secwatch.observer — SEC 8-K summary
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Issuer:     Celcuity Inc. (CELC)
CIK:        0001603454
Form:       8-K
Filed at:   2026-05-01T23:59:59+00:00
Accession:  0001493152-26-020918
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Celcuity Phase 3 VIKTORIA-1 PIK3CA mutant cohort meets primary endpoint with significant PFS improvement
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- Gedatolisib triplet (plus fulvestrant and palbociclib) showed statistically significant PFS improvement vs alpelisib+fulvestrant.
- Gedatolisib doublet (plus fulvestrant) also achieved statistically significant PFS improvement as secondary endpoint.
- Both regimens were generally well tolerated with manageable safety profiles and no new safety signals.
- Celcuity plans sNDA submission to FDA; detailed results will be presented at ASCO 2026 on June 2.
- FDA previously granted Priority Review for NDA in PIK3CA wild-type cohort with PDUFA date July 17, 2026.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1603454/000149315226020918/0001493152-26-020918-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1603454/000149315226020918/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-26-020918

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