---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-26-049787"
form_type: "8-K"
ticker: "SNGX"
cik: "0000812796"
company_name: "SOLIGENIX, INC."
filed_at: "2026-04-28T23:59:59+00:00"
generated_at: "2026-05-15T03:29:19.156078+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# Soligenix Phase 3 FLASH2 trial of HyBryte for CTCL halted for futility

## Summary
- Data Monitoring Committee interim efficacy analysis recommended halt; HyBryte failed to show benefit at 18 weeks.
- Company reports ~$5.9M cash; evaluating strategic options including M&A or advancing dusquetide for Behçet's Disease.
- HyBryte previously showed statistically significant lesion reduction in Phase 3 FLASH study at 6 weeks, but not replicated in FLASH2.
- Soligenix plans further data analysis to identify patient subsets; will discuss with FDA and EMA if warranted.

## SEC filing metadata
- accession: 0001104659-26-049787
- form_type: 8-K
- ticker: SNGX
- cik: 0000812796
- company_name: SOLIGENIX, INC.
- filed_at: 2026-04-28T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/812796/000110465926049787/0001104659-26-049787-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/812796/000110465926049787/sngx-20260428x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-26-049787
- JSON: https://secwatch.observer/filing/0001104659-26-049787.json
- Plain text: https://secwatch.observer/filing/0001104659-26-049787.txt

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