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MoonLake Announces Week 52 Results of Sonelokimab from its Phase 3 VELA Program in Hidradenitis Suppurativa and Confirms Investor Day on June 22, 2026

$MLTXPress releaseJun 21, 2026, 5:00 PM ETRead the release

MoonLake Immunotherapeutics reported positive Week 52 data from its Phase 3 VELA-1 and VELA-2 trials for sonelokimab in hidradenitis suppurativa (HS). 67.2% of patients achieved HiSCR75 and 33.1% achieved HiSCR100, with no new safety signals detected. The data supports a best-in-class profile, with superior efficacy compared to competitor agents and significant improvements in patient-reported outcomes like quality of life and pain. Interim data from the adolescent VELA-TEEN trial also showed strong response rates (~68% HiSCR75 at Week 24).

Key figures

Drug Name
sonelokimab
Phase Of Trial
Phase 3
Hiscr75 week52
67.2%
Hiscr100 week52
33.1%
Ihs4 100 week52
26.0%
Hisqol improvement
-15.0 points
Pain reduction pct
46.5%
Bla submission date
End of September 2026
Pduefa date expectation
End of November 2026
Vela teen hisr75 week24
~68%
Vela teen hisr100 week24
~45%

AI analysis

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