{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-22-094363","form_type":"8-K","ticker":"CRIS","cik":"0001108205","company_name":"CURIS INC","filed_at":"2022-04-04T23:59:59+00:00","discovered_at":"2026-05-14T18:03:59.775068+00:00","generated_at":"2026-06-26T09:41:50.718331+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"FDA partial clinical hold on Curis leukemia study after patient death; lymphoma study paused","bullets":["FDA partial clinical hold on TakeAim Leukemia Phase 1/2a (NCT04278768); no new patients enrolled.","Hold triggered by death of R/R AML patient; rhabdomyolysis identified as dose-limiting toxicity.","Current patients may continue on emavusertib at ≤300mg BID; FDA requests additional safety data.","Curis voluntarily pauses enrollment in TakeAim Lymphoma study (NCT03328078) pending hold resolution.","FDA also requests data on Recommended Phase 2 Dose determination for emavusertib."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-22-094363","json":"https://secwatch.observer/filing/0001193125-22-094363.json","markdown":"https://secwatch.observer/filing/0001193125-22-094363.md","text":"https://secwatch.observer/filing/0001193125-22-094363.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1108205/000119312522094363/0001193125-22-094363-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1108205/000119312522094363/d318642d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-26T09:41:50.718331+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"}