Nanobody sonelokimab - (IZAR-1)

November 4, 2026: MoonLake Immunotherapeutics (NASDAQ: MLTX) reported a regulatory and clinical update for sonelokimab. In hidradenitis suppurativa, the company submitted a BLA to the FDA on September 30, 2026 seeking approval for moderate-to-severe HS in adults and patients aged 12 and older. MoonLake expects an FDA filing acceptance decision by end-November 2026, a PDUFA goal date by mid-December 2026, and mid-cycle review in H1 2027. VELA-TEEN is expected to complete in Q4 2026, with final results planned for presentation in Q1 2027.

In psoriatic arthritis, Phase 3 IZAR-1 Week 16 results announced in August 2026 met all clinical endpoints for sonelokimab 60 mg with induction; 42.1% of biologic-naïve patients achieved ACR50 at Week 16. Comparative placebo data remain blinded until trial completion. IZAR-2 completed enrollment in September 2026, with initial Week 16 topline results expected in Q1 2027 and Week 52 results in Q4 2027. IZAR-1 Week 52 topline results are expected in Q2 2027. P-OLARIS results are expected in early 2027.

In palmoplantar pustulosis, Phase 3 NOVA remains on track to begin enrollment in November 2026.

MoonLake ended Q3 2026 with $498.5 million in cash, cash equivalents and short-term marketable debt securities, with runway projected to mid-2028.