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Investing.com -- Celcuity Inc. (NASDAQ:CELC) stock surged 9.3% after the clinical-stage biotechnology company announced that the U.S. Food and Drug Administration (FDA) has agreed to accept its New Drug Application (NDA) for gedatolisib in HR+/HER2- advanced breast cancer for review under the Real-Time Oncology Review program.
The RTOR program allows for earlier submission of topline efficacy and safety results prior to a complete application, potentially expediting the FDA’s evaluation process. Celcuity plans to initiate a rolling submission to the FDA in September based on topline data from the PIK3CA wild-type cohort of its Phase 3 VIKTORIA-1 clinical trial, with completion of the NDA submission targeted for 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 submission is supported by positive topline results from the Phase 3 VIKTORIA-1 trial. The gedatolisib-triplet (gedatolisib, fulvestrant and palbociclib) reduced the risk of disease progression or death by 76% compared to fulvestrant alone, with a median progression-free survival (PFS) of 9.3 months versus 2.0 months.
The gedatolisib-doublet (gedatolisib and fulvestrant) demonstrated a 67% reduction in the risk of disease progression or death compared to fulvestrant, with median PFS of 7.4 months versus 2.0 months.
Gedatolisib previously received both Breakthrough Therapy and Fast Track designations from the FDA based on preliminary clinical data, highlighting the need for more effective therapies for patients with HR+, HER2- advanced breast cancer who have received prior treatment with a CDK4/6 inhibitor.
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