MoonLake’s Sonelokimab Delivers 62% HiSCR75 Week 40 But Stock Plunges 88%

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MoonLake’s sonelokimab showed 62% HiSCR75 and 32% HiSCR100 at week 40 with 25% inflammatory remission and QoL improvements of 41-62%. Despite these results, MLTX shares plunged 88% after failing to surpass Bimzelx in week-16 efficacy.

1. VELA-1 and VELA-2 Efficacy Results

In two Phase III trials, VELA-1 and VELA-2, 62% of patients achieved HiSCR75 and 32% reached HiSCR100 at week 40. Sonelokimab also induced complete inflammatory remission in 25% of treated patients, clearing abscesses, nodules and draining tunnels.

2. Quality of Life and Safety Findings

Patients receiving sonelokimab reported improvements in pain by 41%, mobility and dressing by 54%, and mental wellbeing by 62% at week 40 versus baseline. No new safety signals emerged, confirming long-term tolerability of the nanobody therapy.

3. Investor Reaction and Stock Impact

MLTX shares dropped 88% following the initial data release due to sonelokimab’s inability to outperform Bimzelx in week-16 efficacy. The steep decline reflects investor skepticism over commercial competitiveness despite durable 40-week results.

4. Future Outlook and Market Potential

The VELA programme will continue through 52 weeks, with full data expected in Q2 2026 and an approval filing planned for H2 2026. MoonLake aims to target a projected $7.8 billion HS market by 2034 and explore additional indications such as psoriatic arthritis and psoriasis.

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