BridgeBio says FDA accepts BBP-418 NDA for LGMD2I/R9, grants priority review
BridgeBio Pharma
BridgeBio Pharma BBIO | 0.00 |
- BridgeBio won FDA Priority Review acceptance for its BBP-418 NDA in limb-girdle muscular dystrophy type 2I/R9.
- PDUFA target action date set for Nov. 27, 2026; FDA does not currently plan an advisory committee meeting.
- Approval would position BBP-418 as the first FDA-cleared therapy for LGMD2I/R9, potentially the first for any LGMD.
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: 202605270730PRIMZONEFULLFEED9727097) on May 27, 2026, and is solely responsible for the information contained therein.
