---
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"
generated_at: "2026-06-22T11:05:46.858407+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# MoonLake Phase 3 VELA Week 52: 67% HiSCR75, 33% HiSCR100; BLA submission end-Sept 2026

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: other_material
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001213900-26-070362
- JSON: https://secwatch.observer/filing/0001213900-26-070362.json
- Plain text: https://secwatch.observer/filing/0001213900-26-070362.txt

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