Celcuity Q2 Results Highlight Cash Surge
Celcuity(NASDAQ:CELC) reported second quarter 2025 results on Aug. 14, 2025, highlighted by top-line Phase III data for gedatolisib in second-line HR-positive, HER2-negative advanced breast cancer. The company ended the quarter with $455 million in pro forma cash after raising $286.5 million in new financing, and plans to file a New Drug Application (NDA) with the FDA in 2025. Key milestones and strategic updates position Celcuity for a potential solo commercial launch pending regulatory approval.
Gedatolisib demonstrated a median progression-free survival (PFS) of 9.3 months for the triplet regimen and 7.4 months for the doublet in the PIK3CA wild-type cohort of the VICTORIA-1 trial, compared to 2 months for fulvestrant alone. Prior Phase III studies in this post-CDK4/6 population reported only 1.7 to 3.9 months of incremental median PFS, with hazard ratios between 0.55 and 0.73, underscoring the magnitude of Celcuity's results.
This efficacy profile positions gedatolisib as a potential new standard of care, expanding Celcuity's addressable market and competitive advantage in second-line advanced breast cancer.
Source Fool.com
