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. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced the U....
What regulatory, clinical‑data, and competitive risks could delay approval or limit commercial uptake of gedatolisib, and how might those risks be priced into the stock?
What is the projected market size and revenue potential for gedatolisib in the PIK3CA wild‑type HR+/HER2‑ advanced breast cancer niche compared to existing PI3K inhibitors and endocrine therapies?
How will the FDA’s acceptance of the RTOR pathway and the anticipated September NDA submission influence Celcuity’s short‑term stock volatility and trading volume?
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