Celcuity Inc's stock soared 5.04% during intraday trading on Thursday, driven by multiple positive regulatory and clinical developments for its lead drug candidate, gedatolisib.

The surge follows news that the U.S. Food and Drug Administration has granted Priority Review to Celcuity's New Drug Application for gedatolisib, setting a Prescription Drug User Fee Act target date of July 17, 2026. Additionally, the company announced the expansion of its Phase 3 VIKTORIA-2 trial to include a separate cohort of endocrine-sensitive patients with HR+/HER2- advanced breast cancer, broadening the potential patient population for the treatment.

These developments come after positive prior study data and discussions with the FDA, which also included a Type B meeting on the amended Phase 3 trial design. Celcuity has further strengthened its intellectual property portfolio by submitting a patent application for a subcutaneous formulation of gedatolisib.