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.