Immunome berencana mengajukan NDA untuk varegacestat pada 2Q 2026

Perusahaan mengumumkan hasil topline positif dari uji coba Fase 3 RINGSIDE untuk varegacestat pada tumor desmoid dan menyatakan akan mengajukan NDA ke FDA pada kuartal kedua tahun 2026. Hal ini menjadikan tonggak regulasi berikutnya sebagai pengajuan NDA itu sendiri, bukan tanggal PDUFA.

Fakta utama

Diajukan: 3 Mar 2026, 21.05
Peristiwa: Permohonan diajukan
Arah: Positif
Perusahaan: IMNMImmunome
Aset: varegacestat
Sumber: SEC 8-K
Keyakinan: Bersumber
ORR: 56% berbanding 9%
PFS HR: 0.16

Kutipan sumber

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