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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.
Access timely press releases and curated news covering clinical trial progress, FDA communications, and partnership announcements. Our repository ensures efficient tracking of Zevra's patient-centric developments in complex therapeutic areas, including late-stage trial outcomes and commercialization strategies.
Key updates on: clinical program advancements, regulatory submissions, research partnerships, and therapy commercialization efforts. Bookmark this page for streamlined access to Zevra's evolving role in addressing unmet rare disease needs through science-driven solutions.
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.
Zevra Therapeutics (NasdaqGS: ZVRA) announced the appointment of Wendy L. Dixon, Ph.D., to its Board of Directors, effective immediately after the 2023 Annual Meeting on April 25, 2023. This follows the resignation of Dr. Travis Mickle, who co-founded Zevra. Dr. Dixon, with over 40 years of biopharma experience, previously held senior roles at Bristol Myers Squibb and Merck. Chairman Matthew Plooster emphasized her extensive industry experience as Zevra focuses on rare diseases. Dr. Dixon expressed excitement about contributing to Zevra's mission to provide solutions for patients with rare diseases.
Zevra Therapeutics (ZVRA) has announced its collaboration as a founding member of the Sleep Data Initiative, aimed at supporting research for sleep disorders. This initiative, led by RARE-X and the Sleep Consortium, emphasizes the importance of patient-owned data in advancing treatment development. Additionally, Zevra received U.S. Patent No. 11,505,537 for serdexmethylphenidate (SDX), the active ingredient in its lead product candidate, KP1077, targeting idiopathic hypersomnia (IH). The patent secures its intellectual property rights, extending until at least 2037. Zevra's commitment to addressing rare sleep disorders is underscored by its Phase 2 clinical trial for KP1077.
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