MoonLake Plans September FDA Submission for Sonelokimab in Hidradenitis Suppurativa
MoonLake Immunotherapeutics plans to submit an FDA Biologics License Application for Sonelokimab in hidradenitis suppurativa by the end of September following a positive pre-BLA meeting. The submission is supported by clinical trial data showing 43% of patients achieved high-level improvement by Week 12 in the Mira trial. The company is also expecting multiple Phase 3 data readouts throughout the year.
MoonLake Immunotherapeutics plans to submit its Biologics License Application (BLA) for the drug Sonelokimab in hidradenitis suppurativa to the U.S. Food and Drug Administration by the end of September. The company recently reported a positive outcome from its final pre-BLA meeting with the FDA, where it aligned on submission plans, label strategy, and safety data requirements. Acceptance and a decision on Priority Review designation are expected by the end of November.
The submission plans follow positive clinical data and analyst activity. The proposed label is expected to include data from the Mira trial, where 43% of patients treated with Sonelokimab achieved a high level of disease improvement by Week 12. The drug also outperformed placebo by about 29 percentage points. In an open-label study of patients with axial spondyloarthritis, 77% of patients saw an improvement in symptoms within four weeks after just two doses, and more than half hit partial remission by Week 12.
The company is expecting 52-week data from the Phase 3 Vela-1 and Vela-2 hidradenitis suppurativa studies in the second quarter. It is also awaiting primary endpoint readouts from the Phase 3 Izar-1 and Izar-2 trials in psoriatic arthritis, as well as results from the Phase 3 Vela-Teen study in adolescent hidradenitis suppurativa patients. The FDA has granted Fast Track designation for Sonelokimab.
Analyst ratings on the stock are varied. H.C. Wainwright reiterated its 'Buy' rating and $45 price target, implying a 150% upside. RBC Capital maintained a 'Hold' rating and set a price target of $12.00. The consensus average target price from analysts is $23.86, suggesting a potential upside of 30.22% from its current trading level. The stock is currently trading around $18.
Financially, MoonLake Immunotherapeutics reported a quarterly GAAP net loss of $69.73 million for the quarter ending September 30, compared to a loss of $35.39 million the prior year. The company has a market capitalization of $1.31 billion and a negative earnings per share of -3.53. Corporate insider sentiment is negative, with the CEO selling 200,000 shares in December 2025 for a total of $2,974,700.