Celcuity stock soars after breakthrough breast cancer drug trial results
Investing.com -- Celcuity Inc. (NASDAQ:CELC) stock surged over 100% following the announcement of positive Phase 3 trial results for its breast cancer drug gedatolisib, which showed unprecedented efficacy in treating hormone receptor-positive, HER2-negative advanced breast cancer.
The company reported that its gedatolisib triplet therapy (gedatolisib plus palbociclib and fulvestrant) reduced the risk of disease progression or death by 76% compared to fulvestrant alone in patients with PIK3CA wild-type advanced breast cancer. Additionally, the gedatolisib doublet therapy (gedatolisib plus fulvestrant) reduced the risk by 67%.
These results represent historic milestones in breast cancer treatment, with hazard ratios more favorable than any previously reported in Phase 3 trials for this type of cancer. The gedatolisib triplet showed a 7.3-month improvement in median progression-free survival over fulvestrant alone, while the doublet demonstrated a 5.4-month improvement.
"The topline data for both gedatolisib regimens from VIKTORIA-1 are potentially practice-changing. To my knowledge, we have not seen Phase 3 results in patients with HR-positive, HER2-negative advanced breast cancer before where there was a quadrupling of the likelihood of survival without disease progression relative to the study control," said Dr. Sara Hurvitz, co-principal investigator for the trial and Senior Vice President at Fred Hutchinson Cancer Center.
The drug also demonstrated a favorable safety profile, with lower treatment discontinuation rates due to adverse events than observed in previous trials or with currently approved drug combinations.
Celcuity plans to submit a New Drug Application to the FDA in the fourth quarter of 2025, with full data from the PIK3CA wild-type cohort to be presented at an upcoming medical conference later this year. Topline data for the PIK3CA mutation cohort is expected by the end of 2025.
Gedatolisib is a multi-target PAM inhibitor that blocks all four class I PI3K isoforms and mTOR complexes, providing comprehensive pathway inhibition that differentiates it from currently approved single-target inhibitors.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.
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