MoonLake pushes sonelokimab toward FDA approval for a painful skin disease

Overview

Updated Jun 23

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.

One-year Phase 3 results show 67.2% of patients cut their abscess counts by at least 75%, and 33.1% reached complete clearance. MoonLake plans to file a biologics license application (BLA) with the FDA by end of September 2026, with FDA acceptance and a PDUFA review date expected by end of November. A U.S. commercial launch is targeted for the second half of 2027; the company also proposed a $150 million share offering on June 22 to fund the push.

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

FDA acceptance expected

By end of November, MoonLake expects the FDA to notify it whether the BLA was accepted and to assign a PDUFA review date, following the September filing.

Voices

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People Involved

Jorge Santos da Silva

Co-founder and Chief Executive Officer, MoonLake Immunotherapeutics

Leading the company's first push for FDA approval

Kristian Reich

Co-founder and Chief Scientific Officer, MoonLake Immunotherapeutics

Guiding the clinical case for sonelokimab

Organizations Involved

MoonLake Immunotherapeutics

Clinical-stage biotechnology company

Targeting BLA submission by end-September 2026; proposed $150 million equity offering on June 22 to fund commercialization

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

Timeline

September 2015 June 2026

8 events Latest: June 22nd, 2026 · 3 months ago

Tap a bar to jump to that date

June 2026
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.
June 22nd, 2026
Investor day sets September BLA deadline and H2 2027 launch target
Company

MoonLake set a BLA submission deadline of end-September 2026, with FDA acceptance and a PDUFA review date expected by end of November. The proposed label covers adults and adolescents aged 12 and above; Priority Review, if granted, could pull the launch forward by roughly one quarter.
June 22nd, 2026 • 1:00 PM
MoonLake proposes $150 million equity offering
Financial

MoonLake announced a proposed offering of $150 million in Class A ordinary shares, with underwriters holding a 30-day option for an additional $22.5 million, to fund pre-commercialization activities and the BLA filing.
June 22nd, 2026
March 2026
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.
March 2026
November 2024
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.
November 2024
October 2023
Cosentyx clears for HS
Regulatory

The FDA approves Novartis's Cosentyx (secukinumab), an IL-17A blocker, giving patients a second class of biologic.
October 2023
2021
MoonLake founded
Company

Jorge Santos da Silva and Kristian Reich start MoonLake to develop sonelokimab for inflammatory diseases.
2021
September 2015
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.
September 10th, 2015

Scenarios

FDA approves sonelokimab for hidradenitis suppurativa

Likely Resolves by Q2 2027

Discussed by: MoonLake; biotech trade press including BioSpace and RTTNews

MoonLake files its application and the FDA grants Priority Review, then clears sonelokimab for moderate-to-severe HS. The strong one-year clearance rates and clean safety record carry the application. Approval gives patients a new injected option and lets MoonLake start selling its first product.

FDA delays decision or issues a complete response letter

Possible Resolves by Q2 2027

Discussed by: Regulatory analysts; FDA review precedent

The FDA asks for more data, flags manufacturing issues, or pushes back its decision date. A complete response letter would not kill the drug but would delay launch by months or longer. Cross-trial comparisons that look favorable on paper carry no weight without head-to-head data, and reviewers may probe the safety database.

A larger drugmaker acquires MoonLake

Uncertain Resolves by End of 2027

Discussed by: Sector M&A watchers; biotech investors tracking MLTX

A single strong product and a pending approval make MoonLake a takeover target. A larger company with a dermatology sales force could buy it to add sonelokimab to its lineup against Bimzelx and Cosentyx. A deal would resolve the launch-execution question by handing it to a buyer with scale.

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.

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.

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.