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APR 28 2027
UPCOMING · 211 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 growths that arise from connective tissue and can invade nearby organs, causing pain or life-threatening complications when they press on intestines, kidneys, or blood vessels. Varegacestat is an oral drug that inhibits the gamma-secretase enzyme. By blocking this enzyme, the drug may interfere with a cellular pathway that drives tumor growth, potentially slowing the progression of 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