{"schema_version":"secwatch.filing_event.v1","accession":"0001558370-24-008446","form_type":"8-K","ticker":"PTCT","cik":"0001070081","company_name":"PTC THERAPEUTICS, INC.","filed_at":"2024-05-20T23:59:59+00:00","discovered_at":"2026-05-14T18:03:17.170373+00:00","generated_at":"2026-06-01T12:13:47.405910+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"EC rejects CHMP negative opinion on Translarna; returns for re-evaluation; 2024 guidance paused","bullets":["EC decided not to adopt CHMP's negative opinion for Translarna annual renewal; returns to CHMP for re-evaluation.","Translarna remains authorized and available in Europe; EC asks CHMP to consider real-world evidence.","PTC pauses 2024 total revenue guidance due to uncertainty from continued Translarna authorization upside."],"urls":{"canonical":"https://secwatch.observer/filing/0001558370-24-008446","json":"https://secwatch.observer/filing/0001558370-24-008446.json","markdown":"https://secwatch.observer/filing/0001558370-24-008446.md","text":"https://secwatch.observer/filing/0001558370-24-008446.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1070081/000155837024008446/0001558370-24-008446-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1070081/000155837024008446/tmb-20240520x8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-01T12:13:47.405910+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"}