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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