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PDUFAApproval decision

Varegacestat (Gamma Secretase Inhibitor)

Desmoid Tumors

IMNMImmunome
Expected catalystApril 28, 2027Company guidance: Apr 28, 2027

Catalyst overview

Event details

Drug or asset
Varegacestat (Gamma Secretase Inhibitor)
Development stage
PDUFA
Event type
Approval decision
Indication
Desmoid Tumors

Research summary

What is being tracked?

This catalyst tracks a PDUFA approval decision for Varegacestat (Gamma Secretase Inhibitor) in Desmoid Tumors. The expected timing is based on the latest available company guidance and may change.

Development notes

08/11/26:- NDA acceptance and PDUFA April 28, 2027 reiterated. EU MAA planned by end of 2026.

Verification

Primary source

Confirm timing and program details against the company announcement or filing.

Open source

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Industry
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Pipeline assets
7
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Updated Aug 23, 2026. Dates can change; this is not investment advice.

Disclaimer: Biotech Stock Intel is an independent research platform. Information is provided for informational purposes only and is not investment or medical advice. Always verify catalyst dates against primary sources and conduct your own research.
Biotech Stock Intel© 2026 Biotech Stock Intel
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