Investing.com -- Vanda Pharmaceuticals Inc (NASDAQ:VNDA) stock jumped 5.1% Monday after the company announced it submitted a Biologics License Application (BLA) to the FDA for imsidolimab, a treatment for generalized pustular psoriasis (GPP).
The company’s application for the IL-36 receptor antagonist is supported by positive results from its global Phase 3 GEMINI-1 and GEMINI-2 studies. According to Vanda, a single intravenous dose of imsidolimab led to rapid disease clearance, with efficacy maintained throughout an approximately 2-year maintenance study period with monthly doses.
GPP is a rare, chronic, life-threatening autoinflammatory skin disorder characterized by sudden flares of widespread pustules, erythema, and systemic symptoms. The condition represents a significant unmet medical need, with prevalence estimates ranging from approximately 2 to 124 cases per million worldwide.
In the 45-patient GEMINI-1 Phase 3 trial, 53% of patients receiving either dose of imsidolimab achieved clear or almost clear skin at Week 4, compared to 13% on placebo. Responders who continued in the GEMINI-2 maintenance study maintained clear or almost clear skin with no flares when receiving monthly imsidolimab doses.
Vanda has requested priority review for the BLA, which would establish a six-month review cycle if granted. This could potentially lead to FDA approval as early as mid-2026.
The company noted that imsidolimab builds on its growing expertise in rare orphan disorders and anti-inflammatory portfolio, which includes Ponvory, currently approved for multiple sclerosis and in development for psoriasis and ulcerative colitis.
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