Celcuity Stock Hits All-Time High on Gedatolisib Trial Success

Celcuity's stock has reached an all-time high of $53.85, driven by positive topline results from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 clinical trial for its lead drug candidate, Gedatolisib. The trial showed a reduction in risk of disease progression or death and an incremental improvement in progression-free survival for HR+/HER2-advanced breast cancer patients. The PIK3CA mutant cohort is enrolling participants, with topline data expected by year-end. Another phase III trial, VIKTORIA-2, is also ongoing.

Celcuity Inc. (CELC) saw its stock price hit an all-time high of $53.85 today, fueled by the positive topline results from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 clinical trial. The trial, which evaluated Gedatolisib in combination with fulvestrant and palbociclib for HR+/HER2-advanced breast cancer, demonstrated a significant reduction in risk of disease progression or death and an incremental improvement in progression-free survival [1].

The PIK3CA wild-type cohort showed a 76% reduction in disease progression risk with the gedatolisib triplet therapy and a 67% reduction with the doublet therapy. This represents a potential paradigm shift in HR+/HER2- advanced breast cancer treatment, with hazard ratios (HR) of 0.24 and 0.33, respectively [2].

The PIK3CA mutant cohort is currently enrolling participants, with topline data expected by the end of 2025. Additionally, another phase III trial, VIKTORIA-2, is ongoing, evaluating the efficacy and safety of Gedatolisib in combination with fulvestrant and CDK4/6 inhibitors as a first-line treatment for endocrine therapy-resistant HR+/HER2- advanced breast cancer patients.

Celcuity's stock has seen a substantial increase, reflecting a gain of over 300% from its price of $12.60 in December 2024. The company's strong financial position, with a proforma cash position of $455 million, provides flexibility for the critical transition from development to commercialization [2].

References:
[1] https://www.rttnews.com/3566617/celcuity-stock-hits-all-time-high-on-gedatolisib-progress.aspx
[2] https://www.stocktitan.net/news/CELC/celcuity-inc-reports-second-quarter-2025-financial-results-and-kuvlwcp6udhp.html