BridgeBio Pharma Says FDA Accepts Muscular Dystrophy Drug Application for Priority Review

MT Newswires Live

05/27

BridgeBio Pharma (BBIO) said Wednesday the US Food and Drug Administration accepted its New Drug Application for BBP-418, an experimental treatment for a form of limb-girdle muscular dystrophy, and granted the drug priority review.

The company said FDA set a target action date of Nov. 27, 2026, and is not currently planning to hold an advisory committee meeting on the application.

BridgeBio said BBP-418 met all primary and secondary endpoints in the phase 3 trial, with treated patients showing improvement while placebo recipients declined across key measures.

Shares of the company were up 3% in Wednesday's premarket trading.

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