MoonLake Immunotherapeutics MLTX
MoonLake Immunotherapeutics (Nasdaq: MLTX) is an immunology/inflammation drug developer. Its lead program, sonelokimab (SLK, M1095), is in Phase 3 for moderate-to-severe hidradenitis suppurativa (HS). Its next catalyst on record is SLK VELA-TEEN: Final topline results (H2 2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: SLK VELA-TEEN — Final topline results (H2 2026). 4 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| SLK VELA-1/VELA-2/VELA-OLE | hidradenitis suppurativa (adult) | antibody | Phase 3 |
| SLK VELA-TEEN | adolescent HS | antibody | Phase 3 |
| SLK IZAR-1 | psoriatic arthritis | antibody | Phase 3 |
| SLK IZAR-2 | psoriatic arthritis | antibody | Phase 3 |
| SLK NOVA | palmoplantar pustulosis | antibody | Phase 3 |
| SLK P-OLARIS | axial/non-radiographic spondyloarthritis | antibody | Phase 2 |
Recent results and decisions
- Sep 30, 2026submitted MoonLake Immunotherapeutics submitted a BLA to the FDA seeking approval of sonelokimab for the treatment of moderate-to-severe hidradenitis suppurativa in adults and pediatric patients 12 years of age and older.
MoonLake Immunotherapeutics (the 'Company') submitted a Biologics License Application ('BLA') to the U.S. Food and Drug Administration ('FDA'), seeking approval of its tri-specific nanobody sonelokimab for the treatment of moderate-to-severe hidradenitis suppurativa in adults and pediatric patients
Filing - Aug 10, 2026met Phase 3 IZAR-1 met primary endpoint: ACR50 42.1% at Week 16 with 60 mg plus induction; ACR20 66.5%, MDA 41.2%, PASI90 61%.
The primary endpoint of ACR50 was met with a high response of 42.1% for sonelokimab’s 60 mg with induction, and significant responses were observed across key secondary endpoints, including ACR20 (66.5%), MDA (41.2%) and PASI90 (61%)
Filing - Feb 22, 2026positive Phase 2 S-OLARIS: 80+% of patients achieved ASAS40 by Week 12, with similar gains on ASDAS-CRP and SPARCC MRI.
In the Phase 2 S-OLARIS clinical trial in axial spondyloarthritis (axSpA), sonelokimab (SLK) demonstrated clinically meaningful benefit with 80+% of patients achieving ASAS40 by Week 12
Filing
2 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 immunology/inflammation companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.