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BBIO PDUFA Date: Oral infigratinib

Page updated ·next FDA decision on the calendar ·Data as of Nov 5, 2026 5:03 AM ET
FDA decision (PDUFA) target Feb 4, 2027 · BridgeBio Pharma, Inc. · Children with achondroplasia
Source: BridgeBio 8-K 2026-10-06 (EX-99.1, NDA accepted, priority review). “The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of February 4, 2027”

Key facts

FDA PDUFA target date2027-02-04
Drug / candidateOral infigratinib
IndicationChildren with achondroplasia
CompanyBridgeBio Pharma, Inc.
Market-cap tierLarge

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FAQ

When is the BBIO PDUFA date?
The FDA PDUFA target date for BBIO (BridgeBio Pharma, Inc.) is 2027-02-04 for Oral infigratinib. Dates are company/FDA-sourced and can slip. Verify against primary filings.
What is BBIO's drug Oral infigratinib?
Oral infigratinib is BridgeBio Pharma, Inc.'s candidate under FDA review for Children with achondroplasia.