Celcuity Shares Surge to Record High on Accelerated FDA Review

Celcuity Inc. saw its stock price climb to an unprecedented peak of $55.58 on Friday, cementing a remarkable year-to-date gain of 264.54%. This powerful rally was ignited by the announcement that the U.S. Food and Drug Administration (FDA) has granted an accelerated review pathway for the company’s investigational cancer drug, Gedatolisib.

The catalyst for this surge came on August 27th, when the regulatory agency accepted the New Drug Application for Gedatolisib into its Real-Time Oncology Review (RTOR) program. This prestigious designation is reserved for therapies demonstrating substantial clinical improvements over existing treatment options.

Supporting this regulatory advancement were compelling results from the pivotal Phase 3 VIKTORIA-1 trial. The data revealed that Gedatolisib administered as a triple therapy achieved a dramatic 76% reduction in the risk of disease progression Read more...