{"schema_version":"secwatch.filing_event.v1","accession":"0001070081-24-000010","form_type":"8-K","ticker":"PTCT","cik":"0001070081","company_name":"PTC THERAPEUTICS, INC.","filed_at":"2024-06-28T23:59:59+00:00","discovered_at":"2026-05-14T18:03:17.170940+00:00","generated_at":"2026-06-01T00:24:41.954332+00:00","sec_items":["7.01","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 renewal; PTC plans re-examination","bullets":["CHMP issued negative opinion on renewal of conditional marketing authorization for Translarna (ataluren) for nmDMD.","Negative opinion follows EC request for re-review; PTC will request re-examination per EMA guidelines.","Marketing authorization remains in effect; Translarna expected on market through end of 2024 even if opinion upheld.","CEO Klein: 'STRIDE real-world evidence should not be ignored'; expert panel agreed evidence shows significant efficacy."],"urls":{"canonical":"https://secwatch.observer/filing/0001070081-24-000010","json":"https://secwatch.observer/filing/0001070081-24-000010.json","markdown":"https://secwatch.observer/filing/0001070081-24-000010.md","text":"https://secwatch.observer/filing/0001070081-24-000010.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1070081/000107008124000010/0001070081-24-000010-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1070081/000107008124000010/tmb-20240628x8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-01T00:24:41.954332+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"}