What's Going On With Celcuity Stock On Tuesday?

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

Gedatolisib Outperformed Comparator Regimen

According to the company, the gedatolisib-triplet regimen delivered a statistically significant improvement in progression-free survival compared with alpelisib plus fulvestrant.

Patients receiving the triplet therapy achieved a median progression-free survival of 11.1 months versus 5.6 months for the comparator arm.

Celcuity said the treatment reduced the risk of disease progression or death by 50%, based on a hazard ratio of 0.50.

The objective response rate reached 48.9%, compared with 26.0% for alpelisib plus fulvestrant.

Median duration of response was 15.7 months for the gedatolisib-triplet versus 7.5 months for the comparator regimen.

The company also reported encouraging results for the gedatolisib-doublet regimen. Median progression-free survival was 11.3 months, more than double the 5.6 months reported for alpelisib plus fulvestrant.

The doublet achieved an objective response rate of 35.7% and a median duration of response of 24.2 months.

Trial Establishes Several Development Milestones

Celcuity said VIKTORIA-1 became the first Phase 3 study to demonstrate superiority of one PI3K/AKT/mTOR pathway inhibitor over another in this patient population.

The company added that the 11.1-month median progression-free survival reported for the gedatolisib-triplet is the highest reported in a Phase 3 study evaluating a second-line endocrine therapy-containing regimen for HR-positive, HER2-negative advanced breast cancer.

It also said the 48.9% objective response rate is the highest reported in a Phase 3 trial of a second-line endocrine therapy-based regimen in this setting.

Celcuity Regulatory Filings Planned

While overall survival data remain immature, Celcuity said both the gedatolisib-triplet and doublet arms showed promising trends on the key secondary endpoint.

The company plans to submit the VIKTORIA-1 data to the U.S. Food and Drug Administration as part of a supplemental New Drug Application and intends to seek approvals from additional regulatory agencies afterward.

Separately, the FDA has granted Priority Review to Celcuity's New Drug Application for gedatolisib in patients with HR-positive, HER2-negative, PIK3CA wild-type advanced breast cancer, with a Prescription Drug User Fee Act target action date of July 17, 2026.

CELC Price Action: Celcuity shares were down 25.03% at $92.18 at the time of publication on Tuesday, according to Benzinga Pro data.

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