---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-408353"
form_type: "8-K"
ticker: "CELC"
cik: "0001603454"
company_name: "Celcuity Inc."
filed_at: "2026-09-30T12:05:14+00:00"
generated_at: "2026-10-12T13:58:07.638541+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Celcuity's REVTORPYK (gedatolisib) now commercially available in US for HR+/HER2- advanced breast cancer

## Summary
- FDA approved REVTORPYK on July 14, 2026 as a triplet with palbociclib and fulvestrant, and as a doublet with fulvestrant, for HR+/HER2- ABC without a PIK3CA mutation.
- In the Phase 3 VIKTORIA-1 PIK3CA wild-type cohort, the REVTORPYK triplet and doublet cut risk of disease progression or death by 76% and 67% versus fulvestrant.
- Celcuity launched REVTORPYK Support Services offering insurance coverage, Copay Assistance and Patient Assistance help; contact 877-423-5284 or www.revtorpykhcp.com.
- A supplemental NDA was submitted to the FDA in August for REVTORPYK in HR+/HER2-, PIK3CA-mutated advanced breast cancer based on Study 2 of VIKTORIA-1.

## SEC filing metadata
- accession: 0001193125-26-408353
- form_type: 8-K
- ticker: CELC
- cik: 0001603454
- company_name: Celcuity Inc.
- filed_at: 2026-09-30T12:05:14+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1603454/000119312526408353/0001193125-26-408353-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1603454/000119312526408353/celc-20260930.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-408353
- JSON: https://secwatch.observer/filing/0001193125-26-408353.json
- Plain text: https://secwatch.observer/filing/0001193125-26-408353.txt

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