Upcoming Clinical Data Readouts
Celcuity expects to report topline data from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 trial in Q3 2025 and from the PIK3CA mutated patient cohort in Q4 2025, indicating significant progress in their clinical trials.
Potential Revenue from Gedatolisib
If gedatolisib receives FDA approval for both PIK3CA wild-type and mutant populations, the estimated peak revenue potential for the second-line indication could exceed $2 billion with 40% market penetration.
Advancements in VIKTORIA-2 Trial
Significant progress in activating trial sites for the Phase 3 first-line VIKTORIA-2 trial, with nearly 200 sites qualified across multiple regions.
Endometrial Cancer Collaboration
Celcuity announced a collaboration with Dana Farber Cancer Institute and Massachusetts General Hospital to evaluate gedatolisib in combination with abemaciclib and letrozole in patients with endometrial cancer.