BridgeBio says FDA accepts infigratinib NDA for achondroplasia, grants priority review

• BridgeBio won FDA Priority Review for its NDA of oral infigratinib to treat children with achondroplasia.
• PDUFA target action date set for Feb. 4, 2027.
• Approval would make infigratinib the first FDA-cleared oral therapy for achondroplasia; BridgeBio plans a U.S. launch upon clearance.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. BridgeBio Pharma Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202610060730PRIMZONEFULLFEED9840252) on October 06, 2026, and is solely responsible for the information contained therein.