(RTTNews) - 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%.
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