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Vanda Pharmaceuticals Secures EU Orphan Status for Psoriasis Drug

European regulators have granted orphan drug designation to imsidolimab, a specialized treatment for generalized pustular psoriasis. This recommendation from the European Medicines Agency marks a breakthrough for Vanda Pharmaceuticals, positioning the candidate as the first therapy for the rare skin condition to receive such status within the European Union.

Vanda Pharmaceuticals Secures EU Orphan Status for Psoriasis Drug

The Committee for Orphan Medicinal Products issued the positive opinion on Thursday, confirming that the drug addresses a significant unmet medical need. Chief Executive Officer Mihael Polymeropoulos noted the decision serves as a formal recognition of the condition’s rarity in the EU, while validating the clinical data collected throughout the imsidolimab program.

Following the announcement, Vanda shares rose 1.8% to $5.55 in after-hours trading. Despite this uptick, the stock has faced a challenging year, with a prior decline of 38% and a 6.8% drop during Thursday’s regular session.

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