Celcuity Inc. (CELC)’s FDA NDA for Gedatolisib Accepted Under RTOR, Accelerating Review

Core Insights - Celcuity Inc. is recognized as one of the 12 best performing healthcare stocks currently available for investment [1] - The company focuses on developing targeted oncology therapies, particularly for solid tumors like advanced breast cancer, with its lead drug candidate being gedatolisib [2] Company Overview - Celcuity Inc. (NASDAQ:CELC) is a clinical-stage biotechnology firm specializing in targeted therapies for oncology [2] - Gedatolisib targets the PI3K and mTOR pathways, which are crucial in tumor growth and resistance, aiming to enhance outcomes for patients with hormone receptor-positive, HER2-negative advanced breast cancer [2] Regulatory Milestones - In August 2025, the U.S. FDA accepted Celcuity's New Drug Application (NDA) for gedatolisib under the Real-Time Oncology Review (RTOR) program, facilitating a quicker regulatory process [3] - The company initiated its rolling submission in September and anticipates completion by the fourth quarter of 2025 [3] - Strong results from the Phase 3 VIKTORIA-1 trial indicated that gedatolisib significantly reduced disease progression risk and improved progression-free survival in the PIK3CA wild-type cohort [3] Financial Position - To bolster its late-stage development and prepare for commercialization, Celcuity expanded its senior secured credit facility to $500 million [4] - This additional capital enhances the company's financial stability, alleviates liquidity concerns, and ensures resources are available as it moves towards potential FDA approval and market launch [4]