BridgeBio submits drug application to FDA for rare muscle disease
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BridgeBio Submits NDA to FDA for BBP-418 for Individuals Living with LGMD2I/R9
March 30, 2026 7:30 AM EDT- Comprehensive submission includes interim Phase 3 FORTIFY data demonstrating BBP-418s rapid, consistent treatment effect and favorable safety profile, with statistically significant and clinically meaningful improvements in ambulation and pulmonary function
- Based on ongoing discussions with the FDA, BridgeBio anticipates approval with a U.S. launch anticipated in late 2026/early 2027
- If approved, BBP-418 has the potential to become the first and only therapy for individuals living with LGMD2I/R9 and may represent the first approved treatment for any form of LGMD
PALO ALTO, Calif., March 30, 2026 (GLOBE NEWSWIRE) -- BridgeBio... More
