{"schema_version":"secwatch.filing_event.v1","accession":"0001711279-26-000005","form_type":"8-K","ticker":"KRYS","cik":"0001711279","company_name":"Krystal Biotech, Inc.","filed_at":"2026-01-08T23:59:59+00:00","discovered_at":"2026-05-14T18:02:35.970923+00:00","generated_at":"2026-05-16T11:13:41.911786+00:00","sec_items":["7.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"Krystal Biotech KB407 Phase 1 positive: CFTR delivery confirmed in all 6 biopsied patients","bullets":["Confirmed wild-type CFTR delivery and expression in conducting airway cells of patients with class I mutations (modulator ineligible).","Transduction rates ranged 29.4% to 42.1% across six patients; all biopsies positive for CFTR or viral marker.","KB407 well tolerated; one SAE (asthma exacerbation) deemed procedure-related, resolved in 5 days.","Registrational CORAL-3 study design submitted to FDA; enrollment expected 1H 2026 after alignment.","Four of seven highest-dose patients were modulator ineligible; data supports mutation-agnostic potential."],"urls":{"canonical":"https://secwatch.observer/filing/0001711279-26-000005","json":"https://secwatch.observer/filing/0001711279-26-000005.json","markdown":"https://secwatch.observer/filing/0001711279-26-000005.md","text":"https://secwatch.observer/filing/0001711279-26-000005.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1711279/000171127926000005/0001711279-26-000005-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1711279/000171127926000005/krys-20260108.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T11:13:41.911786+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"}