FDA accepts NDA for BBP-418 with Priority Review, PDUFA target November 27, 2026
BridgeBio announced FDA acceptance of its New Drug Application for BBP-418 to treat LGMD2I/R9, a rare genetic muscular dystrophy, with a Priority Review designation and potential November 2026 approval. If approved, BBP-418 would be the first therapy for LGMD2I/R9 and the first approved treatment for any form of LGMD, addressing a significant unmet medical need.
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