Celcuity Announces Updated Results From Randomized, Phase 3 VIKTORIA-1 Trial For Gedatolisib, At 2025 SABCS

• For patients whose time to progression on immediate prior therapy was >18 months, median progression-free survival ("PFS") was 12.4 months with gedatolisib + palbociclib + fulvestrant ("gedatolisib triplet") and 10.0 months with gedatolisib + fulvestrant ("gedatolisib doublet") versus 1.9 months for fulvestrant
   
• For patients enrolled in the U.S., Canada, Western Europe, and Asia Pacific, median PFS was 16.6 months with the gedatolisib triplet and 7.1 months with the gedatolisib doublet versus 1.9 months for fulvestrant
  
   
• Measures to mitigate stomatitis were generally effective; most patients experienced resolution to a lower grade of stomatitis within 2 weeks
   

MINNEAPOLIS, Dec. 11, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced updated results from the randomized, Phase 3 VIKTORIA-1 trial for gedatolisib, a multi-target PI3K/AKT/mTOR ("PAM") inhibitor, in adults with hormone receptor positive ("HR+"), human epidermal growth factor receptor 2 negative ("HER2-"), PIK3CA wild-type ("WT"), advanced breast cancer ("ABC"), following progression on, or after, treatment with a CDK4/6 inhibitor and an aromatase inhibitor. The additional study results were presented in an oral presentation session at the 2025 San Antonio Breast Cancer Symposium ("SABCS") today, Thursday, December 11.