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 reports developments as a commercial-stage biopharmaceutical company focused on therapies for rare diseases. Recurring updates center on MIPLYFFA (arimoclomol), its U.S.-approved treatment for Niemann-Pick disease type C, including commercialization, patient access, regulatory activity and diagnostic-support initiatives tied to NPC.
Zevra news also covers financial results, pipeline programs in rare diseases such as vascular Ehlers-Danlos syndrome, and corporate actions that shape its portfolio. Recent company updates include the completed sale of the serdexmethylphenidate, or SDX, portfolio, including AZSTARYS and KP1077, as well as governance and executive-compensation announcements under Nasdaq rules.
Zevra Therapeutics (NASDAQ: ZVRA) has filed its preliminary proxy statement for the 2025 Annual Meeting, nominating two directors for re-election: Wendy L. Dixon and Tamara A. Favorito. The company faces a proxy contest from stockholder Daniel J. Mangless, who proposes two alternative candidates.
The current board comprises eight directors, with seven being independent and seven joining since 2023. The company reports significant progress, including:
- Launch of first two products
- Record net product revenue in Q4 2024
- Cash runway extending into 2029
- Recent sale of Priority Review Voucher for $150 million
The board recommends stockholders reject Mangless's nominees, including former CEO Travis C. Mickle, arguing that changes could disrupt the company's strategic execution. Stockholders are advised to wait for the definitive proxy materials with the WHITE proxy card before taking any action.
Zevra Therapeutics (ZVRA) reported FY 2024 financial results with net revenue of $23.6 million, including $12.0 million in Q4 2024. The company posted a net loss of $105.5 million ($2.28 per share) for 2024, compared to $46.0 million loss in 2023.
Key highlights include the successful commercial launch of MIPLYFFA following FDA approval in September 2024, with 109 prescription enrollment forms received by year-end. The company entered into an agreement to sell its Rare Pediatric Disease Priority Review Voucher (PRV) for $150 million.
Cash position stood at $75.5 million as of December 31, 2024. With current operating forecast and excluding PRV sale proceeds, Zevra projects cash runway into 2029. The Phase 3 DiSCOVER trial for celiprolol enrolled 27 total patients, and the company plans to file for EU marketing authorization for MIPLYFFA in H2 2025.
Zevra Therapeutics (ZVRA) has launched a new disease state awareness campaign called 'Learn NPC, Read Between the Signs' on Rare Disease Day, February 28, 2025. The initiative aims to improve early recognition and diagnosis of Niemann-Pick disease type C (NPC), an ultra-rare, progressive, and neurodegenerative lysosomal storage disorder.
The campaign, launched through www.LearnNPC.com, provides educational resources and testing information for healthcare professionals to better identify NPC, which is often challenging to diagnose due to its varying age of onset and diverse symptom presentation.
The National Niemann-Pick Disease Foundation (NNPDF) has expressed support for the campaign, highlighting its importance in increasing disease awareness among healthcare professionals. The initiative includes resources such as disease summaries, diagnostic challenges, symptom overviews, and testing options for suspected NPC cases.
Zevra Therapeutics (ZVRA) has entered into an agreement to sell its Rare Pediatric Disease Priority Review Voucher (PRV) for $150 million in gross proceeds. The transaction is expected to close within 30-45 days, subject to customary conditions.
The PRV was awarded to Zevra in September 2024 following FDA approval of MIPLYFFA™ (arimoclomol), a treatment for neurological manifestations of Niemann-Pick disease type C in patients 2 years and older. The non-dilutive capital will support the commercial launches of MIPLYFFA™ and OLPRUVA®, along with advancing the company's rare disease pipeline.
Zevra Therapeutics (ZVRA), a commercial-stage company specializing in rare disease therapies, has scheduled its fourth quarter and full year 2024 financial results announcement for Tuesday, March 11, 2025. The company will release its financial results after market close, followed by a conference call and audio webcast at 4:30 p.m. ET.
Investors can access the webcast through Zevra's investor relations website, with dial-in options available for both U.S. (800-245-3047) and international (+1-203-518-9765) participants using Conference ID: ZVRAQ424. A replay of the webcast will be available for 90 days following the presentation.
Zevra Therapeutics (NASDAQ: ZVRA), a commercial-stage rare disease therapy company, has announced its participation in two major investor conferences in March 2025. The company's executive leadership team will present at the TD Cowen 45th Annual Health Care Conference on March 5, 2025, at 10:30 a.m. ET, and the 37th Annual ROTH Conference on March 17, 2025, at 1:00 p.m. PT.
Management will be available for one-on-one meetings with registered attendees at both conferences. Interested parties can access live webcasts of the presentations through the 'Events & Presentations' section on Zevra's Investor Relations website at investors.zevra.com.
Zevra Therapeutics (ZVRA) announced its participation in the 21st Annual WORLDSymposium™, where it will receive a 2025 New Treatment Award for MIPLYFFA™. Eight abstracts related to MIPLYFFA (arimoclomol) have been accepted for poster presentation, with one selected for oral presentation by Dr. Eugen Mengel.
MIPLYFFA is approved for treating neurological manifestations of Niemann-Pick disease type C (NPC) in patients 2 years and older, used in combination with miglustat. The featured presentation will discuss efficacy results from a 12-month double-blind randomized trial using the re-scored 4-domain NPC Clinical Severity Score.
The poster presentations will cover various aspects including gene expression, real-world treatment data, regulatory journey, safety profiles, and long-term efficacy. E-posters will be available to registered attendees from February 4, 2025, through the WORLDSymposium mobile app, with on-demand access extending to March 14, 2025. The symposium takes place February 3-7, 2025, in San Diego, CA.
Zevra Therapeutics (ZVRA), a commercial-stage rare disease therapeutics company, has announced its participation in two major investor conferences in February 2025. The company's executive leadership team will present at the Guggenheim Securities SMID Cap Biotechnology Conference on February 5 at 2:30 p.m. ET, and the Oppenheimer & Co. 35th Annual Healthcare Life Sciences Conference on February 12 at 3:20 p.m. ET.
Management will be available for one-on-one meetings with registered attendees at both conferences. Interested parties can access live webcasts of the presentations through the 'Events & Presentations' section on Zevra's Investor Relations website at investors.zevra.com.
Zevra Therapeutics (ZVRA) announced its upcoming addition to the Nasdaq Biotechnology Index (NBI) effective December 23, 2024, as part of the annual index reconstitution. The inclusion reflects the company's meeting of eligibility requirements, including minimum market capitalization, average daily trading volume, and biotechnology industry classification.
The NBI tracks the performance of biotechnology and pharmaceutical securities listed on Nasdaq under a modified capitalization-weighted methodology. CEO Neil F. McFarlane highlighted this as a transformational year for Zevra, noting that the index inclusion will raise the company's profile among biotech funds and portfolio managers.
Zevra Therapeutics (ZVRA) announced organizational changes as part of its transformation into a rare disease therapeutics company. The company is consolidating its development and scientific functions under CMO Adrian Quartel, who will oversee clinical development, quality assurance, and regulatory affairs.
Key changes include the departure of Chief Development Officer Christal Mickle and Chief Scientific Officer Sven Guenther in December 2024. The company is eliminating positions in CMC and Clinical Development, discontinuing in-house drug discovery activities, and closing laboratories in Iowa and Virginia. Future early R&D will be outsourced.
These changes align with Zevra's 2025 Strategic Plan focusing on late-stage clinical and commercial opportunities, built on four pillars: Commercial Excellence, Pipeline and Innovation, Talent and Culture, and Corporate Foundation.