{"schema_version":"secwatch.filing_event.v1","accession":"0001711279-25-000013","form_type":"8-K","ticker":"KRYS","cik":"0001711279","company_name":"Krystal Biotech, Inc.","filed_at":"2025-02-28T23:59:59+00:00","discovered_at":"2026-05-14T18:03:04.543440+00:00","generated_at":"2026-05-25T23:41:13.596058+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Krystal Biotech receives positive CHMP opinion for VYJUVEK in EU; EC decision expected Q2 2025","bullets":["CHMP recommends EC approval of VYJUVEK for DEB wounds, including from birth, with option for at-home administration.","Final EC decision anticipated in Q2 2025, applicable to EU member states plus Iceland, Norway, Liechtenstein.","Positive opinion based on Phase 1/2 GEM-1 and Phase 3 GEM-3 data showing durable wound closure.","Company expects first European launch in Germany around mid-2025, followed by France later in 2025.","VYJUVEK previously approved by FDA in May 2023 for DEB patients aged 6 months and older in the U.S."],"urls":{"canonical":"https://secwatch.observer/filing/0001711279-25-000013","json":"https://secwatch.observer/filing/0001711279-25-000013.json","markdown":"https://secwatch.observer/filing/0001711279-25-000013.md","text":"https://secwatch.observer/filing/0001711279-25-000013.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1711279/000171127925000013/0001711279-25-000013-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1711279/000171127925000013/krys-20250228.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-25T23:41:13.596058+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"}