Zevra Therapeutics
- Country
- 🇺🇸United States
- Ownership
- Public
- Established
- 2006-01-01
- Employees
- 69
- Market Cap
- $379.3M
- Website
- http://zevra.com
- Introduction
Zevra Therapeutics, Inc. is a commercial-stage rare disease company that combines science, data and patient needs to create therapies for diseases with limited or no treatment options. The firm focuses on the treatment of rare neurological and sleep conditions such as certain Urea Cycle Disorders, Niemann Pick Disease Type C and Idiopathic Hypersomnia. The company receives royalties for AZSTARYS from its commercial partner Corium. The company was founded by Christal M. M. Mickle and Travis C. Mickle on October 30, 2006 and is headquartered in Celebration, FL.
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U.S. Drug Prices Double as Pharmaceutical Industry Shifts Focus to Rare Diseases
The median annual list price for newly launched pharmaceuticals in the U.S. has more than doubled to $370,000 in 2024 compared to $180,000 in 2021, according to a Reuters analysis.
XOMA Royalty Expands Portfolio to Over 120 Assets, Reports Financial Results for 2024
• XOMA Royalty doubled its portfolio to over 120 royalty assets through five strategic transactions in 2024, strengthening its position as a biotech royalty aggregator. • The company completed two whole company acquisitions and celebrated FDA approvals for Day One's OJEMDA™ (tovorafenib) and Zevra's MIPLYFFA™ (arimoclomol), generating significant milestone payments. • Despite reporting a net loss of $13.8 million for 2024, XOMA Royalty received $46.3 million in cash receipts and maintains over $100 million in cash, positioning it for sustainable cashflow from royalties.
Hypersomnia Pipeline Shows Promise with 10+ Emerging Therapies in Development
DelveInsight's latest report reveals 8+ companies developing 10+ therapies for hypersomnia, with Avadel's Lumryz, Zevra's KP1077, and Alkermes' ALKS 2680 among the key candidates advancing through clinical trials.
FDA Priority Review Vouchers Face Transparency Challenges Amid Rising Prices
Priority Review Vouchers (PRVs) have surged in value to $150-158 million in recent months, up from the typical $100 million, following Congress's failure to reauthorize the rare pediatric disease program.
Congress's Failure to Renew Priority Review Voucher Program Threatens Rare Disease Drug Development
The FDA's rare pediatric disease Priority Review Voucher program expired in December 2023, despite unanimous congressional support for renewal, leaving biotech companies unable to receive new vouchers worth approximately $150 million.
FDA Approves Five Groundbreaking Treatments for Ultra-Rare Diseases in Recent Months
• The FDA has approved novel therapies for Duchenne Muscular Dystrophy, including ITF Therapeutics' Duvyzat (givinostat), which targets histone deacetylases to potentially slow muscle deterioration. • Breakthrough gene therapy Lenmeldy received approval for Metachromatic Leukodystrophy, offering the first targeted treatment option with significant survival benefits for pediatric patients. • Multiple rare diseases saw first-ever treatments, including Xolremdi for WHIM syndrome, dual approvals for Niemann-Pick Disease Type C, and Ctexli for Cerebrotendinous Xanthomatosis.
Zevra Therapeutics Secures $150M Deal for Rare Pediatric Disease Priority Review Voucher
• Zevra Therapeutics has entered into a definitive agreement to sell its Rare Pediatric Disease Priority Review Voucher for $150 million, with the transaction expected to close within 30-45 days. • The PRV was awarded following FDA approval of MIPLYFFA, a treatment for neurological manifestations of Niemann-Pick disease type C in patients aged 2 and older. • The deal is subject to standard closing conditions, including Hart-Scott Rodino Antitrust Improvements Act waiting period expiration, with Cantor Fitzgerald serving as financial advisor.
FDA Expands Rare Disease Research Support with $27 Million in Grants and New Innovation Hub
The FDA has awarded $17.2 million in clinical trial grants for seven rare disease treatments, including therapies for Cushing's syndrome, blood disorders, cancer, and an inherited eye disease.
Dual Blood Pressure Medication Strategy Halves Arterial Events in vEDS Patients
A Phase 3 ARCADE trial demonstrates that combining irbesartan with celiprolol reduces severe arterial events by 50% in vascular Ehlers-Danlos syndrome patients over two years.