MoonLake Immunotherapeutics' Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by MoonLake Immunotherapeutics (MLTX).
Over the past two years, MoonLake Immunotherapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Sonelokimab. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Sonelokimab FDA Regulatory Timeline and Events
Sonelokimab is a drug developed by MoonLake Immunotherapeutics for the following indication: Moderate-to-severe hidradenitis suppurativa.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Sonelokimab
- Announced Date:
- March 28, 2026
- Indication:
- Moderate-to-severe hidradenitis suppurativa
Announcement
MoonLake Immunotherapeutics announces long-term Week 40 results of the Phase 3 VELA-1 and VELA-2 clinical trials of its registrational global program in patients with moderate-to-severe HS and confirms the presentation of the data at the 2026 American Academy of Dermatology (AAD) Annual Meeting later today.
AI Summary
MoonLake Immunotherapeutics announced long-term Week 40 results from its Phase 3 VELA-1 and VELA-2 trials in moderate-to-severe hidradenitis suppurativa (HS) and confirmed the data will be presented today at the 2026 American Academy of Dermatology Annual Meeting. At Week 40, 62% of patients on sonelokimab (SLK) reached a HiSCR75 response, a level the company says sets a new standard for long-term lesion control. For context, approved IL‑17A inhibitors and IL‑17A/F inhibitors have reported HiSCR75 rates near 40% and 60%, respectively, at one year in pooled pivotal-trial analyses.
The safety profile of SLK in the VELA trials remained consistent with no new safety signals. Prof. Alexa Kimball will present the findings (S034 Late-Breaking Research: Session 2) on March 28, 2026, 4:00–4:12 pm ET (2:00–2:12 pm MT). Key upcoming milestones include Q2 2026 52-week VELA data, mid-2026 IZAR-1 PsA readout, and H2 2026 plans for a BLA submission in HS and the IZAR-2 PsA readout.
Read Announcement- Drug:
- Sonelokimab
- Announced Date:
- February 21, 2026
- Indication:
- Moderate-to-severe hidradenitis suppurativa
Announcement
MoonLake Immunotherapeutics announces topline results from the S-OLARIS Phase 2 trial of SLK in patients with radiographic and non-radiographic axSpA and announces its financial results for the fourth quarter and year ended December 31, 2025.
AI Summary
MoonLake Immunotherapeutics announced topline positive results from the S-OLARIS Phase 2 trial of SLK (sonelokimab) in patients with radiographic and non-radiographic axial spondyloarthritis (axSpA). Company statements said the data further strengthen SLK’s potential across a range of inflammatory diseases and mark the fifth indication with positive Phase 2 or Phase 3 data for the IL‑17A and F Nanobody®.
Sonelokimab is being evaluated in several programs, including VELA‑TEEN Phase 3 for adolescent hidradenitis suppurativa (HS), and ongoing Phase 2 S‑OLARIS and P‑OLARIS trials for axSpA and psoriatic arthritis (PsA). MoonLake noted these trials combine traditional clinical outcomes with cellular imaging to better characterize drug effects.
MoonLake also announced its financial results for the fourth quarter and year ended December 31, 2025, and said the positive S‑OLARIS topline supports continued development and upcoming clinical milestones across its pipeline.
Read Announcement- Drug:
- Sonelokimab
- Announced Date:
- February 2, 2026
- Indication:
- Moderate-to-severe hidradenitis suppurativa
Announcement
MoonLake Immunotherapeutics announces that the FDA has granted Fast Track designation for sonelokimab for the treatment of moderate‑to‑severe PPP. MoonLake had submitted a request for Fast Track designation on December 1, 2025.
AI Summary
MoonLake Immunotherapeutics announced that the FDA has granted Fast Track designation for sonelokimab to treat moderate-to-severe palmoplantar pustulosis (PPP). MoonLake submitted its Fast Track request on December 1, 2025. The designation recognizes the serious burden of PPP and the absence of approved treatments, and is meant to help streamline the drug’s development.
Fast Track status provides benefits such as more frequent FDA meetings and written feedback on trial design and biomarker use, potential eligibility for Accelerated Approval and Priority Review if criteria are met, and Rolling Review so completed BLA sections can be submitted as they are ready. These tools are intended to speed collection of the data needed to support approval and could shorten timelines for patients with this unmet medical need. MoonLake will continue clinical development of sonelokimab across dermatology and rheumatology indications.Read Announcement
- Drug:
- Sonelokimab
- Announced Date:
- January 8, 2026
- Indication:
- Moderate-to-severe hidradenitis suppurativa
Announcement
MoonLake Immunotherapeutics 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.
AI Summary
MoonLake Immunotherapeutics requested a Type B meeting with the U.S. Food and Drug Administration to discuss the clinical evidence strategy for submitting a Biologic License Application (BLA) for sonelokimab (SLK) in hidradenitis suppurativa (HS). The FDA provided positive written feedback on that strategy.
The FDA indicated MoonLake may establish substantial evidence of effectiveness (SEE) for SLK in HS without running new HS trials, using data from the existing MIRA, VELA-1 and VELA-2 studies. The agency specifically advised including the MIRA results in the BLA and stated VELA-2 should be submitted to inform SLK’s safety profile, even if it is not relied on to establish SEE.
The FDA also said mechanistic evidence combined with a single clinical trial cannot serve as confirmatory evidence to establish SEE. Based on the meeting records, MoonLake will proceed with BLA preparations, aiming for submission in H2 2026, and will hold an Investor Day on February 23, 2026 to discuss the feedback and new data.
