---
schema_version: "secwatch.filing_event.v1"
accession: "0001213900-24-051263"
form_type: "8-K"
ticker: "MLTX"
cik: "0001821586"
company_name: "MoonLake Immunotherapeutics"
filed_at: "2024-06-10T23:59:59+00:00"
generated_at: "2026-06-01T05:21:53.795042+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# FDA and EMA back MoonLake's Phase 3 program for sonelokimab in psoriatic arthritis

## Summary
- FDA and EMA unanimously supported MoonLake's proposed Phase 3 IZAR program for sonelokimab in PsA.
- Phase 3 design: ~1,500 patients across two trials (IZAR-1 bio-naïve, IZAR-2 TNF-IR with risankizumab reference).
- Doses 60mg and 120mg; primary endpoint ACR50 at week 16; first patient Q4 2024, topline readout end-2026.
- Follows positive FDA/EMA feedback for HS Phase 3 VELA program; Phase 3 HS recruitment already started.
- Phase 2 ARGO data plus IZAR intended to support BLA and EU MAA for sonelokimab in PsA.

## SEC filing metadata
- accession: 0001213900-24-051263
- form_type: 8-K
- ticker: MLTX
- cik: 0001821586
- company_name: MoonLake Immunotherapeutics
- filed_at: 2024-06-10T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1821586/000121390024051263/0001213900-24-051263-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1821586/000121390024051263/ea0207582-8k_moonlake.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001213900-24-051263
- JSON: https://secwatch.observer/filing/0001213900-24-051263.json
- Plain text: https://secwatch.observer/filing/0001213900-24-051263.txt

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