{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-23-034217","form_type":"8-K","ticker":"LRMR","cik":"0001374690","company_name":"Larimar Therapeutics, Inc.","filed_at":"2023-07-25T23:59:59+00:00","discovered_at":"2026-05-14T18:03:33.735067+00:00","generated_at":"2026-06-13T02:59:10.925980+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"FDA clears Larimar's Phase 2 CTI-1601 trial to proceed to 50 mg cohort and OLE trial","bullets":["FDA cleared Phase 2 dose exploration trial to proceed to 50 mg cohort; dosed daily for 14 days then every other day to day 28.","FDA also cleared initiation of open label extension (OLE) trial with 25 mg daily CTI-1601; enrollment expected Q1 2024, interim data Q4 2024.","Top-line safety, PK, and frataxin data from the 50 mg cohort expected in first half of 2024.","Clearance follows FDA review of unblinded data from completed 25 mg cohort (n=13) showing frataxin increases vs placebo.","Further dose escalation and additional U.S. trials remain under partial clinical hold pending FDA review of 50 mg cohort results."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-23-034217","json":"https://secwatch.observer/filing/0000950170-23-034217.json","markdown":"https://secwatch.observer/filing/0000950170-23-034217.md","text":"https://secwatch.observer/filing/0000950170-23-034217.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1374690/000095017023034217/0000950170-23-034217-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1374690/000095017023034217/lrmr-20230725.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-13T02:59:10.925980+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"}