NasdaqCM:CELCBiotechs
Celcuity (CELC) Is Up 7.2% After FDA Accepts Gedatolisib NDA for Advanced Breast Cancer Approval
Celcuity Inc. recently announced that the FDA accepted its New Drug Application for gedatolisib in HR+/HER2- advanced breast cancer under the Real-Time Oncology Review program, following positive topline Phase 3 results from the VIKTORIA-1 trial’s PIK3CA wild-type cohort.
The combination of gedatolisib with standard therapies showed unprecedented improvements in progression-free survival and risk reduction in this challenging cancer subtype.
We’ll explore how FDA acceptance and the...