{"schema_version":"secwatch.filing_event.v1","accession":"0001558370-23-015770","form_type":"8-K","ticker":"PTCT","cik":"0001070081","company_name":"PTC THERAPEUTICS, INC.","filed_at":"2023-09-15T23:59:59+00:00","discovered_at":"2026-05-14T18:03:33.071512+00:00","generated_at":"2026-06-10T15:55:46.502649+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"CHMP issues negative opinion on Translarna full authorization; PTC to seek re-examination","bullets":["CHMP gave negative opinion on converting Translarna's conditional MA to full MA for nmDMD.","Negative opinion also applies to renewal of existing conditional authorization.","PTC will submit re-examination request; expected CHMP opinion in Jan 2024, EC ratification within 67 days.","Translarna stays on market for nmDMD patients during re-examination process.","PTC cites favorable safety profile & efficacy data from 3 placebo-controlled trials and STRIDE registry."],"urls":{"canonical":"https://secwatch.observer/filing/0001558370-23-015770","json":"https://secwatch.observer/filing/0001558370-23-015770.json","markdown":"https://secwatch.observer/filing/0001558370-23-015770.md","text":"https://secwatch.observer/filing/0001558370-23-015770.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1070081/000155837023015770/0001558370-23-015770-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1070081/000155837023015770/tmb-20230915x8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-10T15:55:46.502649+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"}