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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 (NASDAQ: ZVRA) announced the final results of its 2025 Annual Meeting of Stockholders, where shareholders overwhelmingly re-elected Wendy L. Dixon, Ph.D. and Tamara A. Favorito as Class I Directors to serve until 2028. The incumbent directors received approximately 74% of the votes, defeating potential opposition nominees Travis C. Mickle and Arthur C. Regan, who would have received only 26.45% and 23.97% respectively. The opposition nominations were ultimately disregarded due to failure to meet SEC and bylaw requirements. Stockholders also approved Ernst & Young LLP as the company's independent auditors for FY2025.
Zevra Therapeutics (ZVRA) reported strong Q1 2025 financial results with net revenue of $20.4 million, primarily driven by $17.1 million from MIPLYFFA sales. The company completed the sale of its Pediatric Rare Disease Priority Review Voucher for $150 million, significantly strengthening its balance sheet to $217 million in cash and equivalents.
Commercial progress includes 13 new MIPLYFFA prescriptions in Q1 (total 122) with 38% market access coverage, and 5 new OLPRUVA patients (total 28) with 78% market access. The company reported a reduced net loss of $3.1 million ($0.06 per share) compared to $16.6 million in Q1 2024. Operating expenses were $22.8 million, with R&D expenses decreasing by $9.0 million while SG&A increased by $9.6 million due to commercial activities.
The company remains on track for MIPLYFFA's European MAA filing in H2 2025 and has enrolled 32 patients in the Phase 3 DiSCOVER trial for celiprolol.Zevra Therapeutics (NASDAQ: ZVRA), a commercial-stage company focused on rare disease therapies, has scheduled its Q1 2025 financial results announcement for Tuesday, May 13, 2025. The company will release its corporate and 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 website investor relations section. For telephone participation, U.S. callers can dial (800) 245-3047, while international participants should use +1 (203) 518-9765, with Conference ID: ZVRAQ125. A replay will be available on the company's website for 90 days following the presentation.
Zevra Therapeutics (ZVRA), a commercial-stage rare disease therapeutics company, has announced its participation in the upcoming Citizens Life Science Conference in New York. The company's executive leadership team will engage in a fireside chat on Wednesday, May 7, 2025, at 11:30 a.m. ET. Management will also be available for one-on-one meetings with registered conference attendees. Investors can access the live webcast through the "Events & Presentations" section on Zevra's investor relations website at investors.zevra.com.
Zevra Therapeutics (ZVRA) has filed its definitive proxy statement for the 2025 Annual Meeting scheduled for May 29, urging stockholders to vote for two incumbent directors - Wendy L. Dixon and Tamara A. Favorito. The company highlights a 54.8% total stockholder return under its refreshed board and management team.
The Board strongly opposes attempts by Daniel J. Mangless, a 2.8% stockholder, to replace two directors. Mangless, who already has three nominees on the board from 2023, seeks to add two more nominees - Travis C. Mickle and Arthur C. Regan. The company argues this would give Mangless majority board control without presenting any clear strategic plans.
Under current leadership, Zevra has launched two rare disease therapies: MIPLYFFA® for Niemann-Pick disease type C, which earned a Priority Review Voucher sold for $150 million, and OLPRUVA® for urea cycle disorders. The company is executing a five-year strategic plan focused on commercial excellence, pipeline innovation, talent development, and corporate foundation strengthening.
Zevra Therapeutics (ZVRA) has published new research in Molecular Genetics and Metabolism detailing the mechanism of action of MIPLYFFA® in treating Niemann-Pick disease type C (NPC). The study reveals that arimoclomol enters cells and increases the movement of translation factors EB and E3 (TFEB & TFE3) from cytosol to nucleus.
This process triggers the upregulation of CLEAR genes, including NPC1, which is important for lysosomal function. The increased CLEAR gene expression leads to higher NPC1 protein levels in lysosomes, resulting in improved cholesterol trafficking. Animal studies demonstrated that this improved trafficking correlates with better neurological behaviors, specifically in rearing and gait.
Zevra Therapeutics (ZVRA) has completed the sale of its Rare Pediatric Disease Priority Review Voucher (PRV) for $150 million in gross proceeds. The PRV was granted by the FDA in September 2024 following the approval of MIPLYFFA™ (arimoclomol), the first U.S. approved treatment for Niemann-Pick type C, an ultra-rare neurodegenerative disease.
The company reported unaudited cash, cash equivalents and investments of $68.7 million as of March 31, 2025. After the PRV sale's net proceeds of $148.3 million, the total cash position would be $217.0 million. The non-dilutive capital will support strategic priorities including the commercial launches of MIPLYFFA and OLPRUVA®, ongoing Phase 3 trial for celiprolol, and future strategic investments.
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.
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