MoonLake Advances Sonelokimab After Positive FDA Feedback

MoonLake Immunotherapeutics ( (MLTX) ) has provided an update.

On January 8, 2026, MoonLake Immunotherapeutics reported that a recent Type B meeting with the U.S. Food and Drug Administration delivered positive regulatory feedback on the clinical evidence package for sonelokimab in hidradenitis suppurativa, confirming that the company may pursue a Biologics License Application in the second half of 2026 without conducting additional HS clinical trials. The FDA agreed that data from MoonLake’s existing MIRA, VELA‑1 and VELA‑2 studies—together enrolling more than 1,000 HS patients and showing significant efficacy and a favorable safety profile—can collectively establish substantial evidence of effectiveness, while emphasizing the inclusion of VELA‑2 primarily to inform safety, a stance that reinforces the value of the current HS program and de-risks the regulatory path. The company said preparations for the BLA submission remain on track and highlighted a catalyst-heavy 2026, including multiple Phase 2 and Phase 3 data readouts in axial spondyloarthritis, psoriatic arthritis and adolescent HS, alongside an Investor Day set for February 23, 2026 to discuss the FDA feedback, new clinical data and its broader development roadmap for sonelokimab.

The most recent analyst rating on (MLTX) stock is a Hold with a $13.50 price target. To see the full list of analyst forecasts on MoonLake Immunotherapeutics stock, see the MLTX Stock Forecast page.

Spark’s Take on MLTX Stock

According to Spark, TipRanks’ AI Analyst, MLTX is a Neutral.

The score is held back primarily by pre-revenue status with sharply widening losses and substantial ongoing cash burn, despite a relatively supportive balance sheet. Technicals are mixed/neutral, while valuation is constrained by negative earnings and no dividend. Offsetting these risks, recent clinical progress and stated cash runway into 2H 2027 provide a meaningful but not decisive positive.

To see Spark’s full report on MLTX stock, click here.

More about MoonLake Immunotherapeutics

MoonLake Immunotherapeutics is a clinical-stage biopharmaceutical company headquartered in Zug, Switzerland, developing sonelokimab, a novel investigational Nanobody-based therapy targeting IL‑17A and IL‑17F for inflammatory diseases. Its pipeline focuses on conditions with significant unmet medical need, including hidradenitis suppurativa, psoriatic arthritis, axial spondyloarthritis, palmoplantar pustulosis and adolescent HS, where improved treatment options are in high demand among dermatology and rheumatology patients worldwide.

Average Trading Volume: 2,453,345

Technical Sentiment Signal: Sell

Current Market Cap: $797.2M

Find detailed analytics on MLTX stock on TipRanks’ Stock Analysis page.