---
schema_version: "secwatch.filing_event.v1"
accession: "0001558370-24-004663"
form_type: "8-K"
ticker: "SNGX"
cik: "0000812796"
company_name: "SOLIGENIX, INC."
filed_at: "2024-04-03T23:59:59+00:00"
generated_at: "2026-06-04T03:08:15.244573+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Soligenix gets EMA agreement on confirmatory Phase 3 design for HyBryte in CTCL

## Summary
- EMA agreed on key design for FLASH2: double-blind, placebo-controlled, 18-week continuous treatment.
- Study to enroll ~80 early-stage CTCL patients in US and Europe; enrollment targeted by end of 2024.
- Primary endpoint: ≥50% reduction in mCAILS score at Week 18; top-line results expected H2 2026.
- FLASH2 replicates first Phase 3 design but extends continuous treatment without breaks.
- Discussions with FDA on US development path remain ongoing; company prioritizes EMA pathway.

## SEC filing metadata
- accession: 0001558370-24-004663
- form_type: 8-K
- ticker: SNGX
- cik: 0000812796
- company_name: SOLIGENIX, INC.
- filed_at: 2024-04-03T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/812796/000155837024004663/0001558370-24-004663-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/812796/000155837024004663/sngx-20240403x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001558370-24-004663
- JSON: https://secwatch.observer/filing/0001558370-24-004663.json
- Plain text: https://secwatch.observer/filing/0001558370-24-004663.txt

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