BridgeBio Pharma (BBIO) Stock News

BridgeBio Pharma announced FDA acceptance and Priority Review of its New Drug Application for oral infigratinib for children with achondroplasia, with a PDUFA target date of February 4, 2027. The Phase 3 PROPEL 3 trial met its primary endpoint of annualized height velocity and showed statistically significant improvements in body proportionality and arm span. The company is prepared for a US launch upon approval and plans an EMA submission in Q4 2026.

BridgeBio reported new cardiac data from the Phase 3 FORTIFY trial of BBP-418 in LGMD2I/R9. At Month 12, 100% of treated patients with elevated HS troponin I returned to normal versus 40% on placebo. LVEF stabilized or improved in 54% of treated patients versus 25% on placebo. Glycosylated alpha-DG was restored to asymptomatic carrier levels. BBP-418 is under FDA Priority Review with a PDUFA date of November 27, 2026.

BridgeBio Pharma has reached an agreement with the US government to expand access to its drug Attruby under Medicaid and Medicare Part D. The deal does not include future pricing mandates.