Sonelokimab (SLK) — Topline data
H2 2026
We expect to announce final topline results from the VELA-TEEN clinical trial in the second half of 2026.Source filing
MLTX biotech catalysts & pipeline
MOONLAKE IMMUNOTHERAPEUTICS · Data as of 2026-09-08
Upcoming catalysts
Sonelokimab (SLK) — Topline data
Sep 2026–Apr 2027
In addition, we expect results of the P-OLARIS trial (M1095-snSpA-202) to become available at the end of 2026 or early 2027.Source filing
Sonelokimab (SLK) — NDA/BLA submission
Sep 2026
Submission of the Biologics License Application (BLA) for SLK in HS, including data from adolescent patients, is expected at the end of September 2026, and will follow previous agency guidance on the label strategySource filing
Sonelokimab (SLK) — PDUFA
Nov 2026
End Nov. 2026: Expected to receive Prescription Drug User Fee Act (PDUFA) date allocation and decision on Priority ReviewSource filing
Sonelokimab (SLK) — Topline data
H1 2027
The IZAR-1 trial remains blinded and will continue until Week 52 with MoonLake expecting the full readout in H1 2027 whereas the IZAR-2 trial (a trial in TNF-refractory patients) is expected to complete enrollment in Q3 2026Source filing