# MoonLake Immunotherapeutics Announces Positive Outcome from its Final Pre-BLA Meeting with the U.S. FDA and Reports First Quarter 2026 Financial Results
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Ticker: MLTX
Company: MoonLake Immunotherapeutics
Source: MoonLake Immunotherapeutics
Published: 2026-05-10 13:00 EST
Original Source URL: https://ir.moonlaketx.com
## Summary

MoonLake conducted a positive final pre-BLA (Biologics License Application) meeting with the U.S. Food and Drug Administration (FDA), where MoonLake and the FDA aligned on submission plans and the label strategy for sonelokimab (SLK) in hidradenitis suppurativa (HS) This included the acceptability

## Article Body
MoonLake conducted a positive final pre-BLA (Biologics License Application) meeting with the U.S. Food and Drug Administration (FDA), where MoonLake and the FDA aligned on submission plans and the label strategy for sonelokimab (SLK) in hidradenitis suppurativa (HS) This included the acceptability
## Recent Company News
- 2026-05-10 13:00 EST — [MoonLake Immunotherapeutics Announces Positive Outcome from its Final Pre-BLA Meeting with the U.S. FDA and Reports First Quarter 2026 Financial Results](https://biopharmsignal.com/news/MLTX/moonlake-immunotherapeutics-announces-positive-outcome-from-its-final-pre-bla-meeting-with-the-u-s-fda-and-reports-first-quarter-2026-financial-results) — Source: MoonLake Immunotherapeutics
- 2026-03-28 19:00 EST — [MoonLake announces Week 40 Results from its Phase 3 Clinical Trials of Sonelokimab in Hidradenitis Suppurativa at the 2026 AAD Annual Meeting](https://biopharmsignal.com/news/MLTX/moonlake-announces-week-40-results-from-its-phase-3-clinical-trials-of-sonelokimab-in-hidradenitis-suppurativa-at-the-2026-aad-annual-meeting) — Source: MoonLake Immunotherapeutics
- 2026-02-22 16:00 EST — [MoonLake Announces Positive Topline Results from its Phase 2 Clinical Trial of Sonelokimab in Axial Spondyloarthritis and Reports 2025 Financial Results](https://biopharmsignal.com/news/MLTX/moonlake-announces-positive-topline-results-from-its-phase-2-clinical-trial-of-sonelokimab-in-axial-spondyloarthritis-and-reports-2025-financial-results) — Source: MoonLake Immunotherapeutics
- 2026-02-02 13:00 EST — [MoonLake Announces FDA Fast Track Designation for Sonelokimab Palmoplantar Pustulosis (PPP) and Provides Details on Upcoming Investor Day](https://biopharmsignal.com/news/MLTX/moonlake-announces-fda-fast-track-designation-for-sonelokimab-palmoplantar-pustulosis-ppp-and-provides-details-on-upcoming-investor-day) — Source: MoonLake Immunotherapeutics
- 2026-01-08 13:00 EST — [MoonLake Immunotherapeutics Announces Positive Outcome from Type B Meeting with U.S. FDA and Announces Investor Day](https://biopharmsignal.com/news/MLTX/moonlake-immunotherapeutics-announces-positive-outcome-from-type-b-meeting-with-u-s-fda-and-announces-investor-day) — Source: MoonLake Immunotherapeutics
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