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MoonLake Immunotherapeutics Announces Positive Outcome from its Final Pre-BLA Meeting with the U.S. FDA and Reports First Quarter 2026 Financial Results

MoonLake Immunotherapeutics (MLTX)MoonLake ImmunotherapeuticsFDA / regulatory

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

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MoonLake Immunotherapeutics

Nanobody-Based Immunology MoonLake Immunotherapeutics develops therapies for inflammatory diseases using Nanobodies, compact antibody-derived proteins designed for tissue penetration, molecular stability and multivalent target binding. Sonelokimab Sonelokimab is a trivalent Nanobody that binds IL-17A and IL-17F while also interacting...

Recent company news

MLTXMoonLake Immunotherapeutics2026-08-10 11:00 EST

MoonLake Announces Positive Topline Results from the Phase 3 IZAR-1 Trial of Sonelokimab in Psoriatic Arthritis Demonstrating Significant Improvements Across all Clinical Endpoints, and Reports Second Quarter 2026 Financial Results

MLTXMoonLake Immunotherapeutics2026-06-24 03:08 EST

MoonLake Immunotherapeutics Announces Pricing of Upsized $200 Million Public Offering

MLTXMoonLake Immunotherapeutics2026-06-22 20:01 EST

MoonLake Immunotherapeutics Announces Proposed Public Offering

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MoonLake Announces Week 52 Results of Sonelokimab from its Phase 3 VELA Program in Hidradenitis Suppurativa and Confirms Investor Day on June 22, 2026

MLTXMoonLake Immunotherapeutics2026-05-10 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

Stock data

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11.47 USD
Market cap
1.32B USD
Exchange
NASDAQ
Sector
Biopharma
Location
United States