MoonLake Immunotherapeutics

MoonLake Immunotherapeutics has submitted a Biologics License Application to the US FDA seeking approval of sonelokimab for hidradenitis suppurativa. The company has completed two phase 3 studies of the tri-specific nanobody in adults, VELA-1 and VELA-2, and also has the phase 3 VELA-TEEN trial for adolescent patients. Sonelokimab binds with high affinity to the cytokines IL-17A and IL-17F, is administered via subcutaneous injection, and is given every four weeks. If approved, sonelokimab will likely compete against UCB's Bimzelx, also known as bimekizumab. Hidradenitis suppurativa is an inflammatory skin condition characterized by boil-like lumps.

MoonLake Immunotherapeutics received a reiterated Buy rating and $70 price target from Clear Street, with the firm highlighting the competitive profile of sonelokimab in hidradenitis suppurativa and a significant commercial opportunity. The Biologics License Application submission remains expected by September 30, and management continues to view the possibility of priority review. Separately, the company priced an underwritten public offering of 9 million Class A ordinary shares at $20.00 per share and pre-funded warrants for up to 1 million additional shares at $19.9999 per warrant, expected to generate approximately $200 million in gross proceeds before fees and expenses. Underwriters have a 30-day option to purchase an additional 1.5 million Class A ordinary shares. Proceeds will support research, development, pre-commercialization, and commercialization activities for sonelokimab, if approved, and general corporate purposes.

MoonLake Immunotherapeutics announced positive 52-week results from its Phase 3 VELA-1 and VELA-2 trials of sonelokimab in moderate-to-severe hidradenitis suppurativa, sending shares up 10.26% to $21.18 in overnight trading. Across both trials, 67.2% of patients achieved HiSCR75 and 33.1% achieved HiSCR100 at week 52, with 26.0% reaching an IHS4-100 response indicating inflammatory remission. The company said the safety profile remained consistent with no new signals. A Biologics License Application submission is expected by the end of September 2026, with FDA filing acceptance anticipated around November 2026.