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.

item 2.02 item 9.01

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Earnings Releases SEC 8-K Item 2.02 confidence 0.9

Celcuity Inc. reported financial results for the fourth quarter and fiscal year ended December 31, 2025.

Period: the fourth quarter and fiscal year ended December 31, 2025
Result: reported results

Exact text from the filing

On March 25, 2026, Celcuity Inc. (the “Company”) issued a press release regarding the Company’s financial results for the fourth quarter and fiscal year ended December 31, 2025.

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51 earnings releases filed in the last 30 days. Browse all earnings releases →

Celcuity Inc. filing history →

Source: SEC EDGAR

accession 0001493152-26-012668

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