Biologics License Application for sonelokimab submitted to the U.S. Food and Drug Administration for the treatment of adults and adolescents with moderate-to-severe hidradenitis suppurativa, marking an important step
Phase 3 IZAR-1 trial in bio-naïve patients met all clinical endpoints at Week 16 for 60 mg sonelokimabThe primary endpoint of ACR50 was met with a high response of 42.1% for sonelokimab’s 60 mg with induction, and
ZUG, Switzerland, June 23, 2026 – MoonLake Immunotherapeutics (NASDAQ:MLTX) ("MoonLake"), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory skin and joint diseases,
ZUG, Switzerland, June 22, 2026 – MoonLake Immunotherapeutics (NASDAQ:MLTX) ("MoonLake"), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory skin and joint diseases,
Results from the Phase 3 VELA clinical trials at Week 52 in adults with moderate-to-severe hidradenitis suppurativa (HS) demonstrate sonelokimab’s (SLK) potential best-in-class and best-in-disease profile, with
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
Results from the Phase 3 VELA clinical trials in adults with moderate-to-severe hidradenitis suppurativa (HS) show that clinical responses continue to improve to Week 40, with 62% of patients treated with sonelokimab
In the Phase 2 S-OLARIS clinical trial in axial spondyloarthritis (axSpA), sonelokimab (SLK) demonstrated clinically meaningful benefit with 80+% of patients achieving ASAS40 by Week 12Consistently, other clinical and
Brings 20+ years of clinical development experience in autoimmune and inflammatory diseases, including OX40/OX40L program leadership Will build and lead Imagene's clinical organization and drive completion of the Phase
The Dermatology Division of the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to sonelokimab (SLK) in moderate-to-severe palmoplantar pustulosis (PPP) supported by positive results from the
DENVER, Jan. 08, 2026 (GLOBE NEWSWIRE) -- Markets head into the session with a familiar but powerful theme in focus: enabling technologies that quietly unlock the next wave of growth. From satellite connectivity at
MoonLake requested a Type B meeting with the U.S. Food and Drug Administration (FDA) to obtain regulatory clarity and discuss the clinical evidence strategy for submission of a Biologic License Application (BLA) for
NEW YORK, Dec. 15, 2025 (GLOBE NEWSWIRE) -- Levi & Korsinsky, LLP notifies investors in MoonLake Immunotherapeutics ("MoonLake" or the "Company") (NASDAQ:MLTX) of a class action securities lawsuit.
SAN FRANCISCO, Dec. 15, 2025 /PRNewswire/ -- Global plaintiffs' rights firm Hagens Berman reminds investors that the Lead Plaintiff Deadline in the securities class action lawsuit against MoonLake Immunotherapeutics
