Vanda Pharma Stock Rises Pre-Market After FDA Accepts Imsidolimab Filing For Rare Skin Disorder

• Vanda noted that in the Gemini-1 and Gemini-2 studies evaluating the efficacy of Imsidolimab, more than half of the patients achieved clear or almost clear skin by the fourth week, compared to 13% on placebo.
• The company said that efficacy was maintained throughout an approximately 2-year maintenance period with monthly doses, and no flares occurred in the active treatment arm.
• Vanda added that GPP is a rare disorder with prevalence estimates varying widely by region, ranging from approximately 2 to 124 cases per million worldwide.

Vanda Pharmaceuticals Inc. (VNDA) on Wednesday announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application for Imsidolimab for the treatment of Generalized Pustular Psoriasis (GPP).

The company noted that if the FDA approves its application, Imsidolimab could address a significant unmet medical need in this rare and life-threatening disorder.

Vanda shares were up nearly 5% in Wednesday’s pre-market trade. Retail sentiment on Stocktwits around the company trended in the ‘extremely bullish’ territory at the time of writing.

Vanda Says Over Half Of Patients Achieved Clear Or Almost Clear Skin

Vanda noted that in the Gemini-1 and Gemini-2 studies evaluating the efficacy of Imsidolimab, more than half of the patients achieved clear or almost clear skin by the fourth week, compared to 13% on placebo.

The company said that efficacy was maintained throughout an approximately 2-year maintenance period with monthly doses, and no flares occurred in the active treatment arm.

Vanda added that GPP is a rare disorder with prevalence estimates varying widely by region, ranging from approximately 2 to 124 cases per million worldwide.

“Imsidolimab builds on our growing expertise in rare orphan disorders and our anti-inflammatory portfolio. Imsidolimab represents a precision medicine approach targeting a disorder with a known genetic cause using a fully humanized monoclonal antibody against the IL-36 receptor,” said Vanda CEO Mihael H. Polymeropoulos.

What Does Vanda Do?

Vanda Pharmaceuticals is a Washington-based biopharmaceutical company focused on the development and commercialization of therapies that cater to highly unmet medical needs.

Imsidolimab is a fully humanized IgG4 monoclonal antibody that inhibits IL-36 receptor signaling. The company expects regulatory and patent exclusivity for the treatment to extend into the late 2030s.

VNDA stock is down 7% year-to-date, but up 88% over the past 12 months.

Also See: RXRX Stock Soars Pre-Market On Q4 Beat, Recursion CEO Says Company Has ‘Reached An Inflection Point’

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