---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-365975"
form_type: "8-K"
ticker: "CELC"
cik: "0001603454"
company_name: "Celcuity Inc."
filed_at: "2026-08-26T12:35:14+00:00"
generated_at: "2026-08-26T12:40:07.114613+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Celcuity files sNDA for REVTORPYK in PIK3CA-mutant advanced breast cancer

## Summary
- sNDA seeks FDA approval for REVTORPYK (gedatolisib) in HR+/HER2- ABC with PIK3CA mutation after ≥1 endocrine therapy.
- Phase 3 VIKTORIA-1: triplet cut progression/death risk by 50% vs alpelisib+fulvestrant (HR=0.50, p<0.0001); median PFS 11.1 vs 5.6 months.
- Doublet: HR=0.51 (p=0.0013), median PFS 11.3 vs 5.6 months; ORR 49% (triplet) and 36% (doublet).
- If approved, first therapy for PIK3CA-mutant ABC inhibiting all class I PI3K isoforms and mTORC1/C2.
- FDA approved REVTORPYK for PIK3CA wild-type ABC on July 14, 2026; this submission expands to mutant population.

## SEC filing metadata
- accession: 0001193125-26-365975
- form_type: 8-K
- ticker: CELC
- cik: 0001603454
- company_name: Celcuity Inc.
- filed_at: 2026-08-26T12:35:14+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1603454/000119312526365975/0001193125-26-365975-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1603454/000119312526365975/celc-20260826.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-365975
- JSON: https://secwatch.observer/filing/0001193125-26-365975.json
- Plain text: https://secwatch.observer/filing/0001193125-26-365975.txt

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