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Gedatolisib Therapy Cuts Advanced Breast Cancer Progression by Up to 76% as Shares Soar

An FDA submission is planned for Q4 2025 based on today’s wild-type cohort findings.

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Overview

  • Triplet regimen combining gedatolisib with fulvestrant and palbociclib reduced risk of disease progression or death by 76% versus fulvestrant alone.
  • Doublet regimen of gedatolisib and fulvestrant cut progression risk by 67% compared to fulvestrant monotherapy.
  • The Phase 3 VIKTORIA-1 trial enrolled HR-positive, HER2-negative, PIK3CA wild-type patients after CDK4/6 inhibitor and aromatase inhibitor therapy.
  • Celcuity’s stock surged more than 200% following the release of the topline PFS data.
  • Full trial results will be presented at an upcoming medical conference and mutant-cohort outcomes are expected by year-end.