Celcuity's Gedatolisib Receives FDA Priority Review, PDUFA Set for July 17; Reports $177M Net Loss
Summary
Celcuity Inc. announced that the FDA has granted Priority Review for its New Drug Application (NDA) for gedatolisib, a key development in its path to market. The PDUFA goal date is set for July 17, 2026, providing a clear timeline for a potential approval decision for the advanced breast cancer treatment. This significant regulatory milestone comes as the company reported a net loss of $177.0 million for the full year ended December 31, 2025, an increase from the prior year. Despite the loss, Celcuity ended 2025 with a solid cash position of $441.5 million, providing financial runway. Traders will closely monitor the upcoming PDUFA date and the expected topline results from the PIK3CA mutant cohort of the VIKTORIA-1 study in Q2 2026, as these events are critical for the company's future valuation and commercial prospects.
At the time of this announcement, CELC was trading at $106.01 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $5.1B. The 52-week trading range was $7.58 to $120.32. This news item was assessed with neutral market sentiment and an importance score of 8 out of 10. Source: Wiseek News.