Nagsumite ang Immunome ng NDA para sa varegacestat sa desmoid tumors

Nagpasumite ang Immunome ng NDA sa FDA noong Abril 2026 para sa varegacestat sa mga nasa hustong gulang na may desmoid tumors. Ang pagsusumite ay kasunod ng positibong Phase 3 RINGSIDE topline data na nagpapakita ng 84% na pagbaba sa panganib ng pag-unlad o kamatayan kumpara sa placebo. Plano rin ng kumpanya na magsumite ng MAA sa EMA bago matapos ang 2026.

Mahahalagang fact

Na-file: May 12, 2026, 08:05 PM
Kaganapan: Naisumite ang aplikasyon
Direksyon: Positibo
Kumpanya: IMNMImmunome
Asset: varegacestat
Pinagmulan: SEC 8-K
Kumpiyansa: May source

Sipi mula sa source

EX-99.1 2 imnm-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Immunome Reports First Quarter 2026 Financial Results and Provides Business Update May 12, 2026 • New Drug Application (NDA) submitted to the U.S. Food and Drug Administration (FDA) in April 2026 seeking approval of varegacestat for the treatment of adults with desmoid tumors • Detailed Phase 3 RINGSIDE data selected for oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting • Phase 1 study ongoing for IM-1021, with initial lymphoma data expected in 2026 • Investigational New Drug (IND) clearance received in April 2026 for IM-1617, a potential first-in-class solid tumor antibody-drug conjugate (ADC) BOTHELL, Wash. – Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused on developing fi

SEC 8-K