FDA Events for MoonLake Immunotherapeutics (MLTX)
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:
- 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 February 26, 2025, involving Sonelokimab. The update was categorized as "Clinical Update," with the company reporting: "MoonLake Immunotherapeutics Provides clinical updates"
Currently, MoonLake Immunotherapeutics has one therapy (Sonelokimab) targeting the following condition: Moderate-to-severe hidradenitis suppurativa.
More FDA Event Resources from MarketBeat
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
This page (NASDAQ:MLTX) was last updated on 7/11/2025 by MarketBeat.com Staff
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