Celcuity Inc. — Third Quarter 2026 Earnings Summary

Celcuity Inc. announced that its product REVTORPYK (gedatolisib) became commercially available in the United States on September 30, 2026, for treating HR+/HER2- locally advanced or metastatic breast cancer without a PIK3CA mutation. The company reported a net loss of $73.3 million for the third quarter of 2026, with no product revenue recognized during the period as shipments commenced after the quarter ended. Clinical updates included positive Phase 3 VIKTORIA-1 data for both PIK3CA wild-type and mutant cohorts, alongside early-stage results for metastatic castration-resistant prostate cancer. Additionally, Celcuity hired Byron Robinson as Chief Strategy Officer and confirmed that 91% of U.S. commercial and Medicare lives are covered by health plans including REVTORPYK.