---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-26-026761"
form_type: "8-K"
ticker: "CELC"
cik: "0001603454"
company_name: "Celcuity Inc."
filed_at: "2026-06-02T12:10:25+00:00"
generated_at: "2026-06-02T12:15:29.188266+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Gedatolisib doubles PFS vs alpelisib in PIK3CA mutant HR+/HER2- ABC Phase 3 trial

## Summary
- 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.

## SEC filing metadata
- accession: 0001493152-26-026761
- form_type: 8-K
- ticker: CELC
- cik: 0001603454
- company_name: Celcuity Inc.
- filed_at: 2026-06-02T12:10:25+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1603454/000149315226026761/0001493152-26-026761-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1603454/000149315226026761/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-26-026761
- JSON: https://secwatch.observer/filing/0001493152-26-026761.json
- Plain text: https://secwatch.observer/filing/0001493152-26-026761.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.