USFDAMay 10, 2026, 09:02 AM
MoonLake Aligns with FDA on Sonelokimab BLA for HS; Q1 Net Loss $(69.7M)
AI Summary
MoonLake Immunotherapeutics announced a positive 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 end of September 2026, with a decision on Priority Review expected by end of November 2026, and a potential US launch in H2 2027. For Q1 2026, MoonLake reported a net loss of $(69.7) million and ended the quarter with $357.9 million in cash, expecting a cash runway until the end of 2027.
Key Highlights
- Positive final pre-BLA meeting with FDA for sonelokimab (SLK) in hidradenitis suppurativa (HS).
- BLA submission for SLK in HS planned for end of September 2026.
- FDA decision on Priority Review for HS BLA expected by end of November 2026.
- Proposed HS label expected to include MIRA trial's ~43% HiSCR75 response.
- Q1 2026 net loss was $(69.7) million, compared to $(63.0) million in Q4 2025.
- Cash, cash equivalents, and short-term marketable debt securities totaled $357.9 million as of March 31, 2026.
- Company expects cash runway to fund operations until the end of 2027.
- Q1 2026 R&D expenses were $54.5 million; G&A expenses were $15.5 million.