Celcuity Stock Hits All-Time High On Gedatolisib Progress

(RTTNews) - Shares of Celcuity Inc. (CELC) touched an all-time high of $53.85 in early trading today, building on several eventful months driven by developments surrounding its lead drug candidate, Gedatolisib.

Gedatolisib is a potent, pan-PI3K and mTORC1/2 inhibitor being developed for the treatment of patients with HR+/HER2-advanced breast cancer. Celcuity obtained the rights to this drug candidate through a licensing agreement with Pfizer, signed in April 2021.

A phase III trial evaluating Gedatolisib in combination with fulvestrant, with and without palbociclib, in patients with HR+/HER2-advanced breast cancer who have received prior treatment with a CDK4/6 inhibitor, dubbed VIKTORIA-1, is underway. The study includes two cohorts - the PIK3CA wild-type cohort and the PIK3CA mutant cohort.

The company reported positive topline results from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 clinical trial on Jul.28, 2025, sending the shares soaring over 230% to as high as $46.42 that day. According to the company, this cohort showed an unprecedented reduction in risk of disease progression or death and an incremental improvement in progression-free survival in patients with HR+/HER2- advanced breast cancer.

The PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 trial is enrolling participants, and topline data readout is anticipated by the end of 2025.

Another phase III trial evaluating the efficacy and safety of Gedatolisib in combination with fulvestrant plus a CDK4/6 inhibitor, either ribociclib or palbociclib, in comparison to fulvestrant plus a CDK4/6 inhibitor as a first-line treatment for endocrine therapy-resistant HR+/HER2- advanced breast cancer patients, dubbed VIKTORIA-2, is ongoing. The first patient was dosed in the study last month.

When we alerted readers to CELC on Dec.4, 2024, it was at $12.60. The all-time high of $53.85 reached today reflects a gain of over 300% from our published price.