Posted by Michael Wonder on 28 May 2026
BridgeBio announces FDA acceptance and priority review of NDA for BBP-418 for LGMD2I/R9
27 May 2026 - BridgeBio Pharma today announced the FDA has accepted for filing its new drug application with priority review for oral BBP-418 for the treatment of individuals living with limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9).
The FDA has assigned a PDUFA target action date of 27 November 2026, and BridgeBio is poised to launch BBP-418 upon approval.
The FDA also notified the Company that it is not currently planning to hold an advisory committee meeting to discuss the application.
