MoonLake Immunotherapeutics MLTX
MoonLake Immunotherapeutics (Nasdaq: MLTX) is a dermatology drug developer. Its lead program, Sonelokimab (SLK), is in Phase 3 for Hidradenitis suppurativa (HS). Its next catalyst on record is SLK - HS: FDA acceptance decision on BLA submission (November 2026).
Upcoming catalysts
- November 2026SLK - HS — FDA acceptance decision on BLA submission
We expect to be notified by the FDA whether the BLA submission is accepted for review within approximately 60 days of submission
- November 2026SLK - PPP (NOVA) — Phase 3 enrollment commencement
We expect to commence enrollment for the Phase 3 NOVA trial (M1095-PPP-301) in November 2026
- December 2026SLK - HS — Planned review timeline from FDA
to receive the planned review timeline within approximately 74 days of submission
Next further out: SLK - HS adolescent (VELA-TEEN) — Trial completion (Q4 2026). 5 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| Sonelokimab (SLK) | Hidradenitis suppurativa (HS) - adult | antibody | Phase 3 |
| Sonelokimab (SLK) | Hidradenitis suppurativa (HS) - adolescent (VELA-TEEN) | antibody | Phase 3 |
| Sonelokimab (SLK) | Psoriatic arthritis (PsA) - IZAR-1 | antibody | Phase 3 |
| Sonelokimab (SLK) | Psoriatic arthritis (PsA) - IZAR-2 | antibody | Phase 3 |
| Sonelokimab (SLK) | Palmoplantar pustulosis (PPP) - NOVA | antibody | Phase 3 |
| Sonelokimab (SLK) | Axial spondyloarthritis (axSpA) - P-OLARIS | 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 - met Sonelokimab met all clinical endpoints at Week 16 in the Phase 3 IZAR-1 trial in biologic-naïve psoriatic arthritis patients, with 42.1% achieving ACR50 response.
In August 2026, the Company announced positive results from an analysis of the Week 16 primary endpoint in the Phase 3 IZAR-1 trial in psoriatic arthritis (PsA), which met all clinical endpoints at Week 16 for 60 mg SLK.
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 dermatology 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.