secwatch.observer — SEC 8-K summary
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Issuer:     MoonLake Immunotherapeutics (MLTX)
CIK:        0001821586
Form:       8-K
Filed at:   2023-11-06T23:59:59+00:00
Accession:  0001628280-23-036888
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

MoonLake Phase 2 ARGO trial meets primary endpoint; sonelokimab ACR50 46-47% vs placebo
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- ACR50 achieved by 46% (60mg) and 47% (120mg) with induction at week 12 (p<0.01 vs placebo; ITT-NRI).
- Key secondary endpoint PASI90 reached by 77% (60mg) and PASI100 by 58% (60mg) at week 12.
- Discontinuation rate <4%; no new safety signals; oral candidiasis <2%, no IBD/MACE/SI/B.
- Sonelokimab numerically outperformed adalimumab on primary and key secondary endpoints.
- Company plans Phase 3 in PsA; end-of-Phase 2 regulatory meeting timing to be announced.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1821586/000162828023036888/0001628280-23-036888-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1821586/000162828023036888/mltx-20231105.htm
  HTML page:      https://secwatch.observer/filing/0001628280-23-036888

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer