Core Insights - Celcuity Inc. has submitted a New Drug Application (NDA) for gedatolisib to the FDA for the treatment of hormone receptor positive, HER2-negative advanced breast cancer, under the Real-Time Oncology Review program, aiming for expedited regulatory review [1][2] - The NDA submission is based on positive clinical results from the Phase 3 VIKTORIA-1 trial, showing significant efficacy improvements with gedatolisib compared to standard treatments [2][3] Company Overview - Celcuity is a clinical-stage biotechnology company focused on developing targeted therapies for various solid tumors, with gedatolisib as its lead candidate [5][6] - Gedatolisib is a multi-target PI3K/AKT/mTOR inhibitor that comprehensively blocks the PAM pathway, differentiating it from single-target inhibitors [3][5] Clinical Trial Results - The gedatolisib-triplet therapy reduced the risk of disease progression or death by 76% compared to fulvestrant, with a median progression-free survival (PFS) of 9.3 months versus 2.0 months, an improvement of 7.3 months [2] - The gedatolisib-doublet therapy reduced the risk of disease progression or death by 67%, with a median PFS of 7.4 months compared to 2.0 months with fulvestrant, an improvement of 5.4 months [2] Regulatory Context - The FDA's Real-Time Oncology Review program aims to streamline the review process for oncology drugs, ensuring timely access to safe and effective treatments [4]