Read Announcement- Drug:
- Sonelokimab
- Announced Date:
- October 1, 2025
- Indication:
- Moderate-to-severe hidradenitis suppurativa
Announcement
MoonLake Immunotherapeutics nnounced disastrous VELA-2 trial results for sonelokimab, its highly anticipated treatment for patients with skin disease (hidradenitis suppurative or "HS").
AI Summary
MoonLake Immunotherapeutics shares plunged 90% after the company announced that its VELA-2 trial for sonelokimab failed to meet its week-16 primary endpoint in patients with hidradenitis suppurativa. The highly anticipated treatment showed only a 9% improvement over placebo, far below the expected 20%.
The trial was affected by more intercurrent events in the placebo arm than predicted, which prevented statistical significance in the composite HiSCR75 measure. Analysts called the outcome “arguably the worst‐case scenario” for a late-stage study.
National firm Hagens Berman has launched an investigation into whether MoonLake misled investors about the trial design, planning for intercurrent events, and the likelihood of achieving key efficacy targets. Before the results, MoonLake had expressed strong confidence that sonelokimab could become the “gold standard.”
Investors who suffered substantial losses and whistleblowers with relevant information are encouraged to contact Hagens Berman to participate in the ongoing probe.
Read Announcement- Drug:
- Sonelokimab
- Announced Date:
- February 26, 2025
- Indication:
- Moderate-to-severe hidradenitis suppurativa
Announcement
MoonLake Immunotherapeutics Provides clinical updates
AI Summary
MoonLake Immunotherapeutics has provided clinical updates on its progress with the Nanobody® sonelokimab. The company advanced its Phase 3 VELA program, which targets moderate-to-severe hidradenitis suppurativa (HS) in adult patients, and it has launched the Phase 3 IZAR program for patients with active psoriatic arthritis (PsA). In addition, new trials are set to begin in early 2025, including the Phase 3 VELA-TEEN trial for adolescents with HS, a Phase 2 LEDA trial for palmoplantar pustulosis (PPP), and a Phase 2 S-OLARIS trial for axial spondyloarthritis (axSpA). MoonLake’s CEO highlighted the company’s commitment to data-rich developments in 2025, with pivotal HS data expected by mid‐2025 and plans to update the market during their Capital Markets Update in Q2 of 2025.
Read Announcement- Drug:
- Sonelokimab
- Announced Date:
- June 10, 2024
- Indication:
- Moderate-to-severe hidradenitis suppurativa
Announcement
MoonLake Immunotherapeutics announced the successful outcome of its end-of-Phase 2 interactions with the U.S. Food and Drug Administration (FDA), as well as positive feedback from its interactions with the E.U. European Medicines Agency (EMA), with both regulatory bodies unanimously supporting MoonLake's proposed approach for advancing its Phase 3 program of the Nanobody® sonelokimab in psoriatic arthritis (PsA).
AI Summary
MoonLake Immunotherapeutics announced that both the U.S. FDA and the E.U. EMA have given positive regulatory feedback on its Phase 3 program for its Nanobody® sonelokimab in psoriatic arthritis (PsA). The agencies unanimously supported MoonLake’s proposed approach, paving the way for the upcoming IZAR program. This program is designed to include two global, randomized, double-blind, placebo-controlled trials that will examine the safety and efficacy of sonelokimab over one year, including assessments of radiographic progression in biologic naive patients and comparison with an active reference for TNF-inhibitor experienced patients. The program plans to test both 60mg and 120mg doses of sonelokimab in a total population of approximately 1,500 patients, with key trial endpoints set to be evaluated at week 16 and primary endpoint readout expected at the end of 2026.
Read Announcement- Drug:
- Sonelokimab
- Announced Date:
- May 16, 2024
- Indication:
- Moderate-to-severe hidradenitis suppurativa
Announcement
MoonLake Immunotherapeutics announced that the first patients have been screened at a U.S. trial site in its global Phase 3 clinical program, VELA, evaluating sonelokimab, an investigational Nanobody® designed to treat inflammatory disease, in patients with moderate-to-severe hidradenitis suppurativa (HS).
AI Summary
MoonLake Immunotherapeutics has announced an important step in its global Phase 3 clinical program, VELA. The company revealed that the first patients have now been screened at a U.S. trial site. This marks the beginning of an important evaluation of sonelokimab, an investigational Nanobody® designed to treat inflammatory diseases.
Sonelokimab is being tested specifically in patients suffering from moderate-to-severe hidradenitis suppurativa (HS), a chronic skin condition marked by painful, inflamed lesions. This trial aims to assess whether sonelokimab can reduce inflammation and improve symptoms for those affected. The news highlights the ongoing effort to find effective treatments for HS and supports the progression of new therapies from early research toward potential approval and use in clinical practice.
Read Announcement
MoonLake Immunotherapeutics FDA Events - Frequently Asked Questions
As of now, MoonLake Immunotherapeutics (MLTX) has not received any FDA approvals for its therapy in the last two years.
In the past two years, MoonLake Immunotherapeutics (MLTX) has reported FDA regulatory activity for Sonelokimab.
The most recent FDA-related event for MoonLake Immunotherapeutics occurred on March 28, 2026, involving Sonelokimab. The update was categorized as "Results," with the company reporting: "MoonLake Immunotherapeutics announces long-term Week 40 results of the Phase 3 VELA-1 and VELA-2 clinical trials of its registrational global program in patients with moderate-to-severe HS and confirms the presentation of the data at the 2026 American Academy of Dermatology (AAD) Annual Meeting later today."
Currently, MoonLake Immunotherapeutics has one therapy (Sonelokimab) targeting the following condition: Moderate-to-severe hidradenitis suppurativa.
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FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
FDA progress for NASDAQ:MLTX last updated on 3/30/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
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