{"schema_version":"secwatch.filing_event.v1","accession":"0001558370-23-005925","form_type":"8-K","ticker":"SNGX","cik":"0000812796","company_name":"SOLIGENIX, INC.","filed_at":"2023-04-14T23:59:59+00:00","discovered_at":"2026-05-14T18:03:42.334353+00:00","generated_at":"2026-06-17T02:18:37.304680+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Soligenix says FDA requires second Phase 3 study for HyBryte NDA after Type A meeting","bullets":["FDA refused to file NDA for HyBryte (CTCL); requires positive results from a second clinical study.","Type A Meeting held April 14, 2023; FDA open to protocol discussions for the additional study.","Company disappointed but will collaborate with FDA; evaluating feasibility of conducting the trial.","Phase 3 FLASH study was the largest double-blind, placebo-controlled CTCL trial; met primary endpoint."],"urls":{"canonical":"https://secwatch.observer/filing/0001558370-23-005925","json":"https://secwatch.observer/filing/0001558370-23-005925.json","markdown":"https://secwatch.observer/filing/0001558370-23-005925.md","text":"https://secwatch.observer/filing/0001558370-23-005925.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/812796/000155837023005925/0001558370-23-005925-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/812796/000155837023005925/sngx-20230414x8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-17T02:18:37.304680+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"}