Upcoming FDA decision · February 4, 2027
Infigratinib PDUFA date: FDA decision expected February 4, 2027
111 days to goBridgeBio Pharma, Inc. (BBIO) →
The FDA is expected to decide on Infigratinib from BridgeBio Pharma, Inc. in children with achondroplasia by the PDUFA target action date of February 4, 2027. For children with achondroplasia. nda filing. Extracted from SEC filing: EXHIBIT 99.1
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.
February 4
Target action date
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Questions about this FDA decision
- When is the PDUFA date for Infigratinib?
- The FDA's PDUFA target action date for Infigratinib is February 4, 2027. The FDA can act before that date, and the review can be extended.
- What is Infigratinib being reviewed for?
- The application under FDA review covers children with achondroplasia.
- Which company is developing Infigratinib?
- 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).