{"schema_version":"secwatch.filing_event.v1","accession":"0001070081-25-000014","form_type":"8-K","ticker":"PTCT","cik":"0001070081","company_name":"PTC THERAPEUTICS, INC.","filed_at":"2025-05-05T23:59:59+00:00","discovered_at":"2026-05-14T18:02:47.411291+00:00","generated_at":"2026-05-22T16:18:09.712469+00:00","sec_items":["7.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"PTC518 Phase 2 PIVOT-HD meets primary endpoint with dose-dependent HTT lowering at Week 12","bullets":["Primary endpoint met: dose-dependent blood HTT protein reduction (p<0.0001) at Week 12.","5mg dose lowered HTT 23% in Stage 2/3; 10mg lowered 39% (Stage 2) and 36% (Stage 3).","Favorable dose-dependent trends on cUHDRS, TFC, SDMT in Stage 2 patients at 12 and 24 months.","No treatment-related SAEs or NfL spikes; safety and tolerability profile favorable.","At Month 24, dose-dependent NfL lowering: -8.9% (5mg, p=0.12) and -14% (10mg, p=0.03) vs natural history."],"urls":{"canonical":"https://secwatch.observer/filing/0001070081-25-000014","json":"https://secwatch.observer/filing/0001070081-25-000014.json","markdown":"https://secwatch.observer/filing/0001070081-25-000014.md","text":"https://secwatch.observer/filing/0001070081-25-000014.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1070081/000107008125000014/0001070081-25-000014-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1070081/000107008125000014/tmb-20250505x8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-22T16:18:09.712469+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"}