PROPEL 3 as a global, one-year, randomized, double-blind, placebo-controlled study in children aged 3 to under 18 with achondroplasia and open growth plates. (1) (4)
Body proportionality finding: A prespecified exploratory analysis in participants younger than 8—more than half the participants—reported a treatment difference of -0.05 (p<0.05). In the overall population, the difference was -0.02 (p=0.1849). (1)
Regulatory designation: BridgeBio states that infigratinib has FDA Breakthrough Therapy Designation for achondroplasia; the designation is distinct from approval or a finding that the submission package is sufficient. (1)

Key Missing Information

Full clinical data and analysis: The release does not provide missing-data or multiplicity handling, complete adverse-event tables, or longer-term follow-up. Therefore, the precision and robustness of the reported effects, and the longer-term benefit-risk profile, cannot be fully assessed. (1)
Regulatory feedback and filing readiness: BridgeBio disclosed no regulator feedback, meeting timing, or agreement on the proposed package; the NDA and MAA remain planned submissions, not filed applications. Accordingly, the sufficiency of the package and the feasibility of the company’s filing timetable cannot yet be judged. (1)

Company's Response

BridgeBio said it intends to meet with regulators to discuss submission plans and plans NDA and MAA submissions in the second half of 2026. It also said it intends to accelerate infigratinib development in hypochondroplasia and is enrolling participants in an observational run-in for a planned Phase 3 trial; the company described its PROPEL Infant & Toddler study as ongoing. (1) (8) (9)

News Release Framing Risks

The headline’s phrase “statistically significant improvements in body proportionality in achondroplasia” does not identify the age or analysis scope and may imply a significant result across the overall population. The release limits the significant finding for this secondary endpoint to a prespecified exploratory analysis in children younger than 8 and does not report a statistically significant overall-population difference. The finding should therefore be understood as subgroup-specific evidence, not an established overall-population effect. (1)

Analytical Interpretation

Pre-event expectation snapshot: Immediately before the readout, management expected early-2026 PROPEL 3 topline data to resolve whether infigratinib produced sufficiently supportive efficacy and benefit-risk evidence in achondroplasia to support the next development or regulatory step; previous infigratinib growth findings informed that expectation, while the company’s October 2025 update did not give a numerical PROPEL 3 outcome forecast or an achondroplasia NDA/MAA filing timetable. (5) (6)
Post-event change of expectation: The positive reported primary and secondary growth results moved infigratinib from an unresolved pivotal efficacy question to a company-stated regulatory path, alongside a plan to accelerate development in hypochondroplasia. (1) (5)
Integrated assessment:
- PROPEL 3’s positive Week 52 primary outcome resolves the central Phase 3 efficacy question for the studied population and gives BridgeBio a substantive basis to advance the achondroplasia program. (1)
- The aligned height Z-score and absolute annualized height velocity findings, together with the reported one-year tolerability profile, reinforce the linear-growth result. The body-proportionality finding is a separate exploratory signal in children younger than 8; the overall-population difference was not statistically significant (p=0.1849). (1)
- The result enables regulatory consultation and filing preparation, with BridgeBio targeting NDA and MAA submissions in the second half of 2026. If the company proceeds after consultation, the work includes clinical study reports and analyses, safety reporting, CMC and manufacturing modules, and application preparation; regulator feedback and completion of those modules control timing. This is a principally nontrial filing burden with no disclosed budget or supportable cost estimate; a regulator-requested new study would be the main potential additional time and cost driver. September 2025 liquidity of $645.9 million and management’s at-least-12-month runway guidance support near-term execution. (1) (6)
- Against approved injectable vosoritide (Voxzogo), infigratinib’s placebo-controlled growth results and oral route could offer a preference-based distinction for families where injection burden matters. This is a potential treatment-choice feature, not evidence of comparative efficacy, safety, adherence, or durability; the trials are not head-to-head. (1) (7)
- In hypochondroplasia, the shared FGFR3 biology and use of the same drug support a development rationale, and BridgeBio explicitly linked the PROPEL 3 results to its decision to accelerate the program. Run-in enrollment advances a separate planned Phase 3 path, but indication-specific results and substantial additional clinical investment are still required. Management had previously expected ACCEL 2/3 Phase 2 data in the second half of 2026; the announcement did not revise that timing. (1) (5) (8)
- The ongoing PROPEL Infant & Toddler program is a distinct age-expansion path in achondroplasia. The older-child result may strengthen the broader development rationale, while age-specific dose, safety, and controlled efficacy evidence remain necessary to support use in children under 3. (1) (9)
- BridgeBio remains an early-commercial, cash-consuming company: its existing gross profit was materially below operating expenses. The result adds a stronger potential future product gross-profit pathway but does not change current infigratinib revenue or cash generation; a contribution would depend on authorization and commercialization, with operating leverage requiring product gross profit to scale faster than associated costs. (6)
- Realization proceeds through regulator feedback, completion of filing modules, actual NDA and MAA submissions, and regulatory review; authorization would then enable commercial preparation and potential product revenue and gross profit. Separately, hypochondroplasia run-in completion, finalized trial design, and indication-specific results will determine whether early optionality becomes a broader franchise. (1) (8) (9)
- Overall implication of this event: BridgeBio moves from an early-commercial, cash-consuming company with infigratinib’s pivotal achondroplasia efficacy unresolved to the same operating model with a materially improved asset and a defined company-stated filing path, strengthening a potential future gross-profit source; regulator feedback and actual submissions are the principal conditions for a larger financial effect. (1) (6)