---
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"
generated_at: "2026-05-17T05:26:09.743676+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# MoonLake VELA Ph3: VELA-1 meets primary HiSCR75 (p<0.001); VELA-2 misses but shows significance on treatment policy

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: other_material
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 8.01, 9.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001213900-25-092614
- JSON: https://secwatch.observer/filing/0001213900-25-092614.json
- Plain text: https://secwatch.observer/filing/0001213900-25-092614.txt

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