{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-26-014414","form_type":"8-K","ticker":"PTCT","cik":"0001070081","company_name":"PTC THERAPEUTICS, INC.","filed_at":"2026-02-12T23:59:59+00:00","discovered_at":"2026-05-14T18:02:34.496937+00:00","generated_at":"2026-05-16T02:54:36.040057+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":"PTC Therapeutics withdraws Translarna NDA resubmission after FDA cites insufficient efficacy data","bullets":["Withdrew NDA resubmission for Translarna (ataluren) for nonsense mutation Duchenne muscular dystrophy.","FDA feedback indicated data unlikely to meet substantial evidence of effectiveness threshold.","CEO Matthew Klein expressed disappointment after more than two decades of development efforts.","No path to FDA approval for Translarna in the U.S. at this time.","PTC Therapeutics (PTCT) shares potential negative impact from this regulatory setback."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-26-014414","json":"https://secwatch.observer/filing/0001104659-26-014414.json","markdown":"https://secwatch.observer/filing/0001104659-26-014414.md","text":"https://secwatch.observer/filing/0001104659-26-014414.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1070081/000110465926014414/0001104659-26-014414-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1070081/000110465926014414/tmb-20260212x8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T02:54:36.040057+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"}