Celcuity Inc. shares rise 13.07% after-hours after FDA accepted NDA review for gedatolisib in HR+/HER2- advanced breast cancer.

Celcuity Inc. rose 13.07% in after-hours trading, following the news that the U.S. Food and Drug Administration (FDA) agreed to accept its New Drug Application (NDA) for gedatolisib in HR+/HER2- advanced breast cancer for review under the Real-Time Oncology Review (RTOR) program. This program facilitates earlier submission of topline efficacy and safety results, allowing for an earlier start to the FDA’s evaluation of the application. Celcuity is expected to initiate a rolling submission to the FDA of its NDA for gedatolisib in September, based on topline data.