Celcuity Inc. (Nasdaq: CELC) has been notified by the U.S. Food and Drug Administration (FDA) that its Investigational New Drug (IND) submission has been reviewed, and Celcuity can proceed with the clinical development of gedatolisib in combination with Nubeqa® (darolutamide), an approved androgen receptor inhibitor, for the treatment of patients with metastatic castration resistant prostate cancer (mCRPC).
August 22, 2023
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