{"schema_version":"secwatch.filing_event.v1","accession":"0001108205-23-000054","form_type":"8-K","ticker":"CRIS","cik":"0001108205","company_name":"CURIS INC","filed_at":"2023-07-06T23:59:59+00:00","discovered_at":"2026-05-14T18:03:33.156545+00:00","generated_at":"2026-06-13T11:35:22.896869+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"FDA lifts partial clinical hold on Curis leukemia study; RP2D set at 300 mg BID","bullets":["FDA removed partial clinical hold on TakeAim Leukemia Phase 1/2 study of emavusertib (CA-4948).","Recommended Phase 2 dose (RP2D) for monotherapy established at 300 mg BID in AML/MDS patients.","At 300 mg BID, 2 of 3 FLT3-mutant AML patients achieved CR; 2 of 3 spliceosome-mutant achieved CR/CRh.","Company plans to enroll targeted AML patients and initiate front-line combination study with azacitidine/venetoclax.","Expects updated monotherapy data, registrational study design, and initial combo data in 2024."],"urls":{"canonical":"https://secwatch.observer/filing/0001108205-23-000054","json":"https://secwatch.observer/filing/0001108205-23-000054.json","markdown":"https://secwatch.observer/filing/0001108205-23-000054.md","text":"https://secwatch.observer/filing/0001108205-23-000054.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1108205/000110820523000054/0001108205-23-000054-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1108205/000110820523000054/cris-20230706.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-13T11:35:22.896869+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"}