As of Oct 26, 2026: BridgeBio Pharma (BBIO) has a PDUFA date for BBP-418 on Nov 27, 2026, in 32 days. Its Quality Score is 3. Scores as of 8:36 PM ET, 15 minutes behind.

BridgeBio Pharma (BBIO) logo

BBIO FDA decision on BBP-418

BridgeBio Pharma · PDUFA date

What the company said

“three planned NDAs are now submitted to the FDA: BBP-418 for LGMD2I/R9 was accepted with Priority Review (PDUFA November 27, 2026)”

PDUFA date, Nov 27, 2026. As BridgeBio Pharma stated in its 8-K of Aug 10, 2026 (the filing).

A PDUFA date is the day the FDA has said it aims to decide on a drug. The FDA can decide earlier, or extend its review, often by three months.

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