Celcuity reports Q4 loss $0.97/share; FDA grants Priority Review for gedatolisib, PDUFA July 17, 2026

Celcuity Inc.

Net loss Q4 $51.0M ($0.97), FY $177.0M ($3.79); adjusted net loss Q4 $38.4M ($0.73), FY $150.8M ($3.22).
FDA accepted NDA for gedatolisib in HR+/HER2-/PIK3CA WT advanced breast cancer, granted Priority Review; PDUFA goal date July 17, 2026.
Topline results from PIK3CA mutant cohort of Phase 3 VIKTORIA-1 expected in Q2 2026.
Updated efficacy/safety results from PIK3CA WT cohort published in Journal of Clinical Oncology in March 2026.

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