Immunome: Itinakda ng FDA ang Abril 28, 2027 PDUFA para sa varegacestat NDA sa mga desmoid tumor

Tinanggap ng FDA ang NDA para sa varegacestat at nagtalaga ng PDUFA target action date na Abril 28, 2027. Natugunan ng Phase 3 RINGSIDE trial ang pangunahing endpoint nito (HR 0.16) at lahat ng pangunahing secondary endpoints, kasama ang 56% ORR. Plano ng kumpanya na magsumite ng MAA sa EMA bago matapos ang taon 2026.

Mahahalagang fact

Na-file: Ago 11, 2026, 08:05 PM
Kaganapan: Naitakda ang petsa ng PDUFA
Direksyon: Positibo
Kumpanya: IMNMImmunome
Asset: varegacestat
Pinagmulan: SEC 8-K
Kumpiyansa: May source
Kalendaryo: Desisyon ng FDA (PDUFA) · Abr 28, 2027 · Positibo
HR: 0.16
ORR: 56% kumpara sa 9%
Pagbawas ng panganib (PFS): 84%

Sipi mula sa source

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