AVMAPKI FAKZYNJA CO-PACK (Blister Pack) PDUFA date: FDA decision expected February 7, 2027
The FDA is expected to decide on AVMAPKI FAKZYNJA CO-PACK (Blister Pack) from Verastem, Inc. by the PDUFA target action date of February 7, 2027. 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 November 6, 2026. How we check dates. Confirm dates against the company's or the FDA's announcement before acting.
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Questions about this FDA decision
- When is the PDUFA date for AVMAPKI FAKZYNJA CO-PACK (Blister Pack)?
- The FDA's PDUFA target action date for AVMAPKI FAKZYNJA CO-PACK (Blister Pack) is February 7, 2027. The FDA can act before that date, and the review can be extended.
- Which company is developing AVMAPKI FAKZYNJA CO-PACK (Blister Pack)?
- Verastem, Inc. (VSTM).
- 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).