Celcuity Inc.

Celcuity Inc. is a clinical-stage biotechnology company headquartered in Minneapolis, Minnesota, focused on transforming cancer treatment through the development of targeted therapies for multiple solid tumor indications. The company's mission centers on addressing cellular abnormalities that drive tumor growth, particularly those involving the PI3K/AKT/mTOR (PAM) pathway.

Celcuity's lead product candidate is gedatolisib, a potent, pan-PI3K and mTORC1/2 inhibitor designed to comprehensively block the PAM pathway. This investigational drug is being developed for the treatment of various cancers, including hormone receptor-positive (HR+), HER2-negative advanced or metastatic breast cancer, and metastatic castration-resistant prostate cancer. The company also utilizes its proprietary CELsignia diagnostic platform, which analyzes live patient tumor cells to identify specific abnormal cellular processes and match patients with appropriate targeted therapies.

In recent developments, Celcuity announced positive topline results in May 2026 from the PIK3CA mutant cohort of its Phase 3 VIKTORIA-1 clinical trial for gedatolisib in HR+/HER2- advanced breast cancer. The U.S. FDA has granted Priority Review for gedatolisib's New Drug Application (NDA) for PIK3CA wild-type advanced breast cancer, with a Prescription Drug User Fee Act (PDUFA) goal date of July 17, 2026. The company plans to submit a supplemental NDA (sNDA) for the PIK3CA mutant cohort. Led by Co-Founder, Chairman, and CEO Brian Sullivan, Celcuity is actively preparing for the potential commercialization of gedatolisib, which analysts project could address a total addressable market exceeding $5 billion with potential peak annual revenues of $2.5-$3 billion.