FDA Grants Priority Review to BridgeBio's Oral Infigratinib for Achondroplasia, PDUFA Feb 4, 2027
BBIO sits 28% above its 52-week low of $52.
Summary
The FDA accepted BridgeBio's NDA for oral infigratinib in children with achondroplasia and granted Priority Review, setting a PDUFA target action date of February 4, 2027. This is the first oral therapy candidate for the condition and would be a first-in-class approval if cleared. The filing is backed by Phase 3 PROPEL 3 data showing a +2.10 cm/yr annualized height velocity improvement (p<0.0001) and the first statistically significant gains in body proportionality and arm span in a randomized achondroplasia trial. BridgeBio plans a U.S. launch upon approval and an EMA submission in Q4 2026. The Priority Review designation shortens the review clock to six months, putting a potential approval decision roughly four months out. This follows the September 9 release of 52-week PROPEL 3 data and the October 5 FORTIFY trial success for BBP-418, reinforcing a strong late-stage pipeline narrative.
At the time of this announcement, BBIO was trading at $66.39 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $12.9B. The 52-week trading range was $52.00 to $93.42. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: GlobeNewswire.