Upcoming FDA decision · November 27, 2026
BBP-418 PDUFA date: FDA decision expected November 27, 2026
42 days to goBridgeBio Pharma, Inc. (BBIO) →
The FDA is expected to decide on BBP-418 from BridgeBio Pharma, Inc. in Limb-girdle muscular dystrophy type 2I/R9 by the PDUFA target action date of November 27, 2026. For Limb-girdle muscular dystrophy type 2I/R9. NDA, Priority Review. Verified against the company announcement on 2026-10-16.
A PDUFA date is the FDA's target deadline to complete its review of a drug application — approval, a complete response letter (CRL), or an extension are all possible. What is a PDUFA date? This page is research information, not financial advice.
Source: sec.gov · Data checked October 16, 2026. Confirm dates against the company's or the FDA's announcement before acting.
November 27
Target action date
NDA
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Verified
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FDA designations
Questions about this FDA decision
- When is the PDUFA date for BBP-418?
- The FDA's PDUFA target action date for BBP-418 is November 27, 2026. The FDA can act before that date, and the review can be extended.
- What is BBP-418 being reviewed for?
- The application under FDA review covers Limb-girdle muscular dystrophy type 2I/R9.
- Which company is developing BBP-418?
- BridgeBio Pharma, Inc. (BBIO).
- What can happen on a PDUFA date?
- The FDA approves the application, issues a complete response letter (CRL) listing what must be fixed before approval, or extends the review (typically by three months after a major amendment).