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How FDA Priority Review for First-in-Class LGMD Drug BBP-418 Could Impact BridgeBio Pharma (BBIO) Investors
BridgeBio Pharma announced that the FDA previously accepted and granted Priority Review to its New Drug Application for oral BBP-418 in LGMD2I/R9, setting a PDUFA target action date of November 27, 2026, without planning an advisory committee meeting.
If approved, BBP-418 would be the first therapy for LGMD2I/R9 and any limb-girdle muscular dystrophy, potentially qualifying BridgeBio for a Priority Review Voucher and opening up further rare disease development paths.
We’ll now examine how...