Record mula sa primary source

MateryalNaitakda ang petsa ng PDUFA

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
Pinagmulan
SEC 8-K
Kumpiyansa
May source
Kalendaryo
Desisyon ng FDA (PDUFA) · Nob 14, 2026
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

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Ipapakita ng Summit Therapeutics ang Data ng Ivonescimab sa 10 Abstract sa ESMO 2026

Presentasyon sa kumperensyaPress release ng kumpanya
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Binuksan ng Summit Therapeutics ang Phase II SMT112-216 na pagsubok ng mga regimen ng ivonescimab sa 1L advanced ccRCC

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Pagbabago sa trial registryClinicalTrials.gov
Summit: FDA sets Nob 14, 2026 PDUFA for ivonescimab BLA in EGFRm NSCLC | SimianX AI