NasdaqCM:CELCBiotechs
Celcuity’s Priority Review Puts Gedatolisib And Investor Trade Offs In Focus
Celcuity (NasdaqCM:CELC) received FDA Priority Review for its New Drug Application for gedatolisib in advanced breast cancer.
The Priority Review follows strong Phase 3 efficacy results from the VIKTORIA-1 trial in HR-positive, HER2-negative breast cancer.
An additional Phase 3 readout for the PIK3CA mutant cohort is upcoming and could further influence treatment standards for this patient group.
Celcuity focuses on targeted therapies for cancer, with gedatolisib as a key asset in its...