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APR 29 2027
UPCOMING · 272 DAYS TO PDUFA

Immunome varegacestat $IMNM

for desmoid tumors (locally aggressive soft-tissue tumors)

NDA · Standard Review

Accepted JUL 8 2026.

About

Desmoid tumors are rare, non-metastatic growths that arise from connective tissue cells and can become locally aggressive, invading nearby soft tissues and sometimes compressing vital organs to cause pain or life-threatening problems. Varegacestat is an oral drug designed to inhibit the gamma-secretase enzyme. By blocking this enzyme, the drug may interfere with a key cellular signaling pathway that drives tumor growth, potentially offering a way to control these invasive tumors.

Pivotal trial

RINGSIDE Phase 2/Phase 3 active not recruiting NCT04871282

The current study is designed to evaluate the efficacy and safety of AL102 in patients with progressive desmoid tumors.

Source: ClinicalTrials.gov

Also in development