Overview
- One Phase 3 study showed about 35% of patients on sonelokimab achieved a symptom reduction at four months versus roughly 18% on placebo, a statistically significant but smaller-than-expected effect.
- A second late-stage trial failed its primary endpoint, which the company attributed to an unexpectedly high placebo response.
- Moonlake said pooled data across both studies demonstrated clinically meaningful and statistically significant improvement and plans to discuss analytical strategies with regulators.
- The stock dropped more than 80% to below $10 as multiple analysts labeled the results disappointing and cast doubt on near-term approval and sales potential.
- Recent approvals of Novartis’ Cosentyx and UCB’s Bimzelx have heightened competitive pressure, with RBC calling sonelokimab’s effect size uncompetitive.