Sonelokimab

May 10, 2026 — MoonLake Immunotherapeutics AG (NASDAQ: MLTX) reported a positive final pre-BLA meeting (held April 1, 2026) with the U.S. FDA for sonelokimab (SLK) in hidradenitis suppurativa (HS) and released Q1 2026 financial results. The FDA aligned with MoonLake on BLA submission plans and proposed HS label strategy, including: acceptability of Phase 2 MIRA data as part of “substantial evidence of effectiveness”; inclusion of Phase 3 VELA-TEEN data to support a label for patients aged ≥12 years; and a safety-analysis approach primarily based on VELA-1 and VELA-2, with full inclusion of VELA-2 safety data. No remaining gaps (including CMC) were identified; no further FDA meetings are required pre-submission.

MoonLake expects the proposed HS label to include MIRA’s ~43% HiSCR75 response and ~29 percentage-point delta vs placebo at week 12. BLA submission is planned for end of September 2026, with acceptance (and Priority Review decision) expected within 60 days; first U.S. launch is anticipated in 2H 2027, pending approval.

Financially, MoonLake ended Q1 (March 31, 2026) with $357.9M in cash/cash equivalents/short-term debt securities, projects runway to end of 2027, and has access to up to $400M additional non-dilutive funding via a Hercules Capital facility. Net loss was $69.7M (R&D: $54.5M; G&A: $15.5M).