2026-03-25 20:16:56
Celcuity Inc. Reports Fourth Quarter and Full Year 2025 Financial Results with FDA Priority Review for Gedatolisib
Expected Stock impact: Slightly Positive
Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company, announced its financial results for the fourth quarter and full year ended December 31, 2025. The company reported total operating expenses of $49.2 million for the fourth quarter, up from $36.4 million in the same period last year. For the full year, operating expenses reached $172.2 million compared to $113.3 million in 2024. The net loss for the fourth quarter was $51.0 million, or $0.97 per share, compared to a net loss of $36.7 million, or $0.85 per share, for the same quarter in 2024. The full-year net loss was $177.0 million, or $3.79 per share, compared to a net loss of $111.8 million, or $2.83 per share, in 2024. The company highlighted that the FDA accepted its New Drug Application for gedatolisib and granted Priority Review with a PDUFA goal date of July 17, 2026. This drug targets HR+/HER2-/PIK3CA wild-type advanced breast cancer, and results from the Phase 3 VIKTORIA-1 study are expected to be released in the second quarter of 2026. Management expressed optimism about the potential impact of gedatolisib on treatment standards for advanced breast cancer. The company ended the fiscal year with $441.5 million in cash, cash equivalents, and short-term investments, which is expected to finance operations through 2027. The webcast and conference call to discuss these results is scheduled for March 25, 2026, at 4:30 p.m. EDT.
