Celcuity Inc. has announced the completion of its New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) for gedatolisib, a treatment for hormone receptor positive (HR+), HER2-negative, PIK3CA wild-type advanced breast cancer. The NDA was submitted under the FDA's Real-Time Oncology Review (RTOR) program, which aims to expedite the review process. Gedatolisib previously received Breakthrough Therapy and Fast Track designations based on promising clinical data from the Phase 3 VIKTORIA-1 trial. The application is currently under regulatory review; no final approval has been granted yet. There is no indication that this submission involves funding or participation from organizations other than Celcuity Inc.