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Immunome Announces EMA Validation of Marketing Authorization Application for Varegacestat for the Treatment of Adults with Desmoid Tumors

Key Takeaway: Immunome, Inc. announced the European Medicines Agency has validated its Marketing Authorization Application for varegacestat. This investigational oral gamma secretase inhibitor aims to treat adults with desmoid tumors. The validation indicates that the application is complete and ready for further review.

Market Sentiment Analysis

POSITIVE FACTORS

  • EMA validated the MAA for varegacestat.
  • Varegacestat is an investigational oral therapy.
  • Targets treatment for adults with desmoid tumors.

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Best trade, last catalyst
+27%
120-day peak, hindsight
Typical move
28.8%
average across 3 past catalysts
Cash runway
~23 mo
Low dilution risk
Lead asset
IM-1021
Phase 1 · Solid Malignancies

Full Press Release Details

BOTHELL, Wash.--(BUSINESS WIRE)--Immunome, Inc. (Nasdaq: IMNM), a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies, today announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for varegacestat, an investigational, oral, once-daily gamma secretase inhibitor (GSI), for the treatment of adults with desmoid tumors. Validation confirms that the application is complete,

Frequently Asked Questions

What is varegacestat?

Varegacestat is an investigational oral gamma secretase inhibitor.

What condition does varegacestat target?

It targets the treatment of adults with desmoid tumors.

Who validated the MAA for varegacestat?

The European Medicines Agency validated the MAA.

What does EMA validation indicate?

It indicates that the application is complete and ready for review.

Last updated: Oct 30, 2026