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Zevra Therapeutics, Inc. - ZVRA STOCK NEWS

Welcome to our dedicated page for Zevra Therapeutics news (Ticker: ZVRA), a resource for investors and traders seeking the latest updates and insights on Zevra Therapeutics stock.

Zevra Therapeutics, Inc. (symbol: ZVRA) is a pioneering rare disease company dedicated to developing transformational therapies for conditions with limited or no treatment options. By combining science, data, and patient needs, Zevra aims to deliver life-changing solutions to individuals living with rare diseases. Their mission is to address these unmet medical needs through unique, data-driven development and commercialization strategies.

Zevra Therapeutics utilizes its proprietary Ligand Activated Therapy (LAT) approach to create improved prodrug versions of FDA-approved medications. These prodrugs target high-need areas such as pain management, ADHD, and other central nervous system diseases. Through this innovative technology, Zevra is overcoming complex drug development challenges and making new therapies accessible to the rare disease community.

Recent achievements include significant advancements in their pipeline projects, particularly in pain and ADHD treatment. The company is also known for its strategic partnerships, which enhance its research and development capabilities and accelerate the commercialization of its therapies. Financially, Zevra has a solid foundation, allowing it to focus on its core mission of addressing rare diseases and improving patients' lives.

For up-to-date information, news, and latest developments, Zevra encourages stakeholders to stay connected through their official contact points:

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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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Zevra Therapeutics presents new data on the long-term safety and efficacy of Arimoclomol as a treatment for Niemann-Pick Disease Type C at the SIMD 45th Annual Meeting.
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Zevra Therapeutics, Inc. secures a new $100M credit facility led by Perceptive Advisors and Healthcare Royalty to support its rare disease therapeutics development. The facility includes an initial draw of $60M, with additional tranches available upon meeting certain conditions. Zevra retires existing debt of $43.1M, with net proceeds of $14.0M. The five-year facility bears interest at 12.33% per annum and allows in-kind interest payments. This move aims to strengthen Zevra's financial position and advance its strategic goals for 2024 and beyond.
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FAQ

What does Zevra Therapeutics, Inc. specialize in?

Zevra Therapeutics focuses on developing transformational therapies for rare diseases using their proprietary LAT technology.

What is the company's mission?

The mission of Zevra Therapeutics is to bring life-changing therapeutics to people living with rare diseases.

What is the Ligand Activated Therapy (LAT) approach?

The LAT approach is a proprietary method used by Zevra to create improved prodrug versions of FDA-approved medications.

Which areas of medical needs does Zevra's technology target?

Zevra's technology targets high-need areas such as pain management, ADHD, and other central nervous system diseases.

Who are the primary contacts for investor relations?

Primary contacts include Nichol Ochsner, David Schull, and Ignacio Guerrero-Ros, Ph.D.

How does Zevra ensure the financial stability of their projects?

Zevra has a solid financial foundation, allowing them to focus on their core mission of addressing rare diseases.

What recent achievements has Zevra made?

Zevra has made significant advancements in their pipeline projects, especially in pain and ADHD treatment.

What kind of partnerships does Zevra engage in?

Zevra engages in strategic partnerships to enhance research, development, and accelerate commercialization efforts.

How can stakeholders stay updated with Zevra's latest news?

Stakeholders can stay updated by connecting with official contact points including Nichol Ochsner and representatives from Russo Partners.

What is the significance of Zevra’s prodrug development?

Zevra's prodrug development is significant as it creates improved versions of existing FDA-approved drugs to better meet patient needs.

Zevra Therapeutics, Inc.

Nasdaq:ZVRA

ZVRA Rankings

ZVRA Stock Data

253.21M
41.85M
8.39%
33.84%
6.61%
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