Plano ng Immunome na magsumite ng NDA para sa varegacestat sa 2Q 2026

Inihayag ng kumpanya ang positibong Phase 3 RINGSIDE topline results para sa varegacestat sa desmoid tumors at sinabi nitong magsusumite sila ng NDA sa FDA sa ikalawang quarter ng 2026. Tinutukoy nito ang susunod na regulatory milestone bilang ang NDA filing mismo sa halip na isang PDUFA date.

Mahahalagang fact

Na-file: Mar 3, 2026, 09:05 PM
Kaganapan: Naisumite ang aplikasyon
Direksyon: Positibo
Kumpanya: IMNMImmunome
Asset: varegacestat
Pinagmulan: SEC 8-K
Kumpiyansa: May source
ORR: 56% kumpara sa 9%
PFS HR: 0.16

Sipi mula sa source

EX-99.1 2 imnm-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Immunome Reports Full Year 2025 Financial Results and Provides Business Update Mar. 3, 2026 • New Drug Application submission for varegacestat in patients with desmoid tumors planned for 2Q 2026 • IM-1021 Phase 1 ongoing with initial data expected in 2026 • Three IND submissions for solid tumor-targeted ADC programs planned in 2026 • Underwritten public offering in December 2025 raised $460.5 million in gross proceeds, extending projected cash runway into 2028 BOTHELL, Wash. – Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, today announced financial results for the full year ended December 31, 2025, and provided a business update. “Immunome

SEC 8-K