Celcuity's Gedatolisib Doubles PFS to 11.3 Months in Breast Cancer Trial
CELC has more than doubled off its 52-week low of $10.5 on elevated volume (2.1× avg).
Summary
Celcuity announced highly positive results from its gedatolisib regimens in the PIK3CA-mutant VIKTORIA-1 cohort, demonstrating a doubling of median Progression-Free Survival (PFS) to 11.1-11.3 months compared to 5.6 months for the comparator arm. This translates to a 50% reduction in the risk of progression or death. These detailed results follow the company's May 1st announcement of positive topline data from the trial. The strong efficacy data significantly enhance the drug's commercial prospects and support the planned sNDA submission. The FDA's PDUFA date for gedatolisib is July 17, 2026.
At the time of this announcement, CELC was trading at $92.00 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $6B. The 52-week trading range was $10.50 to $151.02. This news item was assessed with positive market sentiment and an importance score of 9 out of 10. Source: Wiseek News.