Celcuity

CELC

Market cap $4.46B

Celcuity Inc. (CELC) Discusses VIKTORIA-1 Trial Results for PIK3CA Mutant Advanced Breast Cancer and Gedatolisib Efficacy Transcript

Celcuity Inc. (NASDAQ:CELC) on Tuesday reported detailed efficacy and safety findings from the PIK3CA-mutated cohort of its Phase 3 VIKTORIA-1 trial.

Celcuity shares slumped 25% , set for their biggest one-day decline, on Tuesday after its experimental breast cancer treatment extended ​the period of time a patient lives without the disease ‌worsening but underperformed a previous trial.

MINNEAPOLIS, June 02, 2026 (GLOBE NEWSWIRE) --  Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company focused on the development of targeted therapies for the treatment of multiple solid tumor indications, today announced detailed efficacy and safety results from the PIK3CA mutant (“MT”) cohort of the Phase 3 VIKTORIA-1 clinical trial of gedatolisib, an investigational pan-PI3K/mTORC1/2 inhibitor, in adults with hormone receptor positive (“HR+”), human epidermal growth factor receptor 2 negative (“HER2-“), PIK3CA mutated, locally advanced or metastatic breast cancer (“ABC”), following progression on, or after, treatment with a CDK4/6 inhibitor and an aromatase inhibitor. VIKTORIA-1 is the first Phase 3 clinical trial to compare the efficacy of two PI3K/AKT/mTOR (“PAM”) inhibitors in this patient population.

Minneapolis-based Celcuity said Tuesday its three-drug regimen doubled the likelihood of survival for patients with breast cancer.

MINNEAPOLIS, June 01, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company focused on the development of targeted therapies for the treatment of multiple solid tumor indications, today announced it will host a conference call and live webcast to review results from the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 clinical trial on Tuesday, June 2, 2026 at 8:00 a.m. EDT / 7:00 a.m.

MINNEAPOLIS, May 28, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company focused on the development of targeted therapies for the treatment of multiple solid tumor indications, today announced that Brian Sullivan, Chief Executive Officer and Co-founder of Celcuity, will present and be available for one-on-one investor meetings at the following investor conferences:

On Thursday, Celcuity Inc. (NASDAQ:CELC) announced amendments to its Phase 3 VIKTORIA-2 clinical trial evaluating gedatolisib as a first-line treatment for patients with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer.

Celcuity Inc. (CELC) Q1 2026 Earnings Call Transcript

Celcuity NASDAQ: CELC reported a wider first-quarter loss as the biotechnology company increased spending tied to commercial launch preparations and continued development of gedatolisib, its investigational therapy for hormone receptor-positive, HER2-negative advanced breast cancer.