MoonLake's Nanobody drug clears its second Phase 3 test
New CapabilitiesSonelokimab met its main goal in psoriatic arthritis, adding a second disease to a filing path already moving in hidradenitis suppurativa
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Overview
MoonLake's experimental drug sonelokimab hit its main goal in a second late-stage trial, this time in psoriatic arthritis. The win moves the small Swiss biotech's Nanobody drug closer to two separate markets.
Psoriatic arthritis is a painful joint disease tied to the skin condition psoriasis. Sonelokimab is built differently from the antibodies doctors use now: it blocks two inflammation signals at once and latches onto albumin to concentrate in swollen tissue. Analysts have said a clean readout could make MoonLake a takeover target worth $8 billion to $10 billion.
Why it matters
A second Phase 3 win moves a novel Nanobody drug toward market and makes MoonLake a likely takeover target for large drugmakers.
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A Zug, Switzerland biotech built around one drug, the tri-specific Nanobody sonelokimab, for inflammatory diseases.
The US agency that decides whether sonelokimab can be sold, starting with the hidradenitis suppurativa application.
Timeline
November 2024 August 2026
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IZAR-1 meets all goals in psoriatic arthritis
Today Clinical TrialThe 60 mg dose meets the ACR50 primary endpoint and every secondary goal at Week 16. Blinded safety matches earlier studies.
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One-year skin-disease data hold up
Clinical TrialWeek 52 VELA results show 67.2% of hidradenitis suppurativa patients reach HiSCR75 and 33.1% reach HiSCR100, with no new safety signals.
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FDA aligns with MoonLake on filing path
RegulatoryA positive Type B meeting with the FDA sets up the planned hidradenitis suppurativa application and lifts the stock.
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MoonLake launches Phase 3 in psoriatic arthritis
Clinical TrialThe two-trial IZAR program begins. IZAR-1 studies biologic-naive patients; IZAR-2 tests harder-to-treat patients against AbbVie's risankizumab.
Historical Context
3 moments from history that rhyme with this story — and how they unfolded.
Merck buys Prometheus Biosciences (2023)
Merck agreed to pay about $10.8 billion for Prometheus Biosciences, a clinical-stage biotech with a late-stage immune-disease antibody. The price was a 75% premium on Prometheus's share price.
The deal closed later in 2023, one of the year's biggest biotech acquisitions.
It set a benchmark for what large drugmakers will pay for de-risked immunology assets to refill pipelines.
It shows the price range MoonLake could command, and why analysts see a sale as a live outcome once late-stage data land.
UCB's Bimzelx delayed by FDA (2022–2023)
UCB's bimekizumab, the first dual IL-17A and IL-17F antibody, had strong efficacy data but received a Complete Response Letter from the FDA in 2022 tied to a manufacturing inspection, not the drug's benefit.
US approval was pushed to October 2023 for plaque psoriasis.
Bimekizumab went on to win approval in psoriatic arthritis and other conditions and became a growing seller for UCB.
It is the closest match to sonelokimab's mechanism and a reminder that clean trials do not guarantee an on-time approval.
Novartis launches Cosentyx (2016)
Novartis won US approval for secukinumab (Cosentyx) in psoriatic arthritis, the first IL-17A inhibitor cleared for the disease, based on the FUTURE trials.
Cosentyx expanded across psoriasis and spondyloarthritis indications.
It grew into a multibillion-dollar franchise, proving the commercial ceiling for IL-17 drugs in these diseases.
It marks the market sonelokimab is entering and the incumbent revenue a newer, dual-signal drug would try to take share from.
