Browsing Tag
gedatolisib
3 posts
Why Celcuity’s FDA priority review for gedatolisib could reset the breast cancer playbook
Celcuity earns FDA priority review for gedatolisib in advanced breast cancer. Find out what the July 2026 PDUFA date means for its market trajectory.
Celcuity moves gedatolisib toward U.S. approval with NDA filing for HR+/HER2- advanced breast cancer patients
Discover how Celcuity’s FDA review for gedatolisib could expand treatment choices for HR+/HER2- PIK3CA wild-type advanced breast cancer patients.
How Celcuity Inc.’s gedatolisib trial results sent its stock soaring 46% in a single morning
Celcuity stock surged 46% after Phase 3 trial data showed strong efficacy for gedatolisib in HR+/HER2- breast cancer. Find out what this means for investors.