Celcuity’s Gedatolisib Gains FDA Priority Review With 16.6- vs. 1.9-Month PFS
FDA accepted Celcuity’s NDA for gedatolisib in HR+/HER2-/PIK3CA wild-type advanced breast cancer, granting Priority Review with a PDUFA goal date of July 17, 2026. In the Phase 3 VIKTORIA-1 WT cohort, gedatolisib triplet achieved median progression-free survival of 16.6 months versus 1.9 months for fulvestrant.
1. NDA Acceptance and Review
In January 2026, the FDA accepted Celcuity’s New Drug Application for gedatolisib in HR+/HER2-/PIK3CA wild-type advanced breast cancer, granting Priority Review and assigning a PDUFA goal date of July 17, 2026. Management plans a webcast and conference call to discuss the regulatory progress and next steps.
2. WT Cohort Phase 3 Results
Updated efficacy and safety data from the Phase 3 VIKTORIA-1 wild-type cohort showed the gedatolisib triplet (gedatolisib+fulvestrant+palbociclib) delivered a median progression-free survival of 16.6 months versus 1.9 months for fulvestrant alone (HR=0.14; 95% CI: 0.08-0.28; p<0.0001). Patient-reported well-being measures remained stable over eight treatment cycles, and the triplet demonstrated a median time to definitive deterioration of 23.7 months versus 4.0 months for control.
3. Mutant Cohort and Commercial Launch Plans
Topline results for the PIK3CA mutant cohort of VIKTORIA-1 are expected in Q2 2026, which could inform second-line HR+/HER2- advanced breast cancer treatment standards. Celcuity remains on track to prepare for a potential commercial launch of gedatolisib in Q3 2026 pending FDA approval.
4. Q4 and Full Year 2025 Financials
Total operating expenses rose to $49.2 million in Q4 2025 from $36.4 million a year earlier, driven by higher R&D costs of $37.6 million and increased commercial headcount. Full year 2025 expenses totaled $172.2 million versus $113.3 million in 2024, reflecting clinical trial investments and a development milestone payment under the Pfizer license agreement.