{"schema_version":"secwatch.filing_event.v1","accession":"0001558370-22-018677","form_type":"8-K","ticker":"SNGX","cik":"0000812796","company_name":"SOLIGENIX, INC.","filed_at":"2022-12-15T23:59:59+00:00","discovered_at":"2026-05-14T18:03:53.636890+00:00","generated_at":"2026-06-21T04:27:20.090344+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"Soligenix submits NDA to FDA for HyBryte in cutaneous T-cell lymphoma; targets H2 2023 approval","bullets":["NDA submitted for HyBryte (synthetic hypericin) to treat early stage CTCL, a rare cancer affecting >25,000 US patients.","NDA has FDA orphan drug and fast track designations; company anticipates potential approval in H2 2023.","Company estimates worldwide market for HyBryte in CTCL at over $250 million.","US launch targeted for Q1 2024, contingent upon FDA approval."],"urls":{"canonical":"https://secwatch.observer/filing/0001558370-22-018677","json":"https://secwatch.observer/filing/0001558370-22-018677.json","markdown":"https://secwatch.observer/filing/0001558370-22-018677.md","text":"https://secwatch.observer/filing/0001558370-22-018677.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/812796/000155837022018677/0001558370-22-018677-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/812796/000155837022018677/tmb-20221215x8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-21T04:27:20.090344+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"}