MoonLake Immunotherapeutics Surges 20% on Sonelokimab Phase 3 HS Results
MLTX•MoonLake Immunotherapeutics' shares surged nearly 20% after Sonelokimab Phase 3 data showed 67.2% of hidradenitis suppurativa patients achieved strong response, 33.1% complete clearance and 26% remission at one year, while adolescent results showed 68% response and 45% clearance. The company will file a BLA by end-September with Priority Review request.
1. Sonelokimab Adult Phase 3 VELA Results
MoonLake Immunotherapeutics reported that its one-year Phase 3 VELA trial for Sonelokimab in hidradenitis suppurativa showed 67.2% of patients achieved a strong response, 33.1% complete skin clearance and 26% inflammatory remission, with nearly half of participants reporting reduced skin pain.
2. Adolescent VELA-Teen Study Success
The Phase 3 VELA-Teen study demonstrated that 68% of adolescent patients achieved a strong treatment response and 45% attained complete skin clearance after 24 weeks, with no new safety concerns identified, potentially supporting a broader pediatric treatment label.
3. Regulatory Timeline and Market Reaction
MoonLake plans to submit a Biologics License Application by end-September and request Priority Review, which could accelerate approval by about three months; shares jumped nearly 20% ahead of the company's Investor Day, reflecting investor optimism about a potential 2027 launch.
