Celcuity Announces FDA Acceptance of New Drug Application for Gedatolisib in HR+/HER2-/PIK3CA Wild-Type Advanced Breast Cancer

Core Viewpoint - The FDA has accepted Celcuity Inc.'s New Drug Application for gedatolisib, granting it Priority Review with a PDUFA goal date of July 17, 2026, for the treatment of HR+/HER2- advanced breast cancer [1][2][3]. Group 1: FDA Review and Application - The New Drug Application (NDA) for gedatolisib was submitted under the FDA's Real-Time Oncology Review (RTOR) program, aimed at expediting regulatory review periods [2]. - Gedatolisib has previously received Breakthrough Therapy and Fast Track designations due to promising preliminary clinical data [2]. - The NDA submission is based on clinical data from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 clinical trial [2]. Group 2: Product Details - Gedatolisib is a multi-target PI3K/AKT/mTOR inhibitor that targets all four Class I PI3K isoforms, mTORC1, and mTORC2, providing comprehensive blockade of the PAM pathway [4]. - The mechanism of action of gedatolisib is differentiated from currently approved single-target inhibitors, allowing for full suppression of the PAM pathway [4]. - Nonclinical studies and early clinical data indicate that gedatolisib demonstrates comparable potency and cytotoxicity in both PIK3CA-mutant and wild-type breast tumor cells [4]. Group 3: Company Overview - Celcuity is a clinical-stage biotechnology company focused on developing targeted therapies for various solid tumor indications, with gedatolisib as its lead candidate [5]. - The company has completed enrollment for the PIK3CA wild-type cohort in the VIKTORIA-1 trial and is currently enrolling patients for the PIK3CA mutant cohort [5]. - A Phase 3 clinical trial, VIKTORIA-2, is ongoing, evaluating gedatolisib in combination with a CDK4/6 inhibitor and fulvestrant as first-line treatment for HR+/HER2- advanced breast cancer [5].