Vanda Pharmaceuticals Submits Imsidolimab BLA To FDA, Stock Gains In Pre-Market

Vanda Pharmaceuticals

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(RTTNews) - Vanda Pharmaceuticals Inc. (VNDA), Monday announced that the company has submitted a Biologics License Application or BLA to the U.S. Food and Drug Administration for imsidolimab to treat generalized pustular psoriasis, a rare, chronic autoinflammatory skin disorder.

The application is backed by positive results from the global Phase 3 GEMINI-1 and GEMINI-2 studies, which demonstrated that a single intravenous dose of imsidolimab led to rapid disease clearance.

Moreover, the biopharmaceutical company has requested a priority review for the BLA. If granted, the priority review would establish a six-month review cycle, with a potential FDA approval of imsidolimab as early as mid-2026.

CEO Mihael Polymeropoulos commented, "We look forward to potential FDA approval and leveraging our commercial infrastructure to address this debilitating condition."

In the pre-market hours, VNDA is trading at $6.61, up 6.10 percent on the Nasdaq.