{"schema_version":"secwatch.filing_event.v1","accession":"0001070081-23-000043","form_type":"8-K","ticker":"PTCT","cik":"0001070081","company_name":"PTC THERAPEUTICS, INC.","filed_at":"2023-07-19T23:59:59+00:00","discovered_at":"2026-05-14T18:03:33.071096+00:00","generated_at":"2026-06-13T06:13:09.618762+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"PTC Therapeutics provides regulatory timeline updates for sepiapterin, Upstaza, Translarna","bullets":["Expects to submit NDA to FDA for sepiapterin (PKU) in Q4 2023.","Expects to submit BLA to FDA for Upstaza (AADC deficiency) in Q3 2023.","Expects CHMP opinion in Q3 2023 for Translarna (nmDMD) conversion to standard EU authorization.","Preparing Type C FDA meetings for Translarna NDA resubmission and vatiquinone NDA for Friedreich ataxia."],"urls":{"canonical":"https://secwatch.observer/filing/0001070081-23-000043","json":"https://secwatch.observer/filing/0001070081-23-000043.json","markdown":"https://secwatch.observer/filing/0001070081-23-000043.md","text":"https://secwatch.observer/filing/0001070081-23-000043.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1070081/000107008123000043/0001070081-23-000043-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1070081/000107008123000043/tmb-20230719x8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-13T06:13:09.618762+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"}