{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-24-072048","form_type":"8-K","ticker":"CABA","cik":"0001759138","company_name":"Cabaletta Bio, Inc.","filed_at":"2024-03-20T23:59:59+00:00","discovered_at":"2026-05-14T18:03:25.422140+00:00","generated_at":"2026-06-04T11:50:18.418808+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Cabaletta Bio receives FDA Orphan Drug Designation for CABA-201 in systemic sclerosis","bullets":["FDA grants Orphan Drug Designation to CABA-201 for systemic sclerosis, a rare autoimmune disease.","CABA-201 is a fully human CD19-CAR T cell therapy being studied in Phase 1/2 RESET-SSc trial.","ODD provides tax credits, waived user fees, and potential 7-year marketing exclusivity upon approval.","Systemic sclerosis affects <200,000 US patients; average survival ~12 years after diagnosis."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-24-072048","json":"https://secwatch.observer/filing/0001193125-24-072048.json","markdown":"https://secwatch.observer/filing/0001193125-24-072048.md","text":"https://secwatch.observer/filing/0001193125-24-072048.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1759138/000119312524072048/0001193125-24-072048-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1759138/000119312524072048/d812029d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-04T11:50:18.418808+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"}