GlobeNewswire·Aug 10, 2026, 7:00 AM ET

MoonLake Announces Positive Topline Results from the Phase 3 IZAR-1 Trial of Sonelokimab in Psoriatic Arthritis Demonstrating Significant Improvements Across all Clinical Endpoints, and Reports Second Quarter 2026 Financial Results

MLTX

MoonLake Immunotherapeutics announced that the Phase 3 IZAR-1 trial in biologic-naïve patients with psoriatic arthritis met all clinical endpoints at Week 16 for the 60 mg sonelokimab dose with induction.
The primary endpoint of ACR50 was achieved with a 42.1% response rate, while key secondary endpoints showed 66.5% for ACR20, 41.2% for MDA, 61% for PASI90, and significant improvements in HAQ-DI and SF-36 PCS scores.
Blinded safety analysis revealed a profile consistent with previous studies with no new safety signals identified.
The IZAR-1 trial remains blinded until Week 52 completion, with a full readout expected in H1 2027, while the IZAR-2 trial in TNF-refractory patients is expected to complete enrollment in Q3 2026.
MoonLake held $537.0 million in cash, cash equivalents, & short-term marketable debt securities as of June 30, 2026, with a runway extending to mid-2028 & up to $400 million in non-dilutive funds available via its debt facility with Hercules Capital.
Research & development expenses for the second quarter of 2026 were $50.2 million, down from $54.5 million in the prior quarter, while general & administrative expenses decreased to $11.4 million from $15.5 million.
Upcoming milestones include the expected submission of a Biologics License Application for hidradenitis suppurativa in September 2026, a PDUFA date allocation in November 2026, & the commencement of enrollment for the palmoplantar pustulosis trial in H2 2026.
The company highlighted sonelokimab's potential to become a leading treatment for psoriatic arthritis, supporting its entry into this multi-billion dollar indication following its lead focus on hidradenitis suppurativa.