{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-25-071966","form_type":"8-K","ticker":"CABA","cik":"0001759138","company_name":"Cabaletta Bio, Inc.","filed_at":"2025-05-15T23:59:59+00:00","discovered_at":"2026-05-14T18:02:49.611733+00:00","generated_at":"2026-05-21T05:23:06.311137+00:00","sec_items":["2.02","7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Cabaletta Bio to file BLA for rese-cel in myositis in 2027 after FDA alignment; cash $131.8M","bullets":["FDA aligned on two registrational cohorts for rese-cel in myositis (~15 patients each, 26-week primary endpoint); BLA submission expected in 2027.","RMAT designation granted for rese-cel in myositis, enabling Fast Track/Breakthrough benefits and expedited BLA review.","Cash and equivalents $131.8M at March 31, 2025, down from $164M at Dec 31, 2024; funding into first half 2026.","FDA registrational discussions for SLE/LN anticipated in 3Q25; for systemic sclerosis in 4Q25.","Three oral presentations of rese-cel data in myositis, SLE/LN, and systemic sclerosis at EULAR 2025 in June."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-25-071966","json":"https://secwatch.observer/filing/0000950170-25-071966.json","markdown":"https://secwatch.observer/filing/0000950170-25-071966.md","text":"https://secwatch.observer/filing/0000950170-25-071966.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1759138/000095017025071966/0000950170-25-071966-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1759138/000095017025071966/caba-20250515.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-21T05:23:06.311137+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"}