{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-23-146067","form_type":"8-K","ticker":"CABA","cik":"0001759138","company_name":"Cabaletta Bio, Inc.","filed_at":"2023-05-16T23:59:59+00:00","discovered_at":"2026-05-14T18:03:40.416883+00:00","generated_at":"2026-06-14T23:53:53.318729+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"FDA clears CABA-201 IND for Phase 1/2 myositis study; DesCAARTes updates provided","bullets":["FDA cleared second IND for CABA-201 (CD19-CAR T) for Phase 1/2 trial in active myositis (DM, ASyS, IMNM) at 1x10^6 cells/kg dose.","Company plans to enroll 18 patients in three parallel cohorts (6 each) for dermatomyositis, anti-synthetase syndrome, and immune-mediated necrotizing myopathy.","DesCAARTes trial: modest persistence increase in first two patients in IVIg+Cy combination cohort; new fludarabine+IVIg+Cy cohort to be initiated.","MusCAARTes study timelines being evaluated based on emerging DesCAARTes data.","Myositis subtypes targeted affect ~66,000 patients in the US; current treatments often refractory."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-23-146067","json":"https://secwatch.observer/filing/0001193125-23-146067.json","markdown":"https://secwatch.observer/filing/0001193125-23-146067.md","text":"https://secwatch.observer/filing/0001193125-23-146067.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1759138/000119312523146067/0001193125-23-146067-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1759138/000119312523146067/d492544d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-14T23:53:53.318729+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"}