{"schema_version":"secwatch.filing_event.v1","accession":"0001213900-24-016737","form_type":"8-K","ticker":"MLTX","cik":"0001821586","company_name":"MoonLake Immunotherapeutics","filed_at":"2024-02-26T23:59:59+00:00","discovered_at":"2026-05-14T18:03:25.733331+00:00","generated_at":"2026-06-05T15:38:49.082509+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"MoonLake gets FDA & EMA support for Phase 3 sonelokimab in hidradenitis suppurativa","bullets":["FDA and EMA both support Phase 3 design for sonelokimab (SLK) in HS; trial named VELA.","Phase 3 will enroll 800 patients; single 120mg dose vs placebo over 16 weeks; primary endpoint HiSCR75.","First patient randomization expected Q2 2024; primary endpoint readout mid-2025.","Combined Phase 2 and Phase 3 data to support BLA and EU marketing application.","End-of-Phase 2 meeting for PsA with FDA expected Q2 2024; Phase 3 start Q4 2024."],"urls":{"canonical":"https://secwatch.observer/filing/0001213900-24-016737","json":"https://secwatch.observer/filing/0001213900-24-016737.json","markdown":"https://secwatch.observer/filing/0001213900-24-016737.md","text":"https://secwatch.observer/filing/0001213900-24-016737.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1821586/000121390024016737/0001213900-24-016737-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1821586/000121390024016737/ea0200697-8k_moonlake.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-05T15:38:49.082509+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"}