{"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","discovered_at":"2026-05-14T18:02:46.430269+00:00","generated_at":"2026-05-17T12:14:07.443439+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"FDA grants Soligenix orphan drug designation for SGX945 in Behçet's Disease","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001558370-25-011625","json":"https://secwatch.observer/filing/0001558370-25-011625.json","markdown":"https://secwatch.observer/filing/0001558370-25-011625.md","text":"https://secwatch.observer/filing/0001558370-25-011625.txt","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"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T12:14:07.443439+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}