{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-065186","form_type":"8-K","ticker":"LRMR","cik":"0001374690","company_name":"Larimar Therapeutics, Inc.","filed_at":"2026-02-24T23:59:59+00:00","discovered_at":"2026-05-14T18:02:34.938873+00:00","generated_at":"2026-05-16T00:45:28.501613+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Larimar Therapeutics receives FDA Breakthrough Therapy Designation for nomlabofusp in Friedreich's ataxia","bullets":["FDA granted Breakthrough Therapy Designation for nomlabofusp for adults and children with Friedreich's ataxia.","FDA aligned on using skin FXN as a surrogate endpoint to support BLA seeking accelerated approval.","Planned BLA submission remains on track for June 2026; topline open-label data expected Q2 2026.","Global confirmatory Phase 3 study to initiate Q2 2026; first patient dosing targeted mid-2026.","U.S. launch targeted for first-half 2027, if approved; estimated 5,000 U.S. patients with FA."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-065186","json":"https://secwatch.observer/filing/0001193125-26-065186.json","markdown":"https://secwatch.observer/filing/0001193125-26-065186.md","text":"https://secwatch.observer/filing/0001193125-26-065186.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1374690/000119312526065186/0001193125-26-065186-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1374690/000119312526065186/lrmr-20260224.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T00:45:28.501613+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"}