ZEVRA THERAPEUTICS, INC. (ZVRA) Zevra Therapeutics, Inc., founded in 2006 and based in Celebration, Florida, is a biopharmaceutical company dedicated to discovering and developing innovative treatments for rare diseases. The company employs its proprietary Ligand Activated Therapy (LAT) technology to create novel prodrug versions of existing FDA-approved medications or to enable new applications for other compounds, primarily addressing serious medical conditions within the United States. Zevra's development pipeline is strategically concentrated on high-unmet-need therapeutic areas, including attention deficit hyperactivity disorder (ADHD), stimulant use disorder, and various rare central nervous system (CNS) conditions, such as idiopathic hypersomnia (IH). Their lead product candidate, KP1077, which is a prodrug of d-methylphenidate (known as serdexmethylphenidate), is currently in Phase II clinical trials for the treatment of both IH and narcolepsy. Another key prodrug candidate, KP879, is also advancing through Phase II studies for stimulant use disorder. In addition to its pipeline, Zevra has successfully secured FDA approval for two products: AZSTARYS, a once-daily treatment for ADHD in patients aged six years and older, and APADAZ, an immediate-release combination product containing benzhydrocodone (a prodrug of hydrocodone) and acetaminophen. The company's product portfolio also includes arimoclomol, and it holds collaboration and licensing agreements with KVK-Tech, Inc. and Commave Therapeutics SA. Formerly known as KemPharm, Inc., the company officially rebranded to Zevra Therapeutics, Inc. in February 2023.
Sector: Pharmaceutical Preparations
Industry: Biotechnology
Zevra Therapeutics, Inc. NASDAQ:ZVRA Healthcare · Biotechnology
Mkt Cap $610.47M
Vol 0
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Press Release
Zevra Therapeutics Announces Details for Q3 2026 Financial Results Call
Zevra Therapeutics will report Q3 2026 corporate and financial results on Tuesday, November 3, 2026, after market close.
A conference call and audio webcast will follow at 4:30 p.m. ET, with a replay available for 90 days.
This is a scheduling notice only — no results or guidance were included.
• 12d ago AI analysis › Press Release
Zevra Therapeutics to Present at Upcoming Investor Conferences
Zevra Therapeutics' executive leadership team will present at three investor conferences in New York in September 2026.
The schedule includes fireside chats at the Cantor Global Healthcare Conference on September 9, the Morgan Stanley 24th Annual Global Healthcare Conference on September 14, and the H.C. Wainwright 28th Annual Global Investment Conference on September 15, with management also available for one-on-one meetings.
Live webcast links will be posted in the Events & Presentations section of Zevra's investor relations website. The release contains no new financial, clinical, or regulatory disclosures.
• 1mo ago AI analysis › Press Release
Zevra Therapeutics to Present New Long-Term Real-World Data on MIPLYFFA® in Niemann-Pick Disease Type C (NPC) at the 2026 SSIEM Annual Symposium
Zevra Therapeutics announced the presentation of two posters featuring long-term real-world data on MIPLYFFA (arimoclomol) for Niemann-Pick disease type C at the SSIEM Annual Symposium.
Data from the U.S. Expanded Access Program demonstrated durable disease stabilization through four years, with minimal changes in disease severity scores aligning with the pivotal trial's 65% reduction in disease progression.
Additionally, findings from a German compassionate use program showed up to eight years of treatment exposure with no discontinuations due to treatment-related adverse events, supporting the therapy's long-term safety profile.
• 2mo ago AI analysis › Press Release
Zevra Therapeutics Announces Inducement Grants under Nasdaq Listing Rule 5635(c)(4)
Zevra Therapeutics granted inducement options to purchase an aggregate of 92,200 shares of common stock to four new employees pursuant to its 2023 Employment Inducement Award Plan.
The awards were approved by the Compensation Committee as a material inducement to employment and vest over four years, with 25% vesting on the first anniversary and the remainder in equal annual installments.
The grants are consistent with Nasdaq Listing Rule 5635(c)(4) and support the company's hiring efforts.
• 2mo ago AI analysis › Press Release ● Major
Zevra Reports Second Quarter 2026 Financial Results and Corporate Update
Zevra reported Q2 2026 net revenue of $39.7 million, up 53% year-over-year, driven primarily by $30.2 million in revenue from its lead asset MIPLYFFA for Niemann-Pick disease type C.
On a non-GAAP basis, adjusted net income was $15.2 million, or $0.25 per diluted share, compared to an adjusted net loss of $2.4 million in the prior year period.
The company ended the quarter with a strong cash position of $260.2 million and stated that its resources are sufficient to execute strategic priorities without relying on capital markets.
• 2mo ago AI analysis › Press Release
Zevra Therapeutics to Present at the Canaccord Genuity Annual Growth Conference
Zevra Therapeutics announced that members of its executive leadership team will present at the Canaccord Genuity 46th Annual Growth Conference in Boston on August 11, 2026.
