Clinical trial results for Gedatolisib in treating breast cancer have proven successful, propelling Celcuity to aim for FDA approval for the drug by the end of Q4.
In a groundbreaking development, Celcuity Inc.'s lead drug candidate, Gedatolisib, has demonstrated unprecedented progression-free survival (PFS) benefits in the treatment of HR+/HER2- advanced breast cancer patients with PIK3CA wild-type tumors.
The Phase 3 VIKTORIA-1 clinical trial, which evaluates 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, has yielded promising results.
The trial includes two cohorts: the PIK3CA wild-type cohort and the PIK3CA mutant cohort. The results from the PIK3CA wild-type cohort show that the combination of Gedatolisib, palbociclib, and fulvestrant (the Gedatolisib triplet) significantly improved PFS in patients compared to fulvestrant alone.
The Gedatolisib triplet reduced the risk of disease progression or death by 76%, with a median PFS of 9.3 months compared to 2.0 months with fulvestrant alone. This is a remarkable improvement, as the 7.3-month increase in median PFS seen with the Gedatolisib triplet is 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.
The Gedatolisib doublet (gedatolisib plus fulvestrant) also demonstrated a strong clinical benefit, reducing the risk of progression or death by 67%.
Celcuity plans to submit a New Drug Application (NDA) to the FDA in the fourth quarter of 2025, following the presentation of the full VIKTORIA-1 data later in 2025. The stock price of Celcuity Inc. (CELC) has increased over 200% from its previous level to $44 following the positive topline results from the PIK3CA wild-type cohort of its Phase 3 VIKTORIA-1 clinical trial.
The company expects to report topline data for the VIKTORIA-1 PIK3CA mutation cohort by the end of this year. Both regimens demonstrated a favorable safety and tolerability profile with lower treatment discontinuation rates and fewer adverse events like hyperglycemia and stomatitis than previous trials.
Gedatolisib is positioned as a potentially practice-changing treatment for this patient population, especially those whose disease has progressed on or after CDK4/6 inhibitor therapy, addressing a significant unmet need with strong efficacy and manageable safety shown in recent pivotal Phase 3 data.
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[1] Celcuity Inc. Press Release, July 2025. [2] Celcuity Inc. Press Release, July 2025. [3] Celcuity Inc. Press Release, July 2025. [4] Celcuity Inc. Press Release, July 2025. [5] Celcuity Inc. Press Release, July 2025.
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On Dec. 4, 2024, CELC was trading at $13.90. In the last 1 year, CELC's stock has traded in a range of $7.57 to $18.87.
- The promising results from Celcuity Inc.'s Phase 3 VIKTORIA-1 clinical trial indicate that their lead drug candidate, Gedatolisib, may have significant implications in the field of health and wellness, particularly for individuals dealing with breast-cancer.
- The stock price of Celcuity Inc. (CELC) has increased notably following the positive topline results from the PIK3CA wild-type cohort of its Phase 3 VIKTORIA-1 clinical trial, demonstrating potential potential for gains in the investment world.
- The FDA could soon see a New Drug Application (NDA) from Celcuity Inc., as the company plans to submit it in the fourth quarter of 2025, following the presentation of full VIKTORIA-1 data.
- Gedatolisib, if approved, may address a significant unmet need in medical-conditions, such as breast-cancer, especially for patients who have progressed on or after CDK4/6 inhibitor therapy.
