MoonLake Eyes Q2 52-Week HS Readout and September 2026 FDA Filing
MLTX•MoonLake Immunotherapeutics will report 52-week results from two late-stage hidradenitis suppurativa trials in Q2 after Week-16 data showed one met its primary endpoint while the other narrowly missed due to high placebo response. FDA submission for adult/adolescent HS is slated for September 2026; psoriatic arthritis topline data arrives mid-2026.
1. HS Trial Outcomes
MoonLake’s two late-stage hidradenitis suppurativa trials enrolled approximately 838 patients each and delivered mixed 16-week topline data, with one study meeting its primary endpoint and the other narrowly missing due to an elevated placebo response that affected statistical comparisons.
2. Upcoming 52-Week Data & FDA Plans
Full 52-week outcomes are slated for release in Q2 2026; an FDA submission for adult/adolescent HS is planned by September 2026, with potential Priority Review by November and a U.S. launch targeted for the second half of 2027.
3. Psoriatic Arthritis Trials
The company is also running two late-stage sonelokimab trials in psoriatic arthritis, with primary data readouts expected in mid-2026 and late-2026, aiming to broaden the drug’s label into inflammatory joint disease.
4. Retail Sentiment & M&A
Retail investors have shifted to bullish sentiment on MoonLake stock ahead of pivotal data releases, while speculation continues that Merck or other large pharma could pursue acquisition following earlier buyout approaches.
