secwatch.observer — SEC 8-K summary
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Issuer:     Celcuity Inc. (CELC)
CIK:        0001603454
Form:       8-K
Filed at:   2025-10-20T23:59:59+00:00
Accession:  0001493152-25-018565
Event type: other_material
Sentiment:  positive
Materiality: 0.90
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Phase 3 VIKTORIA-1 data: gedatolisib triplet reduces progression risk by 76% in HR+/HER2- ABC
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- Median PFS 9.3mo for gedatolisib triplet vs 2.0mo for fulvestrant (HR=0.24); incremental 7.3mo improvement.
- ORR 31.5% for triplet vs 1% for fulvestrant; median DOR 17.5mo.
- Rolling NDA submission started under FDA RTOR; completion targeted Q4 2025.
- PIK3CA mutant cohort fully enrolled; topline expected late Q1 2026 or Q2 2026.
- Phase 1b data: median PFS 14.6mo in PIK3CA mutant patients overall, 19.7mo with intermittent dose.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1603454/000149315225018565/0001493152-25-018565-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1603454/000149315225018565/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-25-018565

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