{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-23-270840","form_type":"8-K","ticker":"CABA","cik":"0001759138","company_name":"Cabaletta Bio, Inc.","filed_at":"2023-11-06T23:59:59+00:00","discovered_at":"2026-05-14T18:03:30.334959+00:00","generated_at":"2026-06-08T21:17:14.559854+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"Cabaletta Bio receives FDA clearance for fourth CABA-201 IND, now in generalized myasthenia gravis","bullets":["FDA cleared IND for CABA-201 in generalized MG; fourth IND across autoimmune diseases.","Phase 1/2 trial to enroll 12 patients in two parallel cohorts: AChR+ (n=6) and AChR- (n=6).","Starting dose remains 1 x 10^6 cells/kg, consistent with lupus, myositis, and systemic sclerosis trials.","gMG affects ~85% of an estimated 50,000-80,000 MG patients in the U.S.","Company expects initial clinical data from lupus/myositis trials in H1 2024."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-23-270840","json":"https://secwatch.observer/filing/0001193125-23-270840.json","markdown":"https://secwatch.observer/filing/0001193125-23-270840.md","text":"https://secwatch.observer/filing/0001193125-23-270840.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1759138/000119312523270840/0001193125-23-270840-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1759138/000119312523270840/d854062d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-08T21:17:14.559854+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"}