Headquartered in Minneapolis, MN Fiscal year ends December NASDAQ: CELC celcuity.com
Celcuity Inc. is a commercial-stage biotechnology company that develops and commercializes targeted therapies for multiple solid tumor indications. Its first FDA-approved product is REVTORPYK (gedatolisib), a pan-PI3K and mTORC1/2 inhibitor that comprehensively blocks the PI3K/AKT/mTOR (PAM) pathway. REVTORPYK was approved in July 2026 and launched in the U.S. on September 30, 2026. It is used with fulvestrant, with or without palbociclib, in adults with HR+/HER2- locally advanced or metastatic breast cancer without a detected PIK3CA mutation, following progression on endocrine therapy in the metastatic setting. Celcuity sells the drug through an oncology sales force targeting strategic accounts and community sites. It holds an exclusive global license for gedatolisib from Pfizer. The company is pursuing label expansion in several areas:
- **PIK3CA-mutant breast cancer:** an sNDA was submitted in Q3 2026 based on the VIKTORIA-1 mutant cohort.
- **First-line HR+/HER2- advanced breast cancer:** the Phase 3 VIKTORIA-2 trial is ongoing.
- **Metastatic castration-resistant prostate cancer:** the Phase 1b/2 CELC-G-201 trial is testing gedatolisib with darolutamide. Updated
Zero revenue is a calendar artifact: REVTORPYK did not ship until September 30, the last day of the quarter, so the entire launch lands in Q4. Demand is already there, with 78% of the top 36 strategic accounts ordering.
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Celcuity Inc. is a commercial-stage biotechnology company that develops and commercializes targeted therapies for multiple solid tumor indications. Its first FDA-approved product is REVTORPYK (gedatolisib), a pan-PI3K and mTORC1/2 inhibitor that comprehensively blocks the PI3K/AKT/mTOR (PAM) pathway.
The Wall Street consensus 12-month price target for CELC is $150.85.
