secwatch.observer — SEC 8-K summary
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Issuer:     Celcuity Inc. (CELC)
CIK:        0001603454
Form:       8-K
Filed at:   2026-05-14T20:05:21+00:00
Accession:  0001493152-26-023065
Event type: earnings
Sentiment:  positive
Materiality: 0.85
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Celcuity reports Q1 net loss $52.8M; VIKTORIA-1 hits primary endpoint in PIK3CA mutant
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- Net loss $52.8M ($0.97/share) vs $37.0M ($0.86/share) in Q1 2025; non-GAAP adjusted net loss $46.8M ($0.86).
- VIKTORIA-1 PIK3CA mutant cohort: gedatolisib triplet and doublet both achieved statistically significant PFS improvement vs alpelisib+fulvestrant.
- Detailed VIKTORIA-1 data to be presented at ASCO LBA oral session on June 2, 2026; sNDA submission planned for Q3 2026.
- NDA for gedatolisib in PIK3CA wild-type accepted with Priority Review; PDUFA date July 17, 2026.
- VIKTORIA-2 expanded: Study 2 (~740 patients) evaluating gedatolisib as first-line in endocrine-sensitive HR+/HER2- advanced breast cancer.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1603454/000149315226023065/0001493152-26-023065-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1603454/000149315226023065/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-26-023065

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