---
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"
generated_at: "2026-06-05T15:38:49.082509+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# MoonLake gets FDA & EMA support for Phase 3 sonelokimab in hidradenitis suppurativa

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 9.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001213900-24-016737
- JSON: https://secwatch.observer/filing/0001213900-24-016737.json
- Plain text: https://secwatch.observer/filing/0001213900-24-016737.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.