Celcuity Inc. (CELC), a clinical-stage biotechnology company, said on Tuesday that the U.S. Food and Drug Administration has accepted for filing its New Drug Application for gedatolisib in hormone receptor-positive, HER2-negative, PIK3CA wild-type advanced breast cancer.
The FDA granted Priority Review and set a Prescription Drug User Fee Act goal date of July 17, 2026. The NDA was submitted under the agency's Real-Time Oncology Review program, designed to expedite the review process.
The submission is based on data from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 clinical trial. Gedatolisib has previously received Breakthrough Therapy and Fast Track designations.
Celcuity shares were down more than 2% in pre-market trading after closing at $109.96 on Friday, up 1.60%.
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