{"schema_version":"secwatch.filing_event.v1","accession":"0001213900-26-070362","form_type":"8-K","ticker":"MLTX","cik":"0001821586","company_name":"MoonLake Immunotherapeutics","filed_at":"2026-06-22T11:00:32+00:00","discovered_at":"2026-06-22T11:05:01.252129+00:00","generated_at":"2026-06-22T11:05:46.858407+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"MoonLake Phase 3 VELA Week 52: 67% HiSCR75, 33% HiSCR100; BLA submission end-Sept 2026","bullets":["Across VELA-1/2, 67.2% of SLK-treated patients achieved HiSCR75, 33.1% HiSCR100 at Week 52 (n=396).","26.0% achieved IHS4-100 remission; HiSQOL improved by mean -15.0 points from baseline.","46.5% of patients had marked pain reduction (≥3-point drop in worst skin pain NRS).","VELA-TEEN interim: ~68% HiSCR75, ~45% HiSCR100 at Week 24 in adolescents (n=22).","BLA submission for SLK in HS expected end of September 2026; PDUFA date by late Nov 2026."],"urls":{"canonical":"https://secwatch.observer/filing/0001213900-26-070362","json":"https://secwatch.observer/filing/0001213900-26-070362.json","markdown":"https://secwatch.observer/filing/0001213900-26-070362.md","text":"https://secwatch.observer/filing/0001213900-26-070362.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1821586/000121390026070362/0001213900-26-070362-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1821586/000121390026070362/ea0295399-8k_moonlake.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-22T11:05:46.858407+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"}