Celcuity says Phase 3 VIKTORIA-1 meets primary endpoint in PIK3CA-mutant breast cancer

• Celcuity reported positive topline Phase 3 VIKTORIA-1 results in PIK3CA-mutant HR+/HER2- advanced breast cancer for gedatolisib regimens versus alpelisib regimen.
• Primary analysis showed gedatolisib with fulvestrant, palbociclib delayed disease worsening versus standard regimen.
• Secondary comparison also favored gedatolisib with fulvestrant, supporting benefit without detailing trial metrics.
• Data will be presented June 2, 2026, in late-breaking oral session at ASCO Annual Meeting.
• Celcuity plans to submit results to FDA as supplemental NDA, expanding regulatory strategy alongside ongoing review in PIK3CA wild-type disease with PDUFA goal date July 17, 2026.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Celcuity Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202605011703PRIMZONEFULLFEED9711740) on May 01, 2026, and is solely responsible for the information contained therein.