NasdaqCM:CELCBiotechs
Celcuity’s Gedatolisib Data Sharpen Focus On Breast Cancer Commercial Path
Celcuity's lead drug candidate, gedatolisib, produced positive Phase 3 results in the VIKTORIA-1 trial for PIK3CA-mutant HR+/HER2- metastatic breast cancer.
The trial met its primary endpoint and showed a significant improvement in progression-free survival.
Celcuity plans to submit a supplemental NDA to the FDA, with full data scheduled for presentation at ASCO 2026.
The program follows an existing Priority Review for gedatolisib in the wild-type population, with an FDA decision...