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MoonLake pushes sonelokimab toward FDA approval for a painful skin disease

MoonLake pushes sonelokimab toward FDA approval for a painful skin disease

New Capabilities

One-year Phase 3 data show high clearance rates as the biotech files for U.S. approval in hidradenitis suppurativa

Yesterday: One-year Phase 3 results reported

Overview

Hidradenitis suppurativa causes painful, recurring abscesses in the skin folds of about 1 in 100 people. For most of the past decade, one drug controlled it well enough to win U.S. approval. MoonLake now wants to change that.

On June 22, 2026, the Swiss-American biotech reported that 67.2% of patients in its two Phase 3 trials cut their abscess and nodule counts by at least 75% after a year on sonelokimab, an injected antibody. Complete clearance reached 33.1%. The company is filing for U.S. approval and asking the FDA for a faster review.

Why it matters

Hidradenitis suppurativa is painful, common, and badly served by existing drugs; a more effective option could move many patients from severe symptoms to mild.

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Key Indicators

67.2%
Reached HiSCR75 at one year
Share of patients who cut abscess and inflammatory-nodule counts by at least 75%.
33.1%
Complete clearance (HiSCR100)
Patients with no remaining abscesses or inflammatory nodules at Week 52.
-15.0
Quality-of-life score change
Average HiSQOL improvement, roughly a shift from 'severe' to 'mild' impact.
~1%
Population with the disease
Hidradenitis suppurativa affects roughly 1% of people, often starting in early adulthood.
Nov 2026
Expected FDA decision window
Company target for a regulatory decision under requested Priority Review.

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People Involved

Jorge Santos da Silva
Jorge Santos da Silva
Leading the company's first push for FDA approval
KR
Kristian Reich
Guiding the clinical case for sonelokimab

Organizations Involved

MoonLake Immunotherapeutics
MoonLake Immunotherapeutics
Clinical-stage biotechnology company
Filing sonelokimab for U.S. approval in hidradenitis suppurativa

A Swiss-American biotech built around one drug, sonelokimab, for inflammatory skin and joint diseases.

Timeline

September 2015 June 2026

6 events Latest: Yesterday
Tap a bar to jump to that date

  1. One-year Phase 3 results reported

    Latest Clinical

    Across the VELA-1 and VELA-2 trials, 67.2% of patients hit HiSCR75 and 33.1% reached complete clearance at Week 52, with no new safety problems. MoonLake confirms it will file for FDA approval and request Priority Review.

  2. Week 40 data shown at AAD

    Clinical

    MoonLake presents 40-week VELA results at the American Academy of Dermatology annual meeting, setting up the one-year readout.

  3. Bimzelx clears for HS

    Regulatory

    UCB's Bimzelx (bimekizumab), which blocks both IL-17A and IL-17F, wins U.S. approval and becomes sonelokimab's closest rival.

  4. Cosentyx clears for HS

    Regulatory

    The FDA approves Novartis's Cosentyx (secukinumab), an IL-17A blocker, giving patients a second class of biologic.

  5. MoonLake founded

    Company

    Jorge Santos da Silva and Kristian Reich start MoonLake to develop sonelokimab for inflammatory diseases.

  6. First drug approved for hidradenitis suppurativa

    Regulatory

    The FDA approves AbbVie's Humira (adalimumab), the first medicine cleared for moderate-to-severe HS. Before it, patients relied on antibiotics and surgery.

Historical Context

3 moments from history that rhyme with this story — and how they unfolded.

September 2015

First HS drug approved (2015)

The FDA approved AbbVie's Humira for moderate-to-severe hidradenitis suppurativa. It was the first medicine cleared for the disease. Until then, patients had antibiotics and surgery to remove affected skin.

Then

Humira gave doctors a systemic drug to slow flares, though many patients still saw limited relief.

Now

It set the disease's first regulatory benchmark and showed that blocking inflammatory signals could help, opening the field to newer drugs.

Why this matters now

Sonelokimab is measured against the bar Humira set a decade ago. Its higher clearance rates are the case for why a new drug is needed.

October 2023 to November 2024

IL-17 blockers enter HS (2023-2024)

The FDA approved Novartis's Cosentyx, which blocks IL-17A, then UCB's Bimzelx, which blocks both IL-17A and IL-17F. Both target the inflammation pathway sonelokimab also hits.

Then

Patients gained two new biologic options after years with essentially one.

Now

The approvals turned HS into a competitive market and made dual IL-17A/F blocking the benchmark to beat.

Why this matters now

Bimzelx is sonelokimab's closest rival. MoonLake's pitch is that its drug clears skin better, but no head-to-head trial exists to prove it.

March 2017

Dupixent reshapes atopic dermatitis (2017)

The FDA approved Sanofi and Regeneron's Dupixent for moderate-to-severe atopic dermatitis. The drug treated a common, long-neglected skin disease far better than older options and grew into a multibillion-dollar product.

Then

Patients with severe eczema gained a treatment that cleared skin and cut itch for many.

Now

Dupixent showed that a well-targeted biologic can transform a neglected dermatology market and reward the company behind it.

Why this matters now

It is the model MoonLake hopes to follow: a strong drug in an underserved skin disease can build a large market if it reaches patients.

Sources

(6)
GlobeNewswire BioSpace RTTNews American Journal of Managed Care AbbVie PharmaBoardroom