MoonLake Immunotherapeutics (MLTX)

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 (NASDAQ: MLTX) used its Investor Day presentation to outline updates across its clinical portfolio for sonelokimab (SLK), a tri-specific nanobody designed to inhibit IL-17A and IL-17F while also binding human albumin. Company leadership emphasized a development strategy spanning multiple large inflammatory indications in dermatology and rheumatology, and reiterated expectations for a U.S. biologics license

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.

In the Phase 2 S-OLARIS clinical trial in axial spondyloarthritis (axSpA), sonelokimab (SLK) demonstrated clinically meaningful benefit with 80% of patients achieving ASAS40 by Week 12 Consistently, other clinical and imaging scores also showed improvements of 80% by week 12 for patients treated with SLK, including ASDAS-CRP and SPARCC MRI axSpA is a disease driven by inflammation leading to irreversible ossification (via osteoblast activity) and ultimately to irreversible restriction of mobility - objective PET/MRI imaging data further showed a significant reduction in inflammation and osteoblast activity deep in affected joints, already by week 12, suggesting potential for disease modification in axSpA for SLK As a biomarker-controlled trial, S-OLARIS data showed SLK reduced the levels of key inflammatory mediators in axSpA, in peripheral blood and biopsy samples from patients - the safety profile of SLK was similar to other trials and no new signals were detected MoonLake ended the fourth quarter with $394 million in cash, cash equivalents and short-term marketable debt securities which, together with funds from its latest equity raise (gross proceeds of $75 million), are expected to provide a cash runway into the second half of 2027 The Company also announced the amendment of its debt facility with Hercules Capital, with a concurrent drawdown of $25 million, and up to $400 million in non-dilutive funds remaining available to support future funding needs An Investor Day webcast has been confirmed for February 23, 2026, 8.

Principal Financial Group Inc. purchased a new stake in MoonLake Immunotherapeutics (NASDAQ: MLTX) in the third quarter, according to the company in its most recent Form 13F filing with the Securities and Exchange Commission (SEC). The institutional investor purchased 70,943 shares of the company's stock, valued at approximately $509,000. Principal Financial Group Inc.

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.

Nuvation Bio (NYSE: NUVB - Get Free Report) and MoonLake Immunotherapeutics (NASDAQ: MLTX - Get Free Report) are both medical companies, but which is the better investment? We will compare the two companies based on the strength of their earnings, valuation, institutional ownership, risk, profitability, analyst recommendations and dividends. Risk and Volatility Nuvation Bio has a beta

Shares of MoonLake Immunotherapeutics (NASDAQ: MLTX - Get Free Report) shot up 9.6% during trading on Friday. The stock traded as high as $16.29 and last traded at $15.7210. 1,836,121 shares traded hands during trading, a decline of 68% from the average session volume of 5,667,113 shares. The stock had previously closed at $14.34. MoonLake

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.

MoonLake requested a Type B meeting with the U. S. Food and Drug Administration (FDA) to obtain regulatory clarity and discuss the clinical evidence strategy for submission of a Biologic License Application (BLA) for Sonelokimab (SLK) in Hidradenitis Suppurativa (HS) FDA feedback confirms that the Company may establish substantial evidence of effectiveness (SEE), without additional clinical trials in HS, with a BLA consisting of data from its existing VELA-1, VELA-2 and MIRA trials The FDA specifically advised the Company to include the results of the MIRA trial in the submission and to submit the results of the VELA-2 trial for the marketing application to inform the safety profile of SLK, regardless of decisions on its utility in establishing SEE Based on the positive final official records of this Type B meeting MoonLake will continue its plans for BLA submission for SLK in HS in H2 2026 An Investor Day to further discuss FDA feedback and value opportunities for SLK in HS and to share new clinical data, in HS and other indications, will be held on February 23rd, 2026 ZUG, Switzerland, January 8, 2026 - MoonLake Immunotherapeutics (NASDAQ: MLTX) ("MoonLake" or the "Company"), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, today provided an update following the positive feedback received from the U.

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.

SAN FRANCISCO , Dec. 15, 2025 /PRNewswire/ -- Global plaintiffs' rights firm Hagens Berman reminds investors that the Lead Plaintiff Deadline in the securities class action lawsuit against MoonLake Immunotherapeutics (NASDAQ: MLTX) is rapidly approaching: December 15, 2025 . The lawsuit alleges that MoonLake and certain executives made materially false and misleading statements regarding the clinical prospects of the company's lead and sole drug candidate, sonelokimab (SLK), causing the stock to crash nearly 90% on the revelation of disappointing Phase 3 trial results.