{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-23-006834","form_type":"8-K","ticker":"FULC","cik":"0001680581","company_name":"Fulcrum Therapeutics, Inc.","filed_at":"2023-03-09T23:59:59+00:00","discovered_at":"2026-05-14T18:03:46.119379+00:00","generated_at":"2026-06-18T07:10:18.634053+00:00","sec_items":["2.02","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"FDA places FTX-6058 on clinical hold; Fulcrum reports Q4/FY2022 results","bullets":["FDA placed full clinical hold on FTX-6058 IND for sickle cell disease; enrollment paused and dosing suspended.","Phase 1b 12 mg cohort showed up to 10% absolute HbF increase; company working to address FDA concerns.","Losmapimod Phase 3 REACH trial enrollment on track to complete in second half of 2023.","Completed $117.3M public offering in January 2023; cash runway extends into mid-2025.","CMO Santiago Arroyo resigned; Iain Fraser appointed Interim CMO, effective March 9, 2023."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-23-006834","json":"https://secwatch.observer/filing/0000950170-23-006834.json","markdown":"https://secwatch.observer/filing/0000950170-23-006834.md","text":"https://secwatch.observer/filing/0000950170-23-006834.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1680581/000095017023006834/0000950170-23-006834-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1680581/000095017023006834/fulc-20230309.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-18T07:10:18.634053+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":[{"claim_id":"dc6414935c3b96e2f436da8dba4c7602828cccc6","claim":"Fulcrum Therapeutics, Inc. reported financial results for the quarter and year ended December 31, 2022.","evidence_excerpt":"On March 9, 2023, Fulcrum Therapeutics, Inc., or Fulcrum, announced its financial results for the quarter and year ended December 31, 2022.","evidence_source":"SEC 8-K Item 2.02","evidence_url":"https://www.sec.gov/Archives/edgar/data/1680581/000095017023006834/0000950170-23-006834-index.htm","confidence":0.9,"family_label":"Earnings Releases","details":[{"label":"Period","value":"the quarter and year ended December 31, 2022"},{"label":"Result","value":"reported results"}],"fact_type":"earnings_release"}],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}