The subset of breast cancer patients that Celcuity would initially target is potentially worth $4 billion to $5 billion, according to Sullivan, and approvals for additional indications would increase that market potential further.
Sullivan hopes to get FDA approval for the first use of the drug in patients by the middle of 2026.
Doctors and analysts who’ve followed the clinical trial process are enthused. “We believe geda[tolisib] to be a blockbuster,” wrote Chase Knickerbocker, an analyst with Craig-Hallum Capital Markets, in a recent note to investors.
Dr. Sara Hurvitz, head of the Division of Hematology and Oncology at the University of Washington’s Department of Medicine and co-principal investigator for the trial said in Celcuity’s press release that results of the Phase III trial “are potentially practice-changing.”