---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-26-012668"
form_type: "8-K"
ticker: "CELC"
cik: "0001603454"
company_name: "Celcuity Inc."
filed_at: "2026-03-25T23:59:59+00:00"
generated_at: "2026-05-15T09:00:46.883962+00:00"
event_type: "earnings"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Celcuity reports Q4 loss $0.97/share; FDA grants Priority Review for gedatolisib, PDUFA July 17, 2026

## Summary
- Net loss Q4 $51.0M ($0.97), FY $177.0M ($3.79); adjusted net loss Q4 $38.4M ($0.73), FY $150.8M ($3.22).
- FDA accepted NDA for gedatolisib in HR+/HER2-/PIK3CA WT advanced breast cancer, granted Priority Review; PDUFA goal date July 17, 2026.
- Topline results from PIK3CA mutant cohort of Phase 3 VIKTORIA-1 expected in Q2 2026.
- Updated efficacy/safety results from PIK3CA WT cohort published in Journal of Clinical Oncology in March 2026.

## SEC filing metadata
- accession: 0001493152-26-012668
- form_type: 8-K
- ticker: CELC
- cik: 0001603454
- company_name: Celcuity Inc.
- filed_at: 2026-03-25T23:59:59+00:00
- event_type: earnings
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 2.02, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1603454/000149315226012668/0001493152-26-012668-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1603454/000149315226012668/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-26-012668
- JSON: https://secwatch.observer/filing/0001493152-26-012668.json
- Plain text: https://secwatch.observer/filing/0001493152-26-012668.txt

## Key facts
- Earnings Releases
  Celcuity Inc. reported financial results for the fourth quarter and fiscal year ended December 31, 2025.
  - Period: the fourth quarter and fiscal year ended December 31, 2025
  - Result: reported results
  source text: On March 25, 2026, Celcuity Inc. (the “Company”) issued a press release regarding the Company’s financial results for the fourth quarter and fiscal year ended December 31, 2025.
  evidence_url: https://www.sec.gov/Archives/edgar/data/1603454/000149315226012668/0001493152-26-012668-index.htm

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