{"schema_version":"secwatch.filing_event.v1","accession":"0001690585-26-000010","form_type":"8-K","ticker":"DNTH","cik":"0001690585","company_name":"Dianthus Therapeutics, Inc. /DE/","filed_at":"2026-03-26T23:59:59+00:00","discovered_at":"2026-05-14T18:02:35.901959+00:00","generated_at":"2026-05-15T08:51:01.060356+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":"FDA agrees to remove ANA screening, reclassify lupus risk for Dianthus' claseprubart trials","bullets":["FDA agreed to remove anti-nuclear antibodies (ANAs) as screening criteria for all ongoing and future claseprubart trials.","Routine ANA testing during claseprubart trials will be eliminated per FDA feedback.","Hypothetical risk reclassified from systemic lupus erythematosus (SLE) to drug-induced lupus (DIL), a reversible side effect.","No cases of SLE or DIL have been observed in any claseprubart program to date.","Company posted an updated corporate presentation on its website summarizing these changes."],"urls":{"canonical":"https://secwatch.observer/filing/0001690585-26-000010","json":"https://secwatch.observer/filing/0001690585-26-000010.json","markdown":"https://secwatch.observer/filing/0001690585-26-000010.md","text":"https://secwatch.observer/filing/0001690585-26-000010.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1690585/000169058526000010/0001690585-26-000010-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1690585/000169058526000010/dnth-20260326.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-15T08:51:01.060356+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"}