---
schema_version: "secwatch.filing_event.v1"
accession: "0001641172-25-021095"
form_type: "8-K"
ticker: "CELC"
cik: "0001603454"
company_name: "Celcuity Inc."
filed_at: "2025-07-28T23:59:59+00:00"
generated_at: "2026-05-18T00:16:30.274955+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.95
calibrated_materiality_score: 0.95
confidence: "high"
source: SEC EDGAR
---

# Celcuity Phase 3 VIKTORIA-1 PIK3CA wild-type: gedatolisib triplet cuts progression/death risk by 76% (HR 0.24)

## Summary
- Gedatolisib triplet (plus palbociclib/fulvestrant) mPFS 9.3 mo vs 2.0 mo for fulvestrant, incremental gain 7.3 mo.
- Gedatolisib doublet (plus fulvestrant) mPFS 7.4 mo vs 2.0 mo, reducing risk by 67% (HR 0.33; p<0.0001).
- Treatment discontinuation due to AEs lower than prior Phase 1b; fewer hyperglycemia/stomatitis events.
- Celcuity expects to submit NDA to FDA for gedatolisib in Q4 2025; mutation cohort topline by end of 2025.
- Efficacy milestones: best HR and mPFS improvement ever reported in any Phase 3 for HR+/HER2- ABC.

## SEC filing metadata
- accession: 0001641172-25-021095
- form_type: 8-K
- ticker: CELC
- cik: 0001603454
- company_name: Celcuity Inc.
- filed_at: 2025-07-28T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.95
- calibrated_materiality_score: 0.95
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1603454/000164117225021095/0001641172-25-021095-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1603454/000164117225021095/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001641172-25-021095
- JSON: https://secwatch.observer/filing/0001641172-25-021095.json
- Plain text: https://secwatch.observer/filing/0001641172-25-021095.txt

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