MoonLake Immunotherapeutics: HS Regulatory De-Risking and 2026 Inflammatory Disease Catalysts Support Buy Rating

Needham analyst Serge Belanger maintained a Buy rating on MoonLake Immunotherapeutics today and set a price target of $20.00.

Serge Belanger has given his Buy rating due to a combination of factors tied to MoonLake’s progress with solenokinumab (SLK) in hidradenitis suppurativa (HS). Following a recent Type B meeting, the FDA indicated that the current data package from the MIRA, VELA-1, and VELA-2 studies can be sufficient to support a biologics license application, allowing the company to proceed toward a planned filing in the second half of 2026 without running another large trial. This regulatory stance reduces prior uncertainty that had arisen after the Phase 3 VELA results and represents a more streamlined path to market than historically required for similar drugs. Belanger views this as a meaningful de-risking of the SLK/HS program and supportive of the firm’s $20 price target.

At the same time, he acknowledges that SLK’s commercial opportunity in HS may be somewhat more modest than initially envisioned before the VELA readouts, but still sees a viable approval path and revenue contribution from this indication. Importantly, he highlights additional upside from a series of upcoming readouts in 2026 across other inflammatory diseases, including axial spondyloarthritis (axSpA), psoriatic arthritis (PsA), and palmoplantar pustulosis (PPP). In these areas, SLK may be able to show strong efficacy combined with a favorable safety and tolerability profile versus existing options, potentially broadening the drug’s market potential. Taken together, the clearer regulatory trajectory in HS and the optionality from multiple future catalysts underpin his decision to maintain a Buy rating on MoonLake Immunotherapeutics.

In another report released today, Clear Street also maintained a Buy rating on the stock with a $45.00 price target.

Based on the recent corporate insider activity of 18 insiders, corporate insider sentiment is negative on the stock. This means that over the past quarter there has been an increase of insiders selling their shares of MLTX in relation to earlier this year.