secwatch.observer — SEC 8-K summary
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Issuer:     Celcuity Inc. (CELC)
CIK:        0001603454
Form:       8-K
Filed at:   2025-11-17T23:59:59+00:00
Accession:  0001493152-25-023897
Event type: regulatory
Sentiment:  positive
Materiality: 0.90
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Celcuity completes NDA submission to FDA for gedatolisib in HR+/HER2- advanced breast cancer under RTOR program
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- NDA submitted for gedatolisib in HR+/HER2-, PIK3CA wild-type advanced breast cancer.
- Submitted under FDA's RTOR program; drug previously received Breakthrough Therapy and Fast Track designations.
- Phase 3 VIKTORIA-1: triplet reduced risk of progression/death by 76% (HR 0.24); median PFS 9.3 mo vs 2.0 mo.
- Doublet (gedatolisib + fulvestrant) reduced risk by 67% (HR 0.33); median PFS 7.4 mo vs 2.0 mo.
- CEO Sullivan: 'unprecedented efficacy results and overall safety profile are potentially practice changing.'

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1603454/000149315225023897/0001493152-25-023897-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1603454/000149315225023897/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-25-023897

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