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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 announced that the FDA will review its New Drug Application (NDA) for arimoclomol on August 2, 2024. Arimoclomol is an oral treatment for Niemann-Pick disease type C (NPC), a rare genetic disorder. This review will be conducted by the Genetic Metabolic Diseases Advisory Committee (GeMDAC), newly formed by the FDA. The FDA plans to release background materials two business days before the meeting, and a Prescription Drug User Fee Act (PDUFA) action date has been set for September 21, 2024. Zevra's CEO, Neil F. McFarlane, emphasized the importance of this review for the NPC community, which lacks an approved therapy.
Zevra Therapeutics announced the appointment of Rahsaan W. Thompson as Chief Legal Officer, Secretary, and Compliance Officer, and Alison Peters as Chief People Officer. Both bring extensive experience to their roles, vital for Zevra's growth in rare disease therapeutics. Mr. Thompson, with over 25 years in the biotech sector, has vast expertise in corporate governance, SEC compliance, and litigation. Ms. Peters, with more than 20 years in human capital management, excels in talent acquisition and corporate culture. Additionally, both executives received inducement equity awards, with Mr. Thompson granted 200,000 restricted stock units and Ms. Peters 150,000, vesting over three years. These appointments are aligned with Zevra's strategic goals to enhance its commercial capabilities and advance its rare disease portfolio.
Zevra Therapeutics has partnered with Orsini Specialty Pharmacy as the new pharmacy provider for OLPRUVA® (sodium phenylbutyrate), used to manage certain urea cycle disorders (UCDs) in both adults and children. UCDs are rare genetic conditions that hinder the body's ability to eliminate excess ammonia, which can lead to severe neurological damage if untreated. OLPRUVA® helps mitigate this risk by acting as a nitrogen scavenger to remove excess ammonia. This collaboration aims to enhance access to OLPRUVA® for patients struggling with UCDs.
Zevra Therapeutics announced positive final results from its Phase 2 clinical trial of KP1077 for idiopathic hypersomnia (IH) at SLEEP 2024. KP1077 showed significant improvements in daytime sleepiness, sleep inertia, and brain fog with good tolerance across various doses. The European Commission granted Orphan Drug Designation for KP1077 for IH treatment. Key findings include substantial decreases in ESS, IHSS, SIVAS, and BFS scores, indicating notable clinical benefits. Additionally, pharmacokinetic data suggested effective morning and nighttime dosing without significant adverse events. These findings support initiating a Phase 3 trial.
Zevra Therapeutics, Inc. (ZVRA) will participate in several investor events in May 2024, with Neil F. McFarlane, the President and CEO, presenting at conferences in New York and Boston. The company aims to engage with investors and provide updates on their rare disease therapeutics.
Zevra Therapeutics, Inc. reported its Q1 2024 financial results, including $3.4 million in revenue, increasing R&D and SG&A expenses, a net loss of ($16.6) million, and a cash balance of $52.7 million. The Company refinanced its debt, securing up to $100 million in committed capital.
Zevra Therapeutics, Inc. (ZVRA) will report Q1 2024 results on May 8, 2024. The rare disease therapeutics company will hold a conference call to discuss corporate and financial performance.
Zevra Therapeutics, Inc., a rare disease therapeutics company, releases a letter to stockholders by Neil F. McFarlane, President and CEO, highlighting key accomplishments and outlook for 2024. The letter emphasizes a patient-centric approach, team building, and progress in advancing rare disease therapies. The company's financial strength, governance enhancements, and future prospects are also discussed.
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