Celcuity is a clinical-stage biotech company with a single drug candidate, gedatolisib, targeting solid tumor cancers — primarily breast and prostate cancer. Gedatolisib is a kinase inhibitor that blocks all four class I PI3K isoforms and both mTOR complexes simultaneously, comprehensively inhibiting the PI3K/AKT/mTOR (PAM) signaling pathway that drives tumor growth. This sets it apart from approved competitors like alpelisib and capivasertib, which each block only a single node in the pathway. Gedatolisib is administered intravenously on a three-weeks-on, one-week-off schedule, which Celcuity argues improves tolerability versus oral PI3K inhibitors and simplifies reimbursement by placing the drug under the medical benefit rather than pharmacy benefit. Celcuity's lead program targets HR+/HER2- advanced breast cancer in patients who have progressed after CDK4/6 therapy. Its Phase 3 VIKTORIA-1 trial showed strong results in PIK3CA wild-type patients — a population where no PAM inhibitor has previously worked — and Celcuity submitted an NDA to the FDA in November 2025 with a PDUFA date of July 2026. Celcuity also has an ongoing Phase 3 first-line breast cancer trial and an early-stage prostate cancer program. Celcuity licenses gedatolisib exclusively from Pfizer, owing up to $335M in milestones and low-to-mid-teens royalties on net sales. The company is pre-revenue, funds operations through equity and debt, and plans to commercialize in the U.S. directly if approved, targeting community oncology practices.