Celcuity (NASDAQ:CELC) shares rose in premarket trading Tuesday after the U.S. Food and Drug Administration accepted the New Drug Application for gedatolisib, a potential first-in-class therapy for patients with advanced breast cancer.
The FDA has assigned the application Priority Review and set a PDUFA action date of July 17, 2026.
The submission, which aims to treat patients with HR+/HER2- PIK3CA wild-type advanced breast cancer, is being processed under the Real-Time Oncology Review (RTOR) program, a pathway designed to expedite the delivery of safe and effective cancer treatments to patients.
Gedatolisib has already received Breakthrough Therapy and Fast Track designations from the agency.
The application is supported by results from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 trial.
Data showed that a triplet regimen of gedatolisib, fulvestrant, and palbociclib reduced the risk of disease progression or death by 76% compared to fulvestrant alone, achieving a median progression-free survival of 9.3 months versus 2 months for the control arm.
Gedatolisib is a pan-class I PI3K and mTOR inhibitor, designed to more comprehensively block the PAM pathway than existing single-target therapies.
"The acceptance of our NDA for gedatolisib with Priority Review is a significant milestone for Celcuity and, more importantly, for the thousands of patients who currently have limited options after progressing on initial therapies," said Brian Sullivan, Chief Executive Officer of Celcuity.
If approved, gedatolisib would become the first PAM pathway inhibitor specifically indicated for this patient population.