secwatch.observer — SEC 8-K summary
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Issuer:     Celcuity Inc. (CELC)
CIK:        0001603454
Form:       8-K
Filed at:   2026-06-02T12:10:25+00:00
Accession:  0001493152-26-026761
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Gedatolisib doubles PFS vs alpelisib in PIK3CA mutant HR+/HER2- ABC Phase 3 trial
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- Gedatolisib-triplet reduced risk of progression or death by 50% (HR=0.50; p<0.0001); median PFS 11.1 vs 5.6 months.
- ORR 48.9% for triplet vs 26.0%; median DOR 15.7 vs 7.5 months for alpelisib+fulvestrant.
- Grade 3+ TRAEs: neutropenia 58.8% (triplet) vs 0.7%; discontinuation rate 2.6% vs 7.1%.
- Company plans sNDA submission following positive PIK3CA MT cohort; PDUFA for NDA in WT cohort July 17, 2026.
- Commercial launch expected in Q3 2026 pending FDA approval.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1603454/000149315226026761/0001493152-26-026761-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1603454/000149315226026761/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-26-026761

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