{"schema_version":"secwatch.filing_event.v1","accession":"0001213900-24-060281","form_type":"8-K","ticker":"LGVN","cik":"0001721484","company_name":"Longeveron Inc.","filed_at":"2024-07-10T23:59:59+00:00","discovered_at":"2026-05-14T18:03:14.265287+00:00","generated_at":"2026-05-31T22:10:09.595728+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":"Longeveron receives FDA RMAT designation for Lomecel-B in mild Alzheimer's disease","bullets":["FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation for Lomecel-B for mild Alzheimer's disease.","Lomecel-B is the first cellular therapeutic candidate to receive RMAT designation for Alzheimer's disease.","CLEAR MIND Phase 2a trial met primary safety and secondary efficacy endpoints; full results at AAIC on July 28, 2024.","This is the fourth special FDA designation for Lomecel-B; HLHS program holds Orphan Drug, Fast Track, and Rare Pediatric Disease designations.","RMAT designation enables intensive FDA guidance and potential expedited review and accelerated approval pathways."],"urls":{"canonical":"https://secwatch.observer/filing/0001213900-24-060281","json":"https://secwatch.observer/filing/0001213900-24-060281.json","markdown":"https://secwatch.observer/filing/0001213900-24-060281.md","text":"https://secwatch.observer/filing/0001213900-24-060281.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1721484/000121390024060281/0001213900-24-060281-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1721484/000121390024060281/ea0209181-8k_longeveron.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-31T22:10:09.595728+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"}