BridgeBio submits FDA NDA for BBP-418 in LGMD2I/R9

Reuters03-30

BridgeBio submits FDA NDA for BBP-418 in LGMD2I/R9

BridgeBio submitted New Drug Application to FDA seeking approval of oral BBP-418 for limb-girdle muscular dystrophy type 2I/R9.
Filing included interim Phase 3 FORTIFY data showing statistically significant improvements in ambulation and pulmonary function.
Company expects FDA decision to support U.S. launch in late 2026 or early 2027.
Fast Track status could make application eligible for Priority Review.

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: 202603300730PRIMZONEFULLFEED9680443) on March 30, 2026, and is solely responsible for the information contained therein.

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