{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-286780","form_type":"8-K","ticker":"LRMR","cik":"0001374690","company_name":"Larimar Therapeutics, Inc.","filed_at":"2026-06-29T10:33:36+00:00","discovered_at":"2026-06-29T10:35:00.259312+00:00","generated_at":"2026-06-29T10:35:19.501667+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Larimar submits BLA module for nomlabofusp accelerated approval; positive open-label data in Friedreich's ataxia","bullets":["Submitted first module of rolling BLA to FDA for accelerated approval of nomlabofusp; FDA confirmed existing data appears sufficient.","Open-label study: 100% (9/9) of participants achieved skin FXN levels >50% of healthy volunteer mean at 1 year.","Clinical outcomes improved vs natural history: mean 1.0-point mFARS improvement vs 1.6-point worsening at 1 year.","Safety: anaphylaxis in 10/43 patients; 9 had prior nomlabofusp exposure, 1 no prior; all recovered.","First patient in confirmatory Phase 3 expected Q3 2026; targeting mid-2027 launch if approved."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-286780","json":"https://secwatch.observer/filing/0001193125-26-286780.json","markdown":"https://secwatch.observer/filing/0001193125-26-286780.md","text":"https://secwatch.observer/filing/0001193125-26-286780.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1374690/000119312526286780/0001193125-26-286780-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1374690/000119312526286780/lrmr-20260629.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-29T10:35:19.501667+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"}