MoonLake’s Psoriatic Arthritis Drug Shows Promise In Phase 3 Trial – Retail Shrugs Off Premarket Slide, Says ‘Pipeline Is Intact’

At week 16, 42.1% of patients on Sonelokimab achieved at least a 50% improvement in psoriatic arthritis symptoms, meeting the trial’s primary endpoint.

• The IZAR-1 trial will continue through Week 52, with full results expected in the first half of 2027.
• Among patients with skin involvement, 61% of patients showed at least a 90% improvement in psoriasis severity.
• MoonLake posted a Q2 loss of $0.84 per share, narrower than Wall Street’s expected loss of $0.93 per share, according to Fiscal.ai data.

MoonLake Immunotherapeutics (MLTX) was in the spotlight in pre-market trading on Monday, after the biotech firm reported positive topline results from a Phase 3 trial of its psoriatic arthritis treatment, along with a narrower -than-expected second-quarter loss.

MoonLake’s Phase 3 IZAR-1 trial tested Sonelokimab in adults with active psoriatic arthritis who had not previously received biologic treatments. The study met all clinical endpoints at Week 16 for the 60 mg dose with induction.

Phase 3 Trial Meets Key Goals

The trial’s primary endpoint was ACR50, which measures whether patients achieve at least a 50% improvement in signs and symptoms of psoriatic arthritis. At week 16, 42.1% of patients treated with Sonelokimab achieved that response.

The drug showed improvements across other measures. About 66.5% of patients achieved ACR20, while 41.2% reached minimal disease activity. Among patients with skin involvement, 61% achieved PASI90, indicating at least a 90% improvement in psoriasis severity.

MoonLake also reported significant improvements in measures of physical function and patients’ overall physical health. Meanwhile, the drug’s safety profile was consistent with previous studies.

However, MLTX shares dropped 7% in pre-market trading.

What’s Next For MLTX?

Detailed comparisons against placebo remain blinded and will be disclosed after completion of the Phase 3 program. IZAR-1 will continue through week 52, with full results expected in the first half of 2027.

The company also expects to submit a U.S. marketing application for Sonelokimab in hidradenitis suppurativa by the end of September. Hidradenitis Suppurativa is a type of condition that causes painful, swollen lumps under the skin.

MoonLake’s Funds To Support Operations Into Mid 2028

The firm posted a quarterly loss of $0.84 per share, which was narrower than Wall Street’s expected loss of $0.93 per share, according to Fiscal.ai data. It is a pre-revenue company.

MoonLake ended the second quarter with $537 million in cash and investments, which is expected to fund operations into mid-2028.

MLTX Traders Mixed On Phase 3 Data

Despite the pre-market sell-off, retail sentiment surrounding MLTX on Stocktwits remained ‘bullish’ over the past 24 hours, amid ‘high’ message volumes.

One user said the data didn’t justify the pre-market fall, adding that “The science is intact. The pipeline is intact.”

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However, another user noted that there are other effective therapies.

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The stock has seen significant buying interest so far this year, gaining around 50%.

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