Upcoming FDA decision · April 28, 2027
IM-1617 PDUFA date: FDA decision expected April 28, 2027
192 days to goImmunome Inc. (IMNM) →
The FDA is expected to decide on IM-1617 from Immunome Inc. in adults with desmoid tumors and assigned a PDUFA target action date of April 28 by the PDUFA target action date of April 28, 2027. For adults with desmoid tumors and assigned a PDUFA target action date of April 28. nda filing. Extracted from SEC filing: EX-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 18, 2026. Confirm dates against the company's or the FDA's announcement before acting.
April 28
Target action date
NDA
Stage
Verified
Date confidence
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FDA designations
Questions about this FDA decision
- When is the PDUFA date for IM-1617?
- The FDA's PDUFA target action date for IM-1617 is April 28, 2027. The FDA can act before that date, and the review can be extended.
- What is IM-1617 being reviewed for?
- The application under FDA review covers adults with desmoid tumors and assigned a PDUFA target action date of April 28.
- Which company is developing IM-1617?
- Immunome Inc. (IMNM).
- 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).