FDA accepts BridgeBio's NDA for oral infigratinib in achondroplasia, grants priority review

BridgeBio Pharma announced on October 6, 2026 that the FDA had accepted for filing its New Drug Application with Priority Review for oral infigratinib for the treatment of children with achondroplasia.¹ The FDA has assigned a Prescription Drug User Fee Act target action date of February 4, 2027, and BridgeBio said it is prepared to launch oral infigratinib upon approval.¹

The filing is based on the Phase 3 trial "PROPEL 3." The study met its primary endpoint of change from baseline in annualized height velocity at Week 52, with an LS mean treatment difference of +1.74 cm/year and a mean treatment difference of +2.10 cm/year, p<0.0001, along with a secondary measure tracking height Z-score change from baseline, also reaching p<0.0001.¹ In a subgroup analysis covering more than half the participants, oral infigratinib became the first therapeutic option to show a statistically significant improvement in body proportionality against placebo in a randomized achondroplasia trial.¹ The company reported that oral infigratinib was well tolerated, with no discontinuations or serious adverse events related to study drug.¹

The drug previously earned Breakthrough Therapy Designation from the FDA, which BridgeBio said was based on results from the PROPEL 2 clinical trial, which met the FDA's requirement of potentially demonstrating substantial improvement in efficacy over available therapies on clinically significant endpoints.¹ It also holds Orphan Drug Designation, Fast Track Designation, and Rare Pediatric Disease Designation for achondroplasia from the FDA, as well as Orphan Drug Designation from the EMA.¹

BridgeBio said it intends to submit a Marketing Authorization Application for achondroplasia to the European Medicines Agency in the fourth quarter of 2026.¹ The 8-K was signed by Thomas Trimarchi, President and Chief Financial Officer, on October 13, 2026.