Immunome: FDA tetapkan PDUFA 28 April 2027 untuk NDA varegacestat pada tumor desmoid

FDA menerima NDA untuk varegacestat dan menetapkan tanggal aksi target PDUFA pada 28 April 2027. Uji coba Fase 3 RINGSIDE mencapai titik akhir primer (HR 0.16) dan semua titik akhir sekunder utama, termasuk ORR 56%. Perusahaan berencana mengajukan MAA ke EMA pada akhir tahun 2026.

Fakta utama

Diajukan: 11 Agu 2026, 20.05
Peristiwa: Tanggal PDUFA ditetapkan
Arah: Positif
Perusahaan: IMNMImmunome
Aset: varegacestat
Sumber: SEC 8-K
Keyakinan: Bersumber
Kalender: Keputusan FDA (PDUFA) · 28 Apr 2027 · Positif
HR: 0.16
ORR: 56% berbanding 9%
pengurangan PFS: 84%

Kutipan sumber

EX-99.1 2 imnm-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Immunome Reports Second Quarter 2026 Financial Results and Provides Business Update August 11, 2026 • Varegacestat PDUFA target action date set for April 28, 2027, following U.S. FDA acceptance of New Drug Application (NDA) for adults with desmoid tumors • Detailed Phase 3 RINGSIDE data presented in an oral session at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, demonstrating statistically significant improvements across the primary and all key secondary endpoints • First patient dosed in June 2026 in Phase 1 trial of IM-1617, a potential first-in-class solid tumor antibody-drug conjugate incorporating HC74, Immunome’s proprietary TOP1 inhibitor payload • First patient dosed in July 2026 in Phase 1 trial

SEC 8-K