MoonLake schedules FDA Type B meeting for sonelokimab HS BLA package

MoonLake confirmed a Type B meeting with the FDA on December 15, 2025 to discuss whether the current clinical evidence package from the VELA-1 and VELA-2 trials is adequate to support a BLA submission for sonelokimab in hidradenitis suppurativa. The meeting outcome will determine the regulatory path and timing for the planned Q3/Q4 2026 BLA filing.

Key facts

Filed: Nov 5, 2025, 12:00 PM
Event: Advisory committee scheduled
Direction: Neutral
Company: MLTXMoonLake
Asset: sonelokimab
Source: SEC 8-K
Confidence: Sourced
Calendar: Advisory committee · Dec 15, 2025 · Outcome not recorded

Source excerpt

EX-99.1 2 moonlake-pressreleasexq320.htm EX-99.1 Document MoonLake Immunotherapeutics Reports Third Quarter 2025 Financial Results and Announces New Data from Clinical Trials of its Nanobody® Sonelokimab • Ended the third quarter with $380.5 million in cash, cash equivalents and short-term marketable debt securities which, together with funds from a previously announced debt-facility, are expected to provide runway into the second half of 2027 • Reported results of its Phase 2 LEDA clinical trial in Palmoplantar Pustulosis (PPP) where sonelokimab (SLK) demonstrated clinically meaningful and statistically significant benefit • Reported an interim analysis of the long-term data from the VELA-1 and VELA-2 clinical trials in adults with Hidradenitis Suppurativa (HS), as well as an interim analysis of its VELA-TEEN clinical trial in adolescent HS, demonstrating the potential and competitive benefit of SLK in these patient populations • Confirmed a Type B meeting with the U.S. Food and Drug Administration (FDA), scheduled to be held on December 15, 2025, to discuss adequacy of the current clinical evidence package of SLK in HS to support a Biologics License Application (BLA) • Other clinical trials of SLK progressing well and expected to support a catalyst-rich roadmap over the next 12 months, including data releases from the Phase 2 S-OLARIS trial in Axial Spondyloarthritis (axSpA) and the Phase 3 IZAR trials in Psoriatic Arthritis (PsA) ZUG, Switzerland, November 5, 2025 – Mo

SEC 8-K