“We made significant clinical and regulatory progress in the third quarter,” said Brian Sullivan, CEO and co-founder of Celcuity (CELC). “At the ESMO Congress, we presented potentially practice-changing safety and efficacy results for the gedatolisib regimens from the PIK3CA wild-type cohort of our Phase 3 VIKTORIA-1 trial at a late breaking oral presentation. We remain on track to submit the New Drug Application for gedatolisib later this year based on data from the PIK3CA wild-type cohort. The PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 clinical trial is fully enrolled with topline data expected in late Q1 2026 or during Q2 2026.”
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