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Zevra Therapeutics Inc (ZVRA) is a biopharmaceutical innovator focused on rare diseases, combining advanced data analytics with targeted clinical development. This page provides investors and healthcare stakeholders with essential updates on Zevra's therapeutic advancements, regulatory milestones, and strategic collaborations.
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Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) announced the submission of an IND application to the FDA to initiate a Phase 1 clinical trial for KP1077 in narcolepsy. This expands the ongoing Phase 2 trial for idiopathic hypersomnia (IH), with data potentially leading to pivotal Phase 3 studies for both conditions. The FDA confirmed no additional non-clinical studies are needed for KP1077, which is based on the established compound serdexmethylphenidate. Zevra is focused on advancing therapies for rare diseases and previously received various designations for its product Arimoclomol to treat Niemann-Pick disease type C.