{"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","discovered_at":"2026-05-14T18:03:22.048858+00:00","generated_at":"2026-06-04T03:08:15.244573+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Soligenix gets EMA agreement on confirmatory Phase 3 design for HyBryte in CTCL","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001558370-24-004663","json":"https://secwatch.observer/filing/0001558370-24-004663.json","markdown":"https://secwatch.observer/filing/0001558370-24-004663.md","text":"https://secwatch.observer/filing/0001558370-24-004663.txt","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"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-04T03:08:15.244573+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"}