AL102 PDUFA date: FDA decision expected April 28, 2027
The FDA is expected to decide on AL102 from Immunome Inc. in adults with desmoid tumors by the PDUFA target action date of April 28, 2027. For adults with desmoid tumors. 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 20, 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 AL102?
- The FDA's PDUFA target action date for AL102 is April 28, 2027. The FDA can act before that date, and the review can be extended.
- What is AL102 being reviewed for?
- The application under FDA review covers adults with desmoid tumors.
- Which company is developing AL102?
- 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).