# Varegacestat PDUFA Event: Desmoid tumors

Canonical URL: https://biopharmsignal.com/pdufa-calendar/IMNM/varegacestat-desmoid-tumors

Ticker: IMNM

Company: Immunome

Event date: 2027-04-28

Event type: FDA Decision

Stage: PDUFA

Result: Pending

Application type: NDA

FDA decision expected. FDA assigned April 28, 2027 as the PDUFA target action date for the varegacestat NDA in adults with desmoid tumors.

## Event Timeline

### April 28, 2027 — FDA decision expected

FDA assigned April 28, 2027 as the PDUFA target action date for the varegacestat NDA in adults with desmoid tumors.

[Immunome — NDA acceptance and PDUFA date](https://investors.immunome.com/immunome-announces-u-s-fda-acceptance-of-new-drug-application-for-varegacestat-for-the-treatment-of-adults-with-desmoid-tumors/)

### July 8, 2026 — FDA accepted the NDA for review

FDA accepted Immunome's NDA for the investigational oral gamma-secretase inhibitor varegacestat in adults with desmoid tumors.

[Immunome — FDA acceptance announcement](https://investors.immunome.com/immunome-announces-u-s-fda-acceptance-of-new-drug-application-for-varegacestat-for-the-treatment-of-adults-with-desmoid-tumors/)

### June 2026 — Detailed RINGSIDE Phase 3 data were presented

Detailed Phase 3 RINGSIDE data presented at ASCO showed statistically significant improvements across the primary and all key secondary endpoints.

[Immunome — RINGSIDE Phase 3 data update](https://investors.immunome.com/immunome-reports-second-quarter-2026-financial-results-and-provides-business-update/)

## Related Pages

- IMNM PDUFA calendar: https://biopharmsignal.com/pdufa-calendar/IMNM.md

- IMNM company profile: https://biopharmsignal.com/company/IMNM.md

- PDUFA calendar: https://biopharmsignal.com/pdufa-calendar.md