---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-349227"
form_type: "8-K"
ticker: "CELC"
cik: "0001603454"
company_name: "Celcuity Inc."
filed_at: "2026-08-13T20:15:17+00:00"
generated_at: "2026-08-13T20:18:00.368774+00:00"
event_type: "earnings"
sentiment: "positive"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# Celcuity Q2 net loss $78.9M; FDA approves REVTORPYK, positive PIK3CA MT data

## Summary
- FDA approved REVTORPYK (gedatolisib) for HR+/HER2- PIK3CA WT advanced breast cancer on July 14, 2026; launch expected late Q3 2026.
- Phase 3 VIKTORIA-1 PIK3CA MT: gedatolisib triplet cut progression/death risk 50% vs alpelisib (HR=0.50, p<0.0001); median PFS 11.1 vs 5.6 months.
- Q2 2026 net loss $78.9M ($1.44/share) vs $45.3M ($1.04) prior year; adjusted net loss $58.7M ($1.07) vs $40.5M ($0.93).
- Completed $575M convertible notes offering, net proceeds $557.2M; used $137M to prepay term loan debt.
- sNDA for PIK3CA MT cohort planned Q3 2026; VIKTORIA-2 expanded to first-line endocrine-sensitive patients.

## SEC filing metadata
- accession: 0001193125-26-349227
- form_type: 8-K
- ticker: CELC
- cik: 0001603454
- company_name: Celcuity Inc.
- filed_at: 2026-08-13T20:15:17+00:00
- event_type: earnings
- sentiment: positive
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 2.02, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1603454/000119312526349227/0001193125-26-349227-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1603454/000119312526349227/celc-20260813.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-349227
- JSON: https://secwatch.observer/filing/0001193125-26-349227.json
- Plain text: https://secwatch.observer/filing/0001193125-26-349227.txt

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