MoonLake Immunotherapeutics Submits BLA for Sonelokimab to Treat Hidradenitis Suppurativa
MoonLake Immunotherapeutics (NASDAQ: MLTX) has submitted a Biologics License Application (BLA) with the U.S. Food and Drug Administration seeking approval of sonelokimab, its tri-specific nanobody therapy for hidradenitis suppurativa in adults. The submission is supported by data from two completed phase 3 trials: VELA-1 and VELA-2. The company also has an ongoing phase 3 trial called VELA-TEEN focused on adolescent patients, indicating a broader development strategy for the treatment. This regulatory filing marks a significant milestone in MoonLake's pipeline progress and could position sonelokimab as a potential first-in-class therapy if approved.
Tickers: $MLTX
Topics: biotech clinical trials drug approval