Celcuity Stock Up 677% in 6 Months: What's Behind This Huge Increase?

Core Insights - Celcuity (CELC) has made significant clinical and regulatory progress, submitting a new drug application (NDA) for gedatolisib to the FDA for HR+, HER2- advanced breast cancer, with a decision expected in 2026 [1][8] - Gedatolisib is a multi-target PAM inhibitor that blocks the PAM pathway, distinguishing it from existing single-target inhibitors [2] - The NDA is based on positive data from the phase III VIKTORIA-1 study, showing significant improvements in median progression-free survival (PFS) for gedatolisib compared to fulvestrant [3] Clinical Data - The VIKTORIA-1 study demonstrated that gedatolisib achieved 7.3 months and 5.4 months of incremental PFS improvements over fulvestrant for the triplet and doublet therapies, respectively [3] - These PFS improvements are the highest reported in phase III studies for HR+, HER2- advanced breast cancer patients receiving second-line endocrine therapy [3] Market Potential - There is a significant unmet need for more effective therapies for HR+, HER2- advanced breast cancer patients previously treated with a CDK4/6 inhibitor [4] - Celcuity's efficacy results have led to a stock price increase of 677.4% over six months, significantly outperforming the industry average increase of 21.5% [4] Ongoing Research - Enrollment is complete in the PIK3CA mutant cohort of the VIKTORIA-1 study, with top-line data expected in the first half of 2026 [6] - Additional studies on gedatolisib combinations in breast cancer and prostate cancer are ongoing [6]