---
schema_version: "secwatch.filing_event.v1"
accession: "0001558370-25-011625"
form_type: "8-K"
ticker: "SNGX"
cik: "0000812796"
company_name: "SOLIGENIX, INC."
filed_at: "2025-08-18T23:59:59+00:00"
generated_at: "2026-05-17T12:14:07.443439+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# FDA grants Soligenix orphan drug designation for SGX945 in Behçet's Disease

## Summary
- FDA orphan drug designation for dusquetide (SGX945) in Behçet's Disease based on Phase 2a results showing biological efficacy and safety.
- Designation provides 7 years U.S. market exclusivity upon FDA approval, plus NDA fee waiver, tax credits, and clinical trial grants.
- Behçet's Disease affects up to 18,000 in the U.S. and 1 million worldwide; current treatments have significant unmet need.
- CEO notes Phase 2a study demonstrated clinically meaningful improvements in oral aphthous ulcers in Behçet's patients.

## SEC filing metadata
- accession: 0001558370-25-011625
- form_type: 8-K
- ticker: SNGX
- cik: 0000812796
- company_name: SOLIGENIX, INC.
- filed_at: 2025-08-18T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/812796/000155837025011625/0001558370-25-011625-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/812796/000155837025011625/sngx-20250818x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001558370-25-011625
- JSON: https://secwatch.observer/filing/0001558370-25-011625.json
- Plain text: https://secwatch.observer/filing/0001558370-25-011625.txt

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