{"schema_version":"secwatch.filing_event.v1","accession":"0001213900-25-092614","form_type":"8-K","ticker":"MLTX","cik":"0001821586","company_name":"MoonLake Immunotherapeutics","filed_at":"2025-09-29T23:59:59+00:00","discovered_at":"2026-05-14T18:02:45.138548+00:00","generated_at":"2026-05-17T05:26:09.743676+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"MoonLake VELA Ph3: VELA-1 meets primary HiSCR75 (p<0.001); VELA-2 misses but shows significance on treatment policy","bullets":["VELA-1 achieved HiSCR75 at week 16 with 34.8% vs 17.5% placebo, delta 17.3% (p<0.001).","VELA-2 primary composite analysis p=0.053; pre-specified treatment policy gave 35.9% vs 25.6% (p=0.033).","Combined: HiSCR75 35.4% vs 21.6% (p<0.001); all secondary endpoints significant (pain, DLQI, HiSQOL).","Safety favorable: no suicidal ideation, MACE; oral candidiasis 7.3% on sonelokimab vs 0.4% placebo.","Next milestones: Q4 2025 LEDA (PPP), Q1 2026 S-OLARIS (axSpA), Q2 2026 VELA 52-week data."],"urls":{"canonical":"https://secwatch.observer/filing/0001213900-25-092614","json":"https://secwatch.observer/filing/0001213900-25-092614.json","markdown":"https://secwatch.observer/filing/0001213900-25-092614.md","text":"https://secwatch.observer/filing/0001213900-25-092614.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1821586/000121390025092614/0001213900-25-092614-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1821586/000121390025092614/ea0259129-8k_moonlake.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T05:26:09.743676+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"}