Immunome: Fase 3 RINGSIDE com resultados positivos para varegacestat em tumores desmoides

O ensaio registracional Fase 3 RINGSIDE atingiu seu endpoint primário de SLP (HR 0.16, p<0.0001) e todos os endpoints secundários chave, incluindo ORR de 56% vs 9%. A Immunome planeja submeter uma NDA à FDA no 2T 2026 com base nesses dados.

Fatos principais

Arquivado: 15 de dez. de 2025, 12:05
Evento: Resultados topline
Direção: Positivo
Empresa: IMNMImmunome
Ativo: varegacestat
Fonte: SEC 8-K
Confiança: Com fonte
Calendário: Decisão da FDA (PDUFA) · 28 de abr. de 2027 · Positivo

Trecho da fonte

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