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# Moonlake Immunotherapeutics Plans BLA Submission
- URL: https://www.fdaweb.com/moonlake-immunotherapeutics-plans-bla-submission/
- Published: 2026-01-08T12:00:00.000Z
- Updated: 2026-09-14T15:30:11.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160458

Moonlake Immunotherapeutics says it plans to submit a BLA to FDA in the second half of 2026 for sonelokimab to treat hidradenitis suppurativa. A company [statement](https://ir.moonlaketx.com/news-releases/news-release-details/moonlake-immunotherapeutics-announces-positive-outcome-type-b?ref=fdaweb.com) says the decision to move forward followed a successful Type B meeting with FDA that confirmed that the company may establish substantial evidence of effectiveness, without additional clinical trials, using data from the existing VELA-1, VELA-2, and MIRA trials.

Sonelokimab is described as an investigational -40 kDa humanized Nanobody consisting of three VHHs covalently linked by flexible glycine-serine spacers. Nanobodies are said to represent a new generation of antibody-derived targeted therapies that consist of one or more domains based on the small antigen-binding variable regions of heavy-chain-only antibodies (VHH).