Cogent Biosciences to Initiate New Drug Application (NDA) Submission for Bezuclastinib Under Real-Time Oncology Review (RTOR)

PEAK trial first ever study to demonstrate statistical significance over an active comparator in GIST patients, with bezuclastinib plus ...
Managed Healthcare Executive

FDA accepts NDA for gedatolisib, Celcuity’s investigational breast cancer treatment

The FDA has accepted a New Drug Application (NDA) for Celcuity’s gedatolisib in hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2), PIK3CA wild-type advanced ...
Seeking Alpha

Celcuity to Initiate NDA Submission of Gedatolisib in PIK3CA Wild-Type Cohort in HR+/HER2- Advanced Breast Cancer Under FDA’s Real-Time Oncology Review Program

MINNEAPOLIS, Aug. 27, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced the U.S. Food and ...