Celcuity Soars On Breast Cancer Trial Results, To Seek FDA Approval For Gedatolisib In Q4

(RTTNews) - Celcuity Inc. (CELC) has announced positive topline results from the PIK3CA wild-type cohort of its Phase 3 VIKTORIA-1 clinical trial, and shares are up over 200% at $44.

The Phase 3 VIKTORIA-1 trial is evaluating the company's lead drug candidate, Gedatolisib, in combination with fulvestrant, with and without palbociclib, in HR+/HER2- advanced breast cancer patients who have received prior treatment with a CDK4/6 inhibitor. The study includes two cohorts - the PIK3CA wild-type cohort and the PIK3CA mutant cohort.

The results from the PIK3CA wild-type cohort of the VIKTORIA-1 trial, reported today, show that the combination of Gedatolisib, palbociclib, and fulvestrant, referred to as the Gedatolisib triplet, significantly improved progression-free survival (PFS) in patients compared to fulvestrant alone. The triplet therapy reduced the risk of disease progression or death by 76%. The median PFS was 9.3 months for the triplet therapy compared to 2.0 months with fulvestrant alone.

Similarly, the Gedatolisib doublet (gedatolisib plus fulvestrant) also demonstrated a strong clinical benefit, reducing the risk of progression or death by 67% versus fulvestrant. The median PFS was 7.4 months with the doublet, compared to 2.0 months with fulvestrant alone.

According to the company, the 7.3-month and 5.4-month increases in median progression-free survival (PFS) seen with the gedatolisib triplet and doublet, respectively, compared to fulvestrant, are higher than have ever been reported by any Phase 3 trial for patients with HR+/HER2- advanced breast cancer who have received two or more lines of therapy.

Celcuity expects to submit a New Drug Application for Gedatolisib to the FDA in the fourth quarter of 2025.

The company expects to report topline data for the VIKTORIA-1 PIK3CA mutation cohort by the end of this year.

When we alerted readers to CELC on Dec.4, 2024, it was trading at $13.90.

CELC has traded in a range of $7.57 to $18.87 in the last 1 year. The stock closed Friday's trading at $13.77, down 1.99%.