{"schema_version":"secwatch.filing_event.v1","accession":"0001711279-22-000052","form_type":"8-K","ticker":"KRYS","cik":"0001711279","company_name":"Krystal Biotech, Inc.","filed_at":"2022-08-18T23:59:59+00:00","discovered_at":"2026-05-14T18:03:56.746357+00:00","generated_at":"2026-06-23T22:51:17.374402+00:00","sec_items":["7.01","8.01","99.1","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"FDA accepts Krystal Biotech's BLA for B-VEC with Priority Review; PDUFA Feb 2023","bullets":["FDA accepted BLA for B-VEC (gene therapy) to treat dystrophic epidermolysis bullosa (DEB).","Granted Priority Review; PDUFA target action date set for February 17, 2023.","FDA stated it does not currently plan to hold an advisory committee meeting on this BLA.","B-VEC previously received Fast Track and Regenerative Medicine Advanced Therapy (RMAT) designations.","Company plans to submit marketing authorization application to EMA in H2 2022."],"urls":{"canonical":"https://secwatch.observer/filing/0001711279-22-000052","json":"https://secwatch.observer/filing/0001711279-22-000052.json","markdown":"https://secwatch.observer/filing/0001711279-22-000052.md","text":"https://secwatch.observer/filing/0001711279-22-000052.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1711279/000171127922000052/0001711279-22-000052-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1711279/000171127922000052/krys-20220818.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-23T22:51:17.374402+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"}