Celcuity Inc.

Celcuity is a commercial-stage biotechnology company focused on developing and commercializing targeted therapies for the treatment of multiple solid tumor indications. Celcuity’s first FDA-approved product is REVTORPYK™ (gedatolisib), a potent pan-PI3K and mTORC1/2 inhibitor that comprehensively blocks the PI3K/AKT/mTOR (PAM) pathway. Its mechanism of action and pharmacokinetic properties are differentiated from other currently approved and investigational therapies that target PI3Kα, AKT or mTORC1, alone or together. Celcuity’s Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib plus fulvestrant with or without palbociclib in patients with HR+/HER2- ABC, supported FDA approval of REVTORPYK for use in adult patients without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting. Results for the PIK3CA mutant cohort of the VIKTORIA-1 clinical trial have been released.

Current securities

1. 10-Q filingNov 5, 2026
2. Results of Operations and Financial ConditionNov 5, 2026
3. 4 filingOct 5, 2026
4. 3 filingOct 5, 2026
5. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements · Regulation FD DisclosureOct 2, 2026