Analysts raised MLTX’s price target after the company confirmed FDA alignment on its sonelokimab BLA submission strategy.
H.C. Wainwright increased its price target for MoonLake Immunotherapeutics (NASDAQ:MLTX) to $45 from $40, maintaining a Buy rating. The adjustment follows regulatory progress for sonelokimab, the company’s nanobody therapy for hidradenitis suppurativa, after positive pre-application discussions with the FDA.
MoonLake confirmed alignment with the FDA on its biologics license application (BLA) submission strategy, labeling approach, and data from the MIRA and VELA-TEEN studies. The BLA filing is scheduled for late September 2026, with potential FDA acceptance by November 2026. The company also reported advancement in Phase 3 studies for psoriatic arthritis.
The revised target reflects confidence in the therapy’s clinical development and regulatory pathway, though no immediate market reaction was disclosed.