secwatch.observer — SEC 8-K summary
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Issuer:     Celcuity Inc. (CELC)
CIK:        0001603454
Form:       8-K
Filed at:   2026-03-25T23:59:59+00:00
Accession:  0001493152-26-012668
Event type: earnings
Sentiment:  positive
Materiality: 0.85
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1603454/000149315226012668/0001493152-26-012668-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1603454/000149315226012668/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-26-012668

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer