---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-26-033223"
form_type: "8-K"
ticker: "CELC"
cik: "0001603454"
company_name: "Celcuity Inc."
filed_at: "2026-07-14T21:39:43+00:00"
generated_at: "2026-07-15T10:05:34.556015+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# Celcuity receives FDA approval for REVTORPYK (gedatolisib) in HR+/HER2- breast cancer

## Summary
- FDA approved REVTORPYK for HR+/HER2- PIK3CA wild-type advanced/metastatic breast cancer after endocrine therapy.
- Phase 3 VIKTORIA-1: REVTORPYK triplet reduced risk of progression/death by 76% vs fulvestrant (HR=0.24; median PFS 9.3 vs 2.0 months).
- Commercial launch expected late Q3 2026; sNDA for PIK3CA mutated cohort planned Q3 2026.
- REVTORPYK is the first FDA-approved pan-PI3K/mTORC1/2 inhibitor.
- Most common adverse reactions include stomatitis (72% triplet), rash, and hyperglycemia.

## SEC filing metadata
- accession: 0001493152-26-033223
- form_type: 8-K
- ticker: CELC
- cik: 0001603454
- company_name: Celcuity Inc.
- filed_at: 2026-07-14T21:39:43+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/1603454/000149315226033223/0001493152-26-033223-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1603454/000149315226033223/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-26-033223
- JSON: https://secwatch.observer/filing/0001493152-26-033223.json
- Plain text: https://secwatch.observer/filing/0001493152-26-033223.txt

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