Celcuity Submits Supplemental NDA for REVTORPYK in PIK3CA-Mutant Breast Cancer

08:59 AM EDT, 08/26/2026 (MT Newswires) -- Celcuity (CELC) said Wednesday it has submitted a supplemental new drug application to the US Food and Drug Administration for REVTORPYKTM, intended to treat patients with a type of breast cancer. REVTORPYK is aimed at patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative, locally advanced or metastatic breast cancer with a PIK3CA mutation, following progression on or after treatment with at least one line of endocrine therapy, the company said. Celcuity said the application is based on results from the Phase 3 VIKTORIA-1 clinical trial, in which REVTORPYK plus fulvestrant and palbociclib reduced the risk of disease progression or death by 50% versus alpelisib plus fulvestrant, while REVTORPYK plus fulvestrant reduced the risk by 49%. Median progression-free survival was 11.1 months and 11.3 months, respectively, compared with 5.6 months for alpelisib plus fulvestrant.