{"schema_version":"secwatch.filing_event.v1","accession":"0001558370-23-001226","form_type":"8-K","ticker":"SNGX","cik":"0000812796","company_name":"SOLIGENIX, INC.","filed_at":"2023-02-14T23:59:59+00:00","discovered_at":"2026-05-14T18:03:48.159591+00:00","generated_at":"2026-06-19T14:56:44.301033+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"Soligenix receives FDA Refusal to File for HyBryte NDA in CTCL","bullets":["FDA issued Refusal to File (RTF) letter for HyBryte NDA for early-stage cutaneous T-cell lymphoma.","NDA submitted Dec 14, 2022 deemed not sufficiently complete for substantive review.","Soligenix plans to request a Type A meeting to clarify issues and seek guidance for resubmission.","Cutaneous T-cell lymphoma is a rare cancer affecting over 25,000 patients in the U.S."],"urls":{"canonical":"https://secwatch.observer/filing/0001558370-23-001226","json":"https://secwatch.observer/filing/0001558370-23-001226.json","markdown":"https://secwatch.observer/filing/0001558370-23-001226.md","text":"https://secwatch.observer/filing/0001558370-23-001226.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/812796/000155837023001226/0001558370-23-001226-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/812796/000155837023001226/tmb-20230214x8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-19T14:56:44.301033+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"}