{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-26-045219","form_type":"8-K","ticker":"PASG","cik":"0001787297","company_name":"Passage BIO, Inc.","filed_at":"2026-04-20T23:59:59+00:00","discovered_at":"2026-05-14T18:02:32.907050+00:00","generated_at":"2026-05-15T05:21:17.834322+00:00","sec_items":["7.01","9.01"],"event_type":"other_material","sentiment":"negative","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"PBFT02 cuts brain atrophy 64% vs natural history; FDA demands randomized trial; strategic review begun","bullets":["PBFT02 patients with global CDR 1 at baseline showed 64% less whole brain atrophy (3.1% vs 8.7%) at 12 months vs ALLFTD natural history.","FDA Type C meeting indicated a randomized controlled registrational trial is required for PBFT02 in FTD-GRN.","Company initiated a review of strategic alternatives including merger, sale, or licensing; engaged Wedbush PacGrow as advisor.","No new treatment-related SAEs; prior asymptomatic SAEs (venous sinus thrombosis, hepatotoxicity) remain unchanged.","Plasma NfL stabilized at 12 months (average -1.0 pg/mL) vs +13.5 pg/mL in untreated natural history patients."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-26-045219","json":"https://secwatch.observer/filing/0001104659-26-045219.json","markdown":"https://secwatch.observer/filing/0001104659-26-045219.md","text":"https://secwatch.observer/filing/0001104659-26-045219.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1787297/000110465926045219/0001104659-26-045219-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1787297/000110465926045219/tm2612152d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-15T05:21:17.834322+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"}