Overview

• Topline VIKTORIA-1 results showed the gedatolisib triplet reduced the risk of disease progression or death by 76% and the doublet by 67% versus fulvestrant alone in HR+/HER2– advanced breast cancer patients.
• Median progression-free survival reached 9.3 months with the triplet combination and 7.4 months with the doublet, compared to 2.0 months on fulvestrant alone.
• Celcuity’s shares tripled in early trading after the July 28 data release and settled with a nearly 200% gain, lifting its market value to about $1.5 billion.
• Full data from the PIK3CA wild-type cohort will be presented at a medical conference later this year, with mutation cohort results due by year-end.
• The company plans to submit a New Drug Application for gedatolisib to the FDA in the fourth quarter of 2025.