---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-25-023897"
form_type: "8-K"
ticker: "CELC"
cik: "0001603454"
company_name: "Celcuity Inc."
filed_at: "2025-11-17T23:59:59+00:00"
generated_at: "2026-05-16T19:15:51.133240+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# Celcuity completes NDA submission to FDA for gedatolisib in HR+/HER2- advanced breast cancer under RTOR program

## Summary
- NDA submitted for gedatolisib in HR+/HER2-, PIK3CA wild-type advanced breast cancer.
- Submitted under FDA's RTOR program; drug previously received Breakthrough Therapy and Fast Track designations.
- Phase 3 VIKTORIA-1: triplet reduced risk of progression/death by 76% (HR 0.24); median PFS 9.3 mo vs 2.0 mo.
- Doublet (gedatolisib + fulvestrant) reduced risk by 67% (HR 0.33); median PFS 7.4 mo vs 2.0 mo.
- CEO Sullivan: 'unprecedented efficacy results and overall safety profile are potentially practice changing.'

## SEC filing metadata
- accession: 0001493152-25-023897
- form_type: 8-K
- ticker: CELC
- cik: 0001603454
- company_name: Celcuity Inc.
- filed_at: 2025-11-17T23:59:59+00:00
- event_type: regulatory
- 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/1603454/000149315225023897/0001493152-25-023897-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1603454/000149315225023897/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-25-023897
- JSON: https://secwatch.observer/filing/0001493152-25-023897.json
- Plain text: https://secwatch.observer/filing/0001493152-25-023897.txt

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