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ODINSIGNAL JOURNAL · NEWS & EVENTS

FDA decision on BBP-418 for muscular dystrophy slated for Nov 27 2026

BridgeBio Pharma’s BBP-418 (ribitol) has a PDUFA target date of November 27 2026 for Limb Girdle Muscular Dystrophy Type 2i.

OdinSignal science editorial poster: FDA decision on BBP-418 for muscular dystrophy slated for Nov 27 2026
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At a glance

Date
2026-11-27

BridgeBio Pharma’s ribitol candidate BBP-418 is under FDA review for Limb Girdle Muscular Dystrophy Type 2i. The agency’s PDUFA calendar lists a target decision date of November 27 2026 for this application. The deadline is set by the FDA and may shift if the agency issues an extension or requests additional data.

On that day the FDA will either grant approval or issue a Complete Response Letter outlining required changes. The outcome will be closely watched by patients, clinicians, and investors interested in this rare‑disease therapy.

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