Immunome: datos topline positivos de la fase 3 RINGSIDE para varegacestat en tumores desmoides

The registrational Phase 3 RINGSIDE trial met its primary PFS endpoint (HR 0.16, p<0.0001) and all key secondaries including ORR 56% vs 9%. Immunome plans to submit an NDA to FDA in Q2 2026 based on these data.

Datos clave

Presentado: 15 dic 2025, 12:05
Evento: Resultados principales
Dirección: Positivo
Empresa: IMNMImmunome
Activo: varegacestat
Fuente: SEC 8-K
Confianza: Con fuente
Calendario: Decisión de la FDA (PDUFA) · 28 abr 2027 · Positivo

Extracto de la fuente

EX-99.1 2 d793961dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 Immunome Announces Positive Topline Results from Phase 3 RINGSIDE Trial of Varegacestat in Patients with Desmoid Tumors Registrational trial met primary endpoint, with varegacestat significantly improving progression-free survival vs. placebo (hazard ratio = 0.16, p<0.0001) Trial also met all key secondary endpoints, with varegacestat delivering an objective response rate of 56% Varegacestat was generally well tolerated with a manageable safety profile New Drug Application submission to U.S. FDA planned for Q2 2026 Company to host conference call today at 8:30 a.m. ET BOTHELL, Wash., December 15, 2025 – Immunome, Inc. (Nasdaq: IMNM), a biotechnology company committed to developing first-in-class and best-in-class targeted

SEC 8-K