PALO ALTO, Calif. — February 12, 2026 — Leads & Copy — BridgeBio Pharma, Inc. (Nasdaq: BBIO) has announced positive topline results from its PROPEL 3 global Phase 3 pivotal study of oral infigratinib in children with achondroplasia. The company plans to host an investor call on February 12, 2026, at 8:00 a.m. ET to discuss the results.
The PROPEL 3 study met its primary endpoint, demonstrating a statistically significant change from baseline in annualized height velocity (AHV) at Week 52 (p<0.0001). The change from baseline in AHV was superior to placebo at Week 52, with a mean treatment difference of +2.10 cm/year and an LS mean of +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. This was observed in children younger than 8 years old, representing over 50% of the participants, with an LS mean treatment difference of -0.05 (p<0.05) against placebo.
Additionally, the study 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.
According to the company, oral infigratinib was well tolerated in the study. There were no discontinuations or serious adverse events related to the study drug. Three cases (4%) of hyperphosphatemia were reported, considered mild and transient, with no cases requiring dose reduction or discontinuation. There were no adverse events associated with inhibition of FGFR1 or 2 (e.g., retinal or corneal).
BridgeBio plans to submit New Drug Application (NDA) and Marketing Authorization Application (MAA) in the second half of 2026 for achondroplasia. Oral infigratinib is the only therapeutic option in development for achondroplasia with Breakthrough Therapy Designation from the FDA.
Based on the data, BridgeBio plans to accelerate the development of oral infigratinib in hypochondroplasia and is enrolling the observational run-in for the Phase 3 trial.
PROPEL 3 was a global, one-year, 2:1 randomized, double-blinded, placebo-controlled clinical study. It evaluated the efficacy and safety of infigratinib in children with achondroplasia aged 3 to <18 years with open growth plates.
The study also showed that consistent with the primary endpoint, the secondary endpoint of absolute AHV at Week 52 showed a significant improvement with infigratinib compared to placebo. The infigratinib arm achieved 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).
In the overall population, infigratinib achieved an LS mean decrease of -0.05, with a favorable LS treatment difference of -0.02 versus placebo at Week 52 (p=0.1849).
Daniela Rogoff, M.D., Chief Medical Officer, Skeletal Dysplasia of BridgeBio, said there remains a significant unmet need for therapeutic options that are effective, practical, and less invasive for children living with achondroplasia.
Michael Hughes, Chair of the Biotech Industry Liaison Committee at Little People of America, said 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.
Achondroplasia is the most common cause of disproportionate short stature, affecting approximately 55,000 people in the U.S. and European Union (EU). The condition is uniformly caused by an activating variant in FGFR3.
BridgeBio exists to develop transformative medicines for genetic conditions. The company’s decentralized, hub-and-spoke model is designed for speed, precision, and scalability.
More information about PROPEL Infant & Toddler trial (NCT07169279) can be found here. 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 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.
Source: BridgeBio Pharma, Inc.
