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Home/News Feed/BridgeBio submits NDA for BBP-418, potential first therapy for LGMD2I/R9, aiming for FDA approval in late 2026.
BBIO
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BridgeBio submits NDA for BBP-418, potential first therapy for LGMD2I/R9, aiming for FDA approval in late 2026.

Market News
30 Mar 2026
GlobeNewsWire
View Source
Bullish
pluang ai news

BridgeBio Pharma has submitted a New Drug Application (NDA) to the FDA for BBP-418, an oral treatment for limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9). The submission includes positive interim Phase 3 trial data showing significant improvements in patient mobility and lung function, with a favorable safety profile. If approved, BBP-418 would be the first therapy for LGMD2I/R9 and possibly the first for any form of LGMD, with a U.S. launch expected in late 2026 or early 2027. BridgeBio is also seeking expedited approval pathways in Europe and plans further clinical trials for younger patients and related conditions.

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