---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-25-018565"
form_type: "8-K"
ticker: "CELC"
cik: "0001603454"
company_name: "Celcuity Inc."
filed_at: "2025-10-20T23:59:59+00:00"
generated_at: "2026-05-17T03:13:53.336839+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# Phase 3 VIKTORIA-1 data: gedatolisib triplet reduces progression risk by 76% in HR+/HER2- ABC

## Summary
- 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.

## SEC filing metadata
- accession: 0001493152-25-018565
- form_type: 8-K
- ticker: CELC
- cik: 0001603454
- company_name: Celcuity Inc.
- filed_at: 2025-10-20T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1603454/000149315225018565/0001493152-25-018565-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1603454/000149315225018565/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-25-018565
- JSON: https://secwatch.observer/filing/0001493152-25-018565.json
- Plain text: https://secwatch.observer/filing/0001493152-25-018565.txt

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