{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-453586","form_type":"8-K","ticker":"LRMR","cik":"0001374690","company_name":"Larimar Therapeutics, Inc.","filed_at":"2026-11-09T21:08:26+00:00","discovered_at":"2026-11-09T21:10:00.261494+00:00","generated_at":"2026-11-09T21:10:21.483210+00:00","sec_items":["2.02","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Larimar completes rolling BLA for nomlabofusp in Friedreich's ataxia; cash $128.7M","bullets":["Rolling Biologics License Application submitted to FDA seeking accelerated approval of nomlabofusp, a frataxin replacement therapy, for Friedreich's ataxia.","BLA relies on skin frataxin as a potential novel surrogate endpoint; FDA previously confirmed the data package appears capable of supporting submission and review.","Preliminary cash, cash equivalents and marketable securities of ~$128.7M as of Sept 30, 2026; quarter-end close still ongoing and figure unaudited.","Milestones: BLA acceptance early 2027, open-label safety update Q1 2027, U.S. approval mid-2027, launch targeted Q3 2027, if approved.","FORWARD-FA confirmatory Phase 3 enrolling: double-blind, placebo-controlled, 18 months, ages 2-40, ~two-thirds under 21; Breakthrough and Orphan designations held."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-453586","json":"https://secwatch.observer/filing/0001193125-26-453586.json","markdown":"https://secwatch.observer/filing/0001193125-26-453586.md","text":"https://secwatch.observer/filing/0001193125-26-453586.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1374690/000119312526453586/0001193125-26-453586-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1374690/000119312526453586/lrmr-20261109.htm"},"model":{"generated_by":"deepseek-v4.1-flash:cloud@v2","generated_at":"2026-11-09T21:10:21.483210+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"}