---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-26-020918"
form_type: "8-K"
ticker: "CELC"
cik: "0001603454"
company_name: "Celcuity Inc."
filed_at: "2026-05-01T23:59:59+00:00"
generated_at: "2026-05-15T00:19:08.276382+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Celcuity Phase 3 VIKTORIA-1 PIK3CA mutant cohort meets primary endpoint with significant PFS improvement

## Summary
- Gedatolisib triplet (plus fulvestrant and palbociclib) showed statistically significant PFS improvement vs alpelisib+fulvestrant.
- Gedatolisib doublet (plus fulvestrant) also achieved statistically significant PFS improvement as secondary endpoint.
- Both regimens were generally well tolerated with manageable safety profiles and no new safety signals.
- Celcuity plans sNDA submission to FDA; detailed results will be presented at ASCO 2026 on June 2.
- FDA previously granted Priority Review for NDA in PIK3CA wild-type cohort with PDUFA date July 17, 2026.

## SEC filing metadata
- accession: 0001493152-26-020918
- form_type: 8-K
- ticker: CELC
- cik: 0001603454
- company_name: Celcuity Inc.
- filed_at: 2026-05-01T23:59:59+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/1603454/000149315226020918/0001493152-26-020918-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1603454/000149315226020918/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-26-020918
- JSON: https://secwatch.observer/filing/0001493152-26-020918.json
- Plain text: https://secwatch.observer/filing/0001493152-26-020918.txt

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