Celcuity Inc. announced that the first patient has been dosed in its Phase 1b/2 study (CELC-G-201) evaluating gedatolisib in combination with Nubeqa® (darolutamide), an approved androgen receptor inhibitor, for the treatment of patients with metastatic castration resistant prostate cancer (mCRPC). Gedatolisib, the company?s lead therapeutic candidate, is a potent, reversible dual inhibitor that selectively targets all Class 1 PI3K isoforms and mTORC1/2. In August 2023, Celcuity announced that it had entered into a clinical trial collaboration and supply agreement with Bayer AG to provide Nubeqa® (darolutamide) to Celcuity at no cost for the Phase 1b/2 trial.