{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-25-088704","form_type":"8-K","ticker":"LRMR","cik":"0001374690","company_name":"Larimar Therapeutics, Inc.","filed_at":"2025-06-23T23:59:59+00:00","discovered_at":"2026-05-14T18:02:48.096978+00:00","generated_at":"2026-05-18T23:26:52.877488+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 gets FDA safety database guidance; nomlabofusp BLA submission planned for Q2 2026","bullets":["FDA recommends safety database of ≥30 participants with 6-month continuous exposure (≥10 with 1-year), majority on 50 mg dose.","BLA submission for accelerated approval now targeted for Q2 2026 to include recommended safety data.","OLE data expected September 2025 from 30-40 participants, including those on the 50 mg dose.","Adolescent PK run-in data also expected September 2025 from 14 participants (some placebo).","FDA open to skin frataxin as reasonably likely surrogate endpoint; global Phase 3 study activities ongoing."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-25-088704","json":"https://secwatch.observer/filing/0000950170-25-088704.json","markdown":"https://secwatch.observer/filing/0000950170-25-088704.md","text":"https://secwatch.observer/filing/0000950170-25-088704.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1374690/000095017025088704/0000950170-25-088704-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1374690/000095017025088704/lrmr-20250623.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-18T23:26:52.877488+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"}