Management will be available for one-on-one meetings with registered conference attendees during the event.
A live webcast of the presentation will be accessible through the Events & Presentations page on the company's investor relations website.
• 2mo ago AI analysis › Press Release
Zevra Therapeutics Announces Publication of Four-Year Real-World Data from U.S. Early Access Program Evaluating MIPLYFFA® (arimoclomol) in Niemann-Pick Disease Type C (NPC)
Zevra Therapeutics announced the publication of four-year real-world data in Molecular Genetics and Metabolism demonstrating that MIPLYFFA maintained stable disease severity scores in patients with Niemann-Pick disease type C (NPC).
The US Early Access Program study evaluated 109 participants across 14 sites, with mean arimoclomol exposure of 820 days, showing safety observations consistent with the established profile of the therapy.
This data provides the first published real-world evidence for adults with NPC, a historically understudied population, and supports the long-term use of the company's FDA-approved treatment.
• 2mo ago AI analysis › Press Release ● Major ⚠ 2
Zevra Therapeutics Provides Update on Regulatory Submission for Arimoclomol for the Treatment of Niemann-Pick Disease Type C (NPC) in the European Union
The CHMP has adopted a negative opinion regarding the Marketing Authorization Application for arimoclomol for the treatment of Niemann-Pick disease type C in the European Union.
Zevra plans to request a re-examination of the opinion and continues to support patient access through its global Expanded Access Program.
While arimoclomol is currently marketed in the U.S., the negative opinion represents a significant setback for European expansion.
• 3mo ago AI analysis › Press Release
Zevra Therapeutics Announces Details for Q2 2026 Financial Results Call
Zevra Therapeutics will report its second quarter 2026 financial results on August 5, 2026, after the market closes.
The company plans to host a conference call and audio webcast at 4:30 p.m. ET that day to discuss corporate and financial performance.
Investors can access the live broadcast and replay via the Events & Presentations page on the Zevra investor relations website.
• 3mo ago AI analysis › Press Release
Zevra Therapeutics Announces Publication of Positive MIPLYFFA® Data from Pediatric Substudy in Infants with Niemann-Pick Disease Type C (NPC)
Zevra Therapeutics announced the publication of positive data from a Phase 2/3 open-label pediatric substudy evaluating MIPLYFFA in infants with Niemann-Pick disease type C.
The study, which included five children aged 12 to <24 months, found that arimoclomol was generally well tolerated with no new safety signals and pharmacokinetic results consistent with older pediatric populations.
These results provide preliminary evidence supporting the initiation of treatment in this younger age group, where the disease is often most devastating.
• 4mo ago AI analysis › Press Release
Zevra’s Chief Medical Officer to Step Down for Personal Reasons as Part of Planned Transition
Zevra Therapeutics announced that Chief Medical Officer Adrian Quartel will step down effective July 3, 2026, citing personal reasons.
Dr. Quartel will remain in a consulting capacity through December 31, 2026, to ensure a seamless transition while the company searches for a successor.
CEO Neil McFarlane emphasized that the company remains on track with key regulatory milestones, including the EMA review of arimoclomol and the Phase 3 trial of celiprolol.
• 4mo ago AI analysis › Press Release
Zevra Therapeutics Announces Orange Book Listing of U.S. Patent Strengthening Exclusivity for MIPLYFFA
Zevra Therapeutics submitted U.S. Patent No. 11,707,456 for its lead drug MIPLYFFA to the FDA for listing in the Orange Book.
The patent expires on November 19, 2041, extending the period of regulatory exclusivity and delaying potential generic entry for the treatment of Niemann-Pick disease type C.
The company also noted that a separate patent term extension for an earlier patent (expiring 2029) remains pending with the USPTO.
• 4mo ago AI analysis › Press Release
Zevra Therapeutics Announces Inducement Grants under Nasdaq Listing Rule 5635(c)(4)
Zevra Therapeutics granted options to purchase 33,000 shares of common stock to four new employees.
The awards were issued under Nasdaq Listing Rule 5635(c)(4) as inducements material to the employees' entry into employment.
Each award vests over four years, with 25% vesting on the first anniversary and the remainder in equal annual installments.
• 5mo ago AI analysis › Press Release
Zevra Therapeutics to Present at the H.C. Wainwright BioConnect Investor Conference
globenewswire.com • 5mo ago Press Release ● Major
Zevra Reports First Quarter 2026 Financial Results and Corporate Update
globenewswire.com • 5mo ago Press Release
Zevra Therapeutics Announces Details for Q1 2026 Financial Results Call
Zevra Therapeutics will release its first quarter 2026 financial results after the market close on Wednesday, May 6, 2026.
Management is scheduled to host a conference call and audio webcast at 4:30 p.m. ET on the same day to discuss the quarterly performance.
Zevra is a commercial-stage biopharmaceutical company focused on rare diseases, with a marketed lead product for Niemann-Pick disease type C.
• 6mo ago AI analysis › 6 law-firm class-action alerts