Celcuity Phase 3 VIKTORIA-1 PIK3CA mutant cohort meets primary endpoint with significant PFS improvement

Celcuity Inc.

Gedatolisib triplet (plus fulvestrant and palbociclib) showed statistically significant PFS improvement vs alpelisib+fulvestrant.
Gedatolisib doublet (plus fulvestrant) also achieved statistically significant PFS improvement as secondary endpoint.
Both regimens were generally well tolerated with manageable safety profiles and no new safety signals.
Celcuity plans sNDA submission to FDA; detailed results will be presented at ASCO 2026 on June 2.
FDA previously granted Priority Review for NDA in PIK3CA wild-type cohort with PDUFA date July 17, 2026.

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