{"schema_version":"secwatch.filing_event.v1","accession":"0001815776-24-000053","form_type":"8-K","ticker":"LENZ","cik":"0001815776","company_name":"LENZ Therapeutics, Inc.","filed_at":"2024-08-12T23:59:59+00:00","discovered_at":"2026-05-14T18:03:14.630623+00:00","generated_at":"2026-05-31T10:07:15.509535+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":"LENZ submits NDA for LNZ100 (aceclidine) to FDA for presbyopia treatment","bullets":["NDA supported by Phase 3 CLARITY study: met all primary and secondary near vision endpoints.","LNZ100 is an aceclidine-based eye drop targeting presbyopia, affecting ~1.8B people globally.","No serious treatment-related adverse events observed over 30,000 study days.","FDA has 60-day filing review period to determine NDA completeness for acceptance."],"urls":{"canonical":"https://secwatch.observer/filing/0001815776-24-000053","json":"https://secwatch.observer/filing/0001815776-24-000053.json","markdown":"https://secwatch.observer/filing/0001815776-24-000053.md","text":"https://secwatch.observer/filing/0001815776-24-000053.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1815776/000181577624000053/0001815776-24-000053-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1815776/000181577624000053/lenz-20240812.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-31T10:07:15.509535+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"}