Vanda Pharmaceuticals Inc. (VNDA) on Wednesday said the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for imsidolimab for the treatment of Generalized Pustular Psoriasis (GPP), a rare autoinflammatory skin disorder.
A decision from the regulator is expected on December 12, 2026.
In the pivotal efficacy studies GEMINI-1 and GEMINI-2, a single intravenous dose of imsidolimab produced rapid disease clearance, with 53% of patients achieving clear or almost clear skin by Week 4, compared with 13% on placebo. Efficacy was sustained over approximately 2 years of monthly maintenance dosing, with no flares reported in the treatment arm. Imsidolimab demonstrated a favorable safety profile and a low incidence of anti-drug antibodies.
Vanda Pharmaceuticals shares closed at $8.17 on Tuesday, up 0.25%.
For comments and feedback contact: editorial@rttnews.com
April 10, 2026 16:21 ET Inflation data from the U.S. was the main data event this week as the conflict in the Middle East continue. The minutes of the latest Fed policy session and the survey data on the services sector also made headlines. In Europe, manufacturing orders data from Germany was in focus. Price data from China drew attention in Asia.