FDA Sets July 17 PDUFA Date for Celcuity's Gedatolisib, Phase 3 Trial Expands
CELC has more than doubled off its 52-week low of $9.51.
Summary
The FDA has set a PDUFA date of July 17, 2026, for Celcuity's New Drug Application (NDA) for gedatolisib, granting it Priority Review. This critical regulatory update provides a firm timeline for a potential approval decision for the drug. Additionally, the company is expanding its Phase 3 VIKTORIA-2 trial for gedatolisib in HR+/HER2- advanced breast cancer to include endocrine-sensitive patients, which broadens the drug's potential market. A patent application for a subcutaneous formulation was also submitted. This news follows positive topline results from the VIKTORIA-1 trial earlier this month and significantly de-risks the commercialization pathway for gedatolisib. The PDUFA date is now the primary near-term catalyst.
At the time of this announcement, CELC was trading at $127.30 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $6B. The 52-week trading range was $9.51 to $151.02. This news item was assessed with positive market sentiment and an importance score of 9 out of 10. Source: Reuters.