Celcuity Inc

Celcuity Inc. is a biotechnology company focused on developing and commercializing targeted therapies for the treatment of multiple solid tumor indications. Its first FDA-approved product is REVTORPYK (gedatolisib), a potent pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the PAM pathway. REVTORPYK is indicated in combination with fulvestrant, with or without palbociclib, for the treatment of adult patients with HR+/HER2- locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting. The company is conducting the Phase 3 VIKTORIA-1 trial (PIK3CA mutant cohort results supporting a planned sNDA), the Phase 3 VIKTORIA-2 trial evaluating gedatolisib as first-line treatment in both endocrine-resistant and endocrine-sensitive HR+/HER2- advanced breast cancer, and a Phase 1b/2 trial evaluating gedatolisib in combination with darolutamide in metastatic castration-resistant prostate cancer. Celcuity is also developing a subcutaneous formulation of gedatolisib to support potential future indications requiring extended treatment durations. Updated Aug 13, 2026