MoonLake Immunotherapeutics Announces Positive Outcome from Type B Meeting with U.S. FDA and Announces Investor Day
- MoonLake requested a Type B meeting with the U.S. Food and Drug Administration (FDA) to obtain regulatory clarity and discuss the clinical evidence strategy for submission of a Biologic License Application (BLA) for Sonelokimab (SLK) in Hidradenitis Suppurativa (HS)
- FDA feedback confirms that the Company may establish substantial evidence of effectiveness (SEE), without additional clinical trials in HS, with a BLA consisting of data from its existing VELA-1, VELA-2 and MIRA trials
- The FDA specifically advised the Company to include the results of the MIRA trial in the submission and to submit the results of the VELA-2 trial for the marketing application to inform the safety profile of SLK, regardless of decisions on its utility in establishing SEE
- Based on the positive final official records of this Type B meeting MoonLake will continue its plans for BLA submission for SLK in HS in H2 2026
- An Investor Day to further discuss FDA feedback and value opportunities for SLK in HS and to share new clinical data, in HS and other indications, will be held on February 23rd, 2026
ZUG, Switzerland, January 8, 2026 – MoonLake Immunotherapeutics (NASDAQ:MLTX) (“MoonLake” or the “Company”), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, today provided an update following the positive feedback received from the U.S. Food and Drug Administration (FDA) regarding the clinical evidence strategy for SLK in HS, based on the Type B meeting requested by MoonLake.
SLK was associated with significant improvements across different key outcomes in over 1,000 patients with HS enrolled in the MIRA, VELA-1 and VELA-2 trials. MIRA was the first placebo-controlled randomized clinical trial in HS using HiSCR75 as the primary endpoint and demonstrated a 43% response with 120mg SLK, and a 29 ppt delta vs placebo (p < 0.001) at week 12. VELA-1 met all primary and key secondary endpoints with statistical significance across all pre-specified analysis strategies (HiSCR75 at Week 16, 35% response with 120mg SLK, delta to placebo of 17ppt, p < 0.001). In VELA-2, using the pre-specified treatment policy strategy, SLK achieved statistical significance (HiSCR75 at Week 16, 36% response with 120mg SLK, delta to placebo of 10ppt, p = 0.033). A higher-than-expected placebo response precluded this study from achieving statistical significance using the primary composite analysis method (delta to placebo of 9%, p=0.053). All trials consistently suggested a favorable safety profile of SLK in HS patients.
To obtain regulatory clarity following the VELA readout and to continue the preparation of the BLA, MoonLake requested a Type B meeting with the FDA. The Company submitted a detailed briefing book with several additional analysis of the VELA data. The FDA indicated that MoonLake may establish substantial evidence of effectiveness (SEE) without additional clinical trials in HS, with an application consisting of data from its existing VELA-1, VELA-2 and MIRA trials. This supports the Company’s perspective regarding the relevance of MIRA results for the HS BLA submission. In addition, the FDA advised the Company that the results of VELA-2 trial should be submitted for the marketing application to inform the safety of SLK, regardless of decisions on its utility in establishing SEE. The FDA further excluded using mechanistic evidence as confirmatory evidence, in combination with results from a single clinical trial, to establish SEE for the HS indication. Based on the final official records of this Type B meeting, MoonLake will continue its planned preparations for BLA submission.
Dr. Jorge Santos da Silva, Founder and Chief Executive Officer at MoonLake Immunotherapeutics, said: “The positive outcome of our Type B meeting with the FDA provides the clarity needed to support a pathway to approval for our existing HS program, with no additional clinical trials required. In addition, the fact that we can prepare the BLA with the wealth of data across the VELA and MIRA trials provides us and the FDA with flexibility to determine the best label possible, so that SLK, if approved, can have the most positive impact for HS patients. Overall, this also provides a strong base for MoonLake to continue the broader development of SLK in other indications.”
