Celcuity Inc. (NASDAQ:CELC) stock jumped 9.3% following the announcement that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for gedatolisib in HR+/HER2- advanced breast cancer. The submission will be reviewed under the FDA’s Real-Time Oncology Review (RTOR) program.
The RTOR initiative allows companies to submit key efficacy and safety data ahead of a complete application, potentially accelerating the FDA’s evaluation process. Celcuity intends to start a rolling submission in September based on topline results from the PIK3CA wild-type cohort of its Phase 3 VIKTORIA-1 clinical trial, aiming to complete the NDA submission by the fourth quarter of 2025.
“On the heels of announcing positive pivotal data last month, we are pleased that the FDA agreed to review our NDA application for gedatolisib under the RTOR program,” said Brian Sullivan, CEO and co-founder of Celcuity.
The NDA is backed by strong topline results from the Phase 3 VIKTORIA-1 trial. The gedatolisib-triplet regimen (gedatolisib, fulvestrant, and palbociclib) lowered the risk of disease progression or death by 76% versus fulvestrant alone, with a median progression-free survival (PFS) of 9.3 months compared to 2.0 months.
The gedatolisib-doublet (gedatolisib and fulvestrant) showed a 67% reduction in risk versus fulvestrant alone, achieving a median PFS of 7.4 months compared to 2.0 months.
Gedatolisib had previously received both Breakthrough Therapy and Fast Track designations from the FDA based on preliminary clinical data, emphasizing the need for more effective treatment options for patients with HR+, HER2- advanced breast cancer who have already been treated with a CDK4/6 inhibitor.
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