BridgeBio Announces Publication in the New England Journal of Medicine of Phase 3 PROPEL 3 Trial of Oral Infigratinib in Children Living with Achondroplasia

About this update from Bridgebio Pharma, Inc.

- Phase 3 PROPEL 3 data published today in NEJM were simultaneously presented at ICCBH in a late-breaking oral presentation; presentation includes new arm span Z-score data showing a statistically significant improvement versus placebo (LS mean +0.37 SD; p<0.0001), the first and only statistically significant placebo-controlled arm span result reported for an achondroplasia trial at 52 weeks- This is the first and only Phase 3 data for an achondroplasia clinical study published in The New England Journal of Medicine (NEJM), marking BridgeBio’s second NEJM publication in achondroplasia and fourth NEJM publication overall in the last three years - The data includes the largest mean increase in AHV compared to placebo reported in any Phase 3 achondroplasia study (+2.1 cm/year observed mean improvement)- Oral infigratinib is the only therapy to demonstrate statistically significant improvement in body proportionality in a Phase 3 achondroplasia study, with a LS mean treatment difference of –0.05 in children ages 3 to 8 years (p<0.05)- Oral infigratinib was well tolerated, with no discontinuations or serious adverse events related to study drug- BridgeBio intends to submit an NDA to the FDA in the third quarter of 2026 with launch anticipated in early to mid 2027, and an MAA to the EMA in the second half of 2026 PALO ALTO, Calif., June 28, 2026 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage, multi-product biopharmaceutical company focused on developing medicines for genetic conditions, today announced that positive results from PROPEL 3, the global Phase 3 pivotal study of oral infigratinib in children living with achondroplasia, were published as an original research article in the New England Journal of Medicine (NEJM). These data were also presented at the International Congress of Children’s Bone Health (ICCBH) 2026 in a late-breaking oral presentation by Ravi Savarirayan, M.D., Ph.D. of Murdoch Children’s Research Institute, Melbourne, AUS, and global lead investigator for PROPEL 3. "The publication of our pivotal trial data (PROPEL 3) in the New England Journal of Medicine is a defining milestone for the field of skeletal dysplasia that reflects the years of rigorous clinical investigation from investigators and dedication from children and their families to make this breakthrough scienc...

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