MoonLake soars as FDA clears path for skin disease drug filing

MoonLake Immunotherapeutics

08/01/2026 13:38

** Shares of Swiss biotech MoonLake Immunotherapeutics MLTX.O rise 37.6% to $15.53 premarket

** Co says it has received positive feedback from the U.S. FDA that will allow the co to move forward with its BLA  application for sonelokimab without more trials

** Co's sonelokimab targets hidradenitis suppurativa, a painful chronic skin condition causing lesions and scarring - MLTX

** The drug showed better outcomes vs placebo in over 1,000 patients, says co

** Co plans BLA submission in the second half of 2026

** A BLA or Biologics License Application is a formal request to the FDA seeking approval to market a biologic drug in the U.S. after demonstrating safety and effectiveness

** As of last close, stock down ~14% over the past year

 (Reporting by Sahil Pandey in Bengaluru)

 ((Sahil.Pandey@thomsonreuters.com))