{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-25-029124","form_type":"8-K","ticker":"PTCT","cik":"0001070081","company_name":"PTC THERAPEUTICS, INC.","filed_at":"2025-03-28T23:59:59+00:00","discovered_at":"2026-05-14T18:03:02.863056+00:00","generated_at":"2026-05-24T02:53:13.398448+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"European Commission refuses renewal of Translarna (ataluren) marketing authorization in EU","bullets":["EC adopted CHMP negative opinion; renewal of conditional MA for nonsense mutation DMD denied.","Drug effectively removed from European Economic Area; authorization ends.","EC indicated EU member states may allow continued use under Articles 117(3) and 5(1) of Directive 2001/83.","PTC CEO expresses disappointment; plans to work country-by-country to maintain commercial access.","Decision based on CHMP conclusion that efficacy was not established and benefit-risk not confirmed."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-25-029124","json":"https://secwatch.observer/filing/0001104659-25-029124.json","markdown":"https://secwatch.observer/filing/0001104659-25-029124.md","text":"https://secwatch.observer/filing/0001104659-25-029124.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1070081/000110465925029124/0001104659-25-029124-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1070081/000110465925029124/tm2510789d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-24T02:53:13.398448+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"}