USFDAMay 11, 2026, 07:11 AM
MoonLake Aligns with FDA on SLK BLA for HS; Q1 Results
AI Summary
MoonLake Immunotherapeutics announced a positive outcome from its final pre-BLA meeting with the FDA for sonelokimab (SLK) in hidradenitis suppurativa (HS), aligning on submission plans and label strategy, including data from MIRA and VELA-TEEN trials. The company plans to submit the BLA by the end of September 2026 and expects a decision on Priority Review by end of November 2026. Additionally, MoonLake reported $357.9 million in cash, cash equivalents, and short-term marketable debt securities for Q1 2026, with a cash runway expected until the end of 2027.
Key Highlights
- MoonLake Immunotherapeutics aligned with the FDA on submission plans and label strategy for sonelokimab (SLK) in hidradenitis suppurativa (HS).
- The BLA submission for SLK in adult and adolescent HS is planned for the end of September 2026.
- Acceptance of the BLA and a decision on Priority Review designation are expected by the end of November 2026.
- MoonLake ended Q1 2026 with $357.9 million in cash, cash equivalents, and short-term marketable debt securities.
- The company expects to have a cash runway until the end of 2027.
- Research and development expenses were $54.5 million for the three months ended March 31, 2026.
- General and administrative expenses were $15.5 million for the three months ended March 31, 2026.
- Net loss for Q1 2026 was $(69.7) million, or $(0.98) per share.
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