{"schema_version":"secwatch.filing_event.v1","accession":"0001711279-26-000064","form_type":"8-K","ticker":"KRYS","cik":"0001711279","company_name":"Krystal Biotech, Inc.","filed_at":"2026-10-15T11:02:30+00:00","discovered_at":"2026-10-15T11:05:00.392653+00:00","generated_at":"2026-10-15T11:05:09.175072+00:00","sec_items":["7.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.55,"calibrated_materiality_score":0.55,"confidence":"high","headline":"Krystal Biotech KB113 pilot: 83% of BCC lesions regressed in 3 Gorlin syndrome patients","bullets":["Over 80% of assessed landmark lesions regressed: 69/83 (83.1%) any regression; 42/83 (50.6%) >50% reduction; 8/83 (9.6%) at least 90% reduction.","Substantial regression in non-injected lesions (40/47, 85.1%) suggests an abscopal effect; all three biopsied injected lesions showed histologically confirmed complete response.","Three adults received six intralesional doses of up to 2 mL of 10^8 PFU/mL KB113 over 14 weeks; all 22 adverse events were mild/moderate and resolved, with no serious AEs.","KB113 is the low dose of intratumoral KB707 from OPAL-1 (NCT05970497); Krystal has begun FDA discussions on advanced development for Gorlin syndrome.","Data presented by investigator Dr. Shireen Guide at the 14th PeDRA Annual Conference, Oct 15-17, 2026; US Gorlin syndrome prevalence may exceed 10,000 patients."],"urls":{"canonical":"https://secwatch.observer/filing/0001711279-26-000064","json":"https://secwatch.observer/filing/0001711279-26-000064.json","markdown":"https://secwatch.observer/filing/0001711279-26-000064.md","text":"https://secwatch.observer/filing/0001711279-26-000064.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1711279/000171127926000064/0001711279-26-000064-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1711279/000171127926000064/krys-20261015.htm"},"model":{"generated_by":"deepseek-v4.1-flash:cloud@v2","generated_at":"2026-10-15T11:05:09.175072+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"}