{"schema_version":"secwatch.filing_event.v1","accession":"0001711279-23-000061","form_type":"8-K","ticker":"KRYS","cik":"0001711279","company_name":"Krystal Biotech, Inc.","filed_at":"2023-07-26T23:59:59+00:00","discovered_at":"2026-05-14T18:03:34.946147+00:00","generated_at":"2026-06-13T02:23:33.316963+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 expands to oncology; FDA accepts IND for KB707 for solid tumors","bullets":["FDA accepted IND for KB707, a modified HSV-1 vector delivering IL-12 and IL-2 for solid tumors.","Two formulations: intratumoral injection for accessible tumors and inhaled (nebulized) for lung delivery.","Phase 1 Opal 1 study to start 2H 2023; amendment for inhaled formulation expected in 2H 2023.","Preclinical data showed antitumor responses in checkpoint-inhibitor-refractory mouse models.","Investor conference call on July 27, 2023 at 8:00 AM ET to discuss KB707 program."],"urls":{"canonical":"https://secwatch.observer/filing/0001711279-23-000061","json":"https://secwatch.observer/filing/0001711279-23-000061.json","markdown":"https://secwatch.observer/filing/0001711279-23-000061.md","text":"https://secwatch.observer/filing/0001711279-23-000061.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1711279/000171127923000061/0001711279-23-000061-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1711279/000171127923000061/krys-20230726.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-13T02:23:33.316963+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"}