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FDA Accepts Immunome NDA for Varegacestat; PDUFA Date Set for 2027

Jul 8, 2026, 7:35 AM EDT1 sourcesAI-analyzed

Why it may matterVerify against the original reporting

NDA acceptance plus a concrete PDUFA date provides a defined catalyst; the Phase 3 results dramatically strengthen the value proposition, potentially driving a multi-bagger move if approved, though label risk and market size temper upside.

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What happened, with direct paths to the underlying reporting

Immunome's NDA for varegacestat was accepted, with a PDUFA target date of April 28, 2027. Phase 3 RINGSIDE shows strong efficacy (HR 0.16; ORR 56%), notable tumor shrinkage (-83%), and a manageable safety profile, supporting potential regulatory approval and a meaningful option for desmoid tumors.

FDA accepts Immunome's NDA for varegacestat; PDUFA target date: Apr 28, 2027.
Phase 3 RINGSIDE: HR 0.16; ORR 56% vs 9% placebo.
Tumor volume median change: -83% vs +11% with placebo.
Common AEs include diarrhea 82%; pain improvement by week 12.

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FDA Accepts Immunome NDA for Varegacestat; PDUFA Date Set for 2027

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