MoonLake Immunotherapeutics

MLTX

Market cap $1.24B

MoonLake Immunotherapeutics is downgraded from Strong Buy to Buy following a mixed phase 3 outcome for sonelokimab in hidradenitis suppurativa [HS]. Despite VELA-2's primary endpoint miss, the FDA's positive Type B meeting allows MLTX to file a BLA for HS using existing VELA-1, VELA-2, and MIRA data. MLTX advances sonelokimab in multiple inflammatory indications, with strong phase 2 axSpA results [81% ASAS40 at Week 12] and upcoming phase 3 PsA data in 2026.

MoonLake Immunotherapeutics (MLTX) Analyst/Investor Day Transcript

Axial Spondyloarthritis is a chronic, immune-mediated inflammatory disease mainly affecting the spine and sacroiliac joints, often causing chronic back pain, stiffness, and potential spinal fusion.

Brings 20+ years of clinical development experience in autoimmune and inflammatory diseases, including OX40/OX40L program leadership Will build and lead Imagene's clinical organization and drive completion of the Phase 2b ADAPTIVE trial in atopic dermatitis Will expand Phase 2b trial footprint with planned international sites including in the UK and Europe SAN DIEGO, Feb. 10, 2026 (GLOBE NEWSWIRE) -- ImageneBio, Inc. (Nasdaq: IMA, “Imagene,” or the “Company”), today announced the appointment of Dr. Ben Porter-Brown, a seasoned autoimmune and inflammatory drug developer with experience in the OX40 receptor-ligand (OX40-OX40L) inhibition field, as its Chief Medical Officer. He will be focused on driving execution of the Phase 2b ADAPTIVE trial in atopic dermatitis (AD) and building Imagene's clinical organization.

In a stock market currently obsessed with interest rate cuts and the artificial intelligence (AI) boom, it is easy to overlook the biotechnology sector. However, for investors willing to look beyond the Magnificent Seven, clinical-stage biotech remains one of the few places to find massive, event-driven returns that are largely independent of the broader economy.

ZUG, Switzerland, February 2, 2026 – MoonLake Immunotherapeutics (NASDAQ:MLTX) (“MoonLake” or the “Company”), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, today announces that the FDA has granted Fast Track designation for sonelokimab for the treatment of moderate‑to‑severe PPP. MoonLake had submitted a request for Fast Track designation on December 1, 2025. This follows the positive outcome of the Company's recent FDA interactions in which it confirmed its clinical evidence strategy for the planned submission of a BLA for SLK in HS in H2 2026. The Company also confirmed details for its upcoming Investor Day, which will take place on February 23, 2026, featuring in‑depth clinical and regulatory updates across multiple indications, including newly generated data from the S‑OLARIS program for SLK in axSpA.

MoonLake regains momentum after the FDA Type B meeting allows BLA submission for sonelokimab in HS without additional trials. MLTX is de-risked, with a BLA submission targeted for 2H26, removing a major regulatory overhang and accelerating the timeline. Sonelokimab's existing Phase 2 MIRA and Phase 3 VELA data now form the basis for regulatory submission, supporting efficacy and safety.

MoonLake Immunotherapeutics (NASDAQ: MLTX) on Thursday received U.S. Food and Drug Administration (FDA) feedback regarding the clinical evidence strategy for Sonelokimab (SLK) in Hidradenitis Suppurativa (HS), based on the Type B meeting requested by MoonLake.

Shares of MoonLake Immunotherapeutics catapulted Thursday after potentially aligning with the FDA on a path forward for its skin disease drug.

NEW YORK, Dec. 15, 2025 (GLOBE NEWSWIRE) -- Levi & Korsinsky, LLP notifies investors in MoonLake Immunotherapeutics ("MoonLake" or the "Company") (NASDAQ: MLTX) of a class action securities lawsuit.