MoonLake Immunotherapeutics announces positive outcome from Type B meeting with U.S. FDA regarding the clinical evidence strategy for Sonelokimab in Hidradenitis Suppurativa (HS).
FDA feedback confirms the Company's ability to establish substantial evidence of effectiveness with existing trials for Sonelokimab in HS.
MoonLake plans to continue BLA submission for Sonelokimab in HS in the second half of 2026 and to hold an Investor Day on February 23rd, 2026.
Sonelokimab showed significant improvements in over 1,000 patients with HS across MIRA, VELA-1, and VELA-2 trials, demonstrating positive results.
MoonLake received clear FDA feedback on the relevance of MIRA and VELA trials for BLA submission for Sonelokimab in HS.
FDA Feedback
Confirms MoonLake's ability to establish SEE for Sonelokimab in HS without additional trials.
BLA Submission Plans
MoonLake to continue BLA submission for Sonelokimab in HS in H2 2026.
Investor Day Announcement
MoonLake to hold an Investor Day on February 23rd, 2026 to discuss FDA feedback and value opportunities for Sonelokimab in HS.
Clinical Trial Results
Sonelokimab showed significant improvements across MIRA, VELA-1, and VELA-2 trials in over 1,000 HS patients.
Regulatory Clarity
FDA feedback supports MoonLake's perspective on the relevance of MIRA and VELA trials for Sonelokimab BLA submission.
- The positive outcome of the Type B meeting provides MoonLake with clarity and support for its pathway to approval for the HS program without the need for additional clinical trials.
- FDA feedback allows MoonLake to prepare the BLA with existing trial data, providing flexibility for the best label possible for Sonelokimab.
- MoonLake's ability to establish SEE for Sonelokimab in HS based on existing trials strengthens the foundation for broader development in other indications.
The positive outcome from the Type B meeting and clear FDA feedback validate MoonLake's approach to submitting the BLA for Sonelokimab in HS. This marks a significant step towards potential approval and broader development opportunities for the Company.