BioTech Breakout: MoonLake Up 30% On FDA Wins

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.

MarketBeat • Feb 3, 2026

MoonLake Announces FDA Fast Track Designation for Sonelokimab Palmoplantar Pustulosis (PPP) and Provides Details on Upcoming Investor Day

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.

GlobeNewsWire • Feb 2, 2026

MoonLake: Positive FDA Meeting Spurs Momentum Ahead Of BLA Submission

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.

Seeking Alpha • Jan 9, 2026

MoonLake Catapults On FDA Deal For Its Down-And-Out Skin Disease Drug

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

Investors Business Daily • Jan 8, 2026

MoonLake Says FDA May Allow Skin Drug Filing Without New Trials, Stock Soars

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.

Benzinga • Jan 8, 2026

Contact Levi & Korsinsky by December 15, 2025 Deadline to Join Class Action Against MoonLake Immunotherapeutics(MLTX)

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.

GlobeNewsWire • Dec 15, 2025

MLTX DEADLINE ALERT: Hagens Berman Alerts MoonLake (MLTX) Investors to Today's Lead Plaintiff Deadline in Securities Class Action

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.

PRNewsWire • Dec 15, 2025

MLTX Investors Have Opportunity to Lead MoonLake Immunotherapeutics Securities Fraud Lawsuit with the Schall Law Firm

LOS ANGELES--(BUSINESS WIRE)---- $MLTX--MLTX Investors Have Opportunity to Lead MoonLake Immunotherapeutics Securities Fraud Lawsuit with the Schall Law Firm.

Business Wire • Dec 15, 2025

Portnoy Law Firm Announces Class Action on Behalf of Moonlake Immunotherapeutics, Inc. Investors

LOS ANGELES, Dec. 15, 2025 (GLOBE NEWSWIRE) -- The Portnoy Law Firm advises MoonLake Immunotherapeutics, Inc., (“MoonLake” or the "Company") (NASDAQ: MLTX) investors of a class action on behalf of investors that bought securities between March 10, 2024, and September 29, 2025, inclusive (the “Class Period”). MoonLake investors have until December 15, 2025, to file a lead plaintiff motion.

GlobeNewsWire • Dec 15, 2025

Shareholders that lost money on MoonLake Immunotherapeutics(MLTX) Urged to Join Class Action - Contact The Gross Law Firm to Learn More

NEW YORK , Dec. 15, 2025 /PRNewswire/ -- The Gross Law Firm issues the following notice to shareholders of MoonLake Immunotherapeutics (NASDAQ: MLTX).  Shareholders who purchased shares of MLTX during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointment.

PRNewsWire • Dec 15, 2025