secwatch.observer — SEC 8-K summary
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Issuer:     Celcuity Inc. (CELC)
CIK:        0001603454
Form:       8-K
Filed at:   2025-07-28T23:59:59+00:00
Accession:  0001641172-25-021095
Event type: other_material
Sentiment:  positive
Materiality: 0.95
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Celcuity Phase 3 VIKTORIA-1 PIK3CA wild-type: gedatolisib triplet cuts progression/death risk by 76% (HR 0.24)
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- Gedatolisib triplet (plus palbociclib/fulvestrant) mPFS 9.3 mo vs 2.0 mo for fulvestrant, incremental gain 7.3 mo.
- Gedatolisib doublet (plus fulvestrant) mPFS 7.4 mo vs 2.0 mo, reducing risk by 67% (HR 0.33; p<0.0001).
- Treatment discontinuation due to AEs lower than prior Phase 1b; fewer hyperglycemia/stomatitis events.
- Celcuity expects to submit NDA to FDA for gedatolisib in Q4 2025; mutation cohort topline by end of 2025.
- Efficacy milestones: best HR and mPFS improvement ever reported in any Phase 3 for HR+/HER2- ABC.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1603454/000164117225021095/0001641172-25-021095-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1603454/000164117225021095/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001641172-25-021095

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