Abiopharma

CELCUITY INC. (CELC) Announces Clinical Trial Update CELCUITY INC. (CELC) provided an update on its clinical development programs. Clinical Development Highlights:

• Drug Program: palbociclib
• Diseases/Conditions: oncology
• Clinical Stage: clinical trial, Phase 3
• Update Type: Trial Timeline Adjustment
• Primary Factors: Regulatory Process
• Collaboration: ABC
  • targeting a single component of this pathway.” HR+/HER2- breast cancer is the most common subtype of breast cancer, accounting for approximately 70% of all breast cancers.2 Among this breast cancer subtype, approximately 40% have PIK3CA mutations. “These positive topline results demonstrate the potential for gedatolisib to become a transformative new medicine for the treatment of patients with PIK3CA mutant HR+/HER2-advanced breast cancer,” said Igor Gorbatchevsky, MD, Chief Medical Officer of Celcuity. “When considered alongside previously presented data from the VIKTORIA-1 PIK3CA wild-type cohort, the gedatolisib regimens have now demonstrated the potential to improve the standard of care in the second-line setting regardless of the PIK3CA status of a patient’s tumor.” The FDA has granted Priority Review of Celcuity’s New Drug Application (“NDA”) for gedatolisib in patients with HR+/HER2-/PIK3CA wild-type (“WT”) ABC and assigned a Prescription Drug User Fee Act (“PDUFA”) goal date of July 17, 2026
  • targeting cancers involving the PI3K/AKT/mTOR pathway. Researchers have sought for nearly 20 years to develop a drug that blockades this pathway comprehensively without inducing unacceptable levels of toxicity,” commented Brian Sullivan, Chairman, CEO and co-founder of Celcuity. Mr. Sullivan added, “The implications of these results may extend beyond HR+/HER2- advanced breast cancer patients in the second-line setting, and we are working urgently to explore the development of gedatolisib for additional groups of patients whose cancers involve the PI3K/AKT/mTOR pathway.” Presentation Details Presenting Author: Sara Hurvitz, MD, Senior Vice President, Clinical Research Division, Fred Hutchinson Cancer Center, Professor and Head, Division of Hematology and Oncology, University of Washington, Department of Medicine Title: A randomized, open-label, phase 3 study of gedatolisib + fulvestrant ± palbociclib vs standard of care in HR+/HER2−/PIK3CA-mutant advanced breast cancer (VIKTORIA-1 Study 2) Abstract: LBA1008