News Related to Celcuity

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Gedatolisib combinations beat alpelisib regimen in PIK3CA-mutant HR-positive breast cancer

May 05, 2026

Topline phase 3 VIKTORIA-1 results showed gedatolisib combinations improved progression-free survival versus alpelisib plus fulvestrant in PIK3CA-mutant HR-positive/HER2-negative advanced breast cancer. Celcuity plans a supplemental FDA filing based on the data.

FDA Accepts Celcuity's NDA for Gedatolisib in Advanced Breast Cancer with July 2026 Goal Date

Nov 17, 2025

The FDA has accepted Celcuity's New Drug Application for gedatolisib in HR+/HER2-/PIK3CA wild-type advanced breast cancer, granting Priority Review with a PDUFA goal date of July 17, 2026.