Summit: FDA sets Nob 14, 2026 PDUFA for ivonescimab BLA in EGFRm NSCLC

FDA accepted Summit’s BLA for ivonescimab plus chemotherapy in EGFR-mutated NSCLC after prior TKI therapy and assigned a PDUFA goal date of November 14, 2026. The filing rests on the global Phase III HARMONi trial; updated OS data showing consistent HR 0.76 in both Western and Asian subgroups were provided to the agency.

Mahahalagang fact

Na-file: Hul 23, 2026, 08:07 PM
Kaganapan: Naitakda ang petsa ng PDUFA
Direksyon: Neutral
Kumpanya: SMMTSummit Therapeutics
Asset: ivonescimab
Pinagmulan: SEC 8-K
Kumpiyansa: May source
Kalendaryo: Desisyon ng FDA (PDUFA) · Nob 14, 2026 · Positibo
Petsa ng PDUFA: Nobyembre 14, 2026
HR ng HARMONI OS: 0.76
HR ng HARMONI-6 OS: 0.66

Sipi mula sa source

EX-99.1 2 a2026_prx0723xq22026earn.htm EX-99.1 a2026_prx0723xq22026earn Summit Therapeutics Reports Financial Results and Operational Progress for the Second Quarter and Six Months Ended June 30, 2026 Consistent Overall Survival Observed in Western, Asian Patients in Updated Analysis from Phase III HARMONi Study in EGFRm NSCLC Post-TKI Setting for Ivonescimab Plus Chemotherapy vs. Chemotherapy Ivonescimab Plus Chemotherapy Achieves Statistically Significant and Clinically Meaningful Overall Survival Benefit in 1L Squamous NSCLC HARMONi-6 Trial Conducted in China, the First Phase III Head-to-Head Clinical Study to Demonstrate Superiority over an Anti-PD-(L)1 Antibody-Containing Regimen HARMONi-3 Global Phase III 1L NSCLC Study: Squamous Cohort Final PFS Analysis Events Expected to Be Reac

SEC 8-K