• MoonLake Immunotherapeutics cleared its final pre-BLA meeting with FDA for sonelokimab in hidradenitis suppurativa, removing remaining filing gaps and setting up a planned BLA submission for end-September 2026.
• FDA alignment supports a label strategy that includes both adult and adolescent patients, with MoonLake planning to seek Priority Review tied to inclusion of adolescent trial data.
• Company framed MIRA study outcome as supportive of efficacy for filing, with a safety package anchored by Phase 3 VELA trials, without flagging new clinical concerns.
• Additional trial results have not yet been presented, with Phase 3 VELA 52-week data due in Q2 2026 and Phase 3 VELA-TEEN primary readout expected mid-2026.
• U.S. launch timing remains contingent on approval, with first commercial rollout expected in second half of 2027.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Moonlake Immunotherapeutics published the original content used to generate this news brief via EDGAR, the Electronic Data Gathering, Analysis, and Retrieval system operated by the U.S. Securities and Exchange Commission (Ref. ID: 0001821586-26-000005), on May 11, 2026, and is solely responsible for the information contained therein.