Prof. Kristian Reich, Founder and Chief Scientific Officer at MoonLake Immunotherapeutics, said: “The FDA has provided us with clear and helpful feedback indicating that the MIRA and VELA trials, which together enrolled more than 1000 patients with moderate-to-severe HS and tested sonelokimab using similar study designs, provide a basis for BLA submission. The FDA recognizes that MIRA and VELA-1, which met their primary and important key secondary endpoints, together with VELA-2, can be used to establish substantial evidence of effectiveness, and that VELA-2 provides a key source of evidence to inform, for example, the safety of sonelokimab. The encouraging feedback matches our view of the strong performance of sonelokimab in HS across three trials and we are looking forward to further engaging with the FDA prior to the BLA submission.”
The preparations for the submission of the BLA continue as planned and are on track for submission in H2 2026.
The company will hold an Investor Day on February 23rd, 2026 at 8 am EST / 2pm CET, to further discuss the outcomes of this Type B FDA Meeting and to present new clinical data for SLK across indications. The Company will also provide further details on the catalyst calendar for 2026 and beyond. The details for this Investor Day will be announced in due course.
Other clinical trials of SLK are progressing and are expected to support a catalyst-rich roadmap over the next 12 months, including data releases from the Phase 2 S-OLARIS trial in Axial Spondyloarthritis (axSpA) and the Phase 3 IZAR trials in Psoriatic Arthritis (PsA), among others.
Important upcoming anticipated milestones for MoonLake:
- Q1 2026: Primary endpoint readout of the Phase 2 S-OLARIS trial in axSpA
- Q2 2026: 52 weeks data of the VELA-1 and VELA-2 trials in HS
- Mid 2026: Primary endpoint readout of the Phase 3 IZAR-1 trial in PsA
- Mid 2026: Primary endpoint readout of Phase 3 VELA-TEEN trial in adolescent HS
- H2 2026: Submission of a BLA
- H2 2026: Primary endpoint readout of the Phase 3 IZAR-2 trial in PsA
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About MoonLake ImmunotherapeuticsMoonLake Immunotherapeutics is a clinical-stage biopharmaceutical company unlocking the potential of sonelokimab, a novel investigational Nanobody® for the treatment of inflammatory disease, to revolutionize outcomes for patients. Sonelokimab inhibits IL-17A and IL-17F by inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F dimers that drive inflammation. The Company’s focus is on inflammatory diseases with a major unmet need, including hidradenitis suppurativa, psoriatic arthritis, axial spondyloarthritis and palmoplantar pustulosis – conditions affecting millions of people worldwide with a large need for improved treatment options. MoonLake was founded in 2021 and is headquartered in Zug, Switzerland. Further information is available at www.moonlaketx.com.
About Nanobodies®Nanobodies® represent a new generation of antibody-derived targeted therapies. They consist of one or more domains based on the small antigen-binding variable regions of heavy-chain-only antibodies (VHH). Nanobodies® have a number of potential advantages over traditional antibodies, including their small size, enhanced tissue penetration, resistance to temperature changes, ease of manufacturing, and their ability to be designed into multivalent therapeutic molecules with bespoke target combinations.
The terms Nanobody® and Nanobodies® are trademarks of Ablynx, a Sanofi company.
About SonelokimabSonelokimab (M1095) is an investigational ~40 kDa humanized Nanobody® consisting of three VHHs covalently linked by flexible glycine-serine spacers. With two domains, sonelokimab selectively binds with high affinity to IL-17A and IL-17F, thereby inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F dimers. A third central domain binds to human albumin, facilitating further enrichment of sonelokimab at sites of inflammatory edema.
Sonelokimab is being assessed in two lead indications, hidradenitis suppurativa (HS) and psoriatic arthritis (PsA), and the Company is pursuing other indications in dermatology and rheumatology, including adolescent HS, palmoplantar pustulosis (PPP) and axial spondyloarthritis (axSpA).
For adults with HS, sonelokimab is being assessed in two identical Phase 3 trials, the VELA-1 and VELA-2 trials, using the higher clinical response level of HS Clinical Response (HiSCR) 75 as the primary endpoint, which defines a response as an at least 75% reduction in abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count. In September 2025, the primary endpoint data from the VELA-1 and VELA-2 clinical trials were announced. In the combined VELA program, patients treated with SLK experienced a clinically meaningful and statistically significant improvement across all primary and key secondary endpoints using both pre-specified strategies (p
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