ZEVRA THERAPEUTICS, INC.
No SEC Form 4 filings for $ZVRA in the last 30 days.
Zevra Therapeutics (NASDAQ:ZVRA) reported Q2 updates on MIPLYFFA, including high refill, compliance and persistence, and payer coverage of 69% of covered lives. Net reimbursements were $9 million. In the EU, Zevra will re-examine arimoclomol after a CHMP negative opinion, with an expected Q4 decision. Cash was $260.2 million.
ZEVRA THERAPEUTICS, INC. (ZVRA) filed an SEC Form 8-K — Results of Operations and Financial Condition. EX-99.1 2 zvra-20260805xex991earnings.htm EX-99.1 Document Exhibit 99.1 Zevra Reports Second Quarter 2026 Financial Results and Corporate Update $39.7 million net revenue for Q2 2026, driven by $30.2 million in revenue from MIPLYFFA 53% increase in total net revenue over Q2 2025
Zevra Therapeutics said the EMA CHMP issued a negative opinion on its marketing authorization application for arimoclomol to treat Niemann-Pick disease type C. Zevra plans to request a re-examination and submit supporting explanations, while continuing expanded access to generate real-world evidence. ZVRA shares closed at $9.53, down 23.92% on the day.
Over the past 7 days, alphai's AI scored 2 news stories mentioning ZVRA (ZEVRA THERAPEUTICS, INC.). Coverage has skewed bullish: 1 bullish, 1 neutral, and 0 bearish.
Recent ZVRA coverage spans regulation, financial news and earnings.
EU regulatory re-examination is a near-term binary catalyst for arimoclomol, with Q4 CHMP opinion timing.
Near-term focus is on commercial execution and regulatory path in Europe, with cash runway supporting ongoing arimoclomol and celiprolol Phase 3 work.
Regulatory setback in Europe increases approval risk and can pressure valuation until re-examination outcome is clearer.
A CHMP negative opinion is a regulatory setback that can delay or block European commercialization, increasing downside risk to timelines and valuation.
Exclusivity reinforcement reduces generic entry risk and supports longer revenue visibility.
alphai scores every news story that mentions ZVRA with an AI model for sentiment and relevance, and aggregates insider trades from ZEVRA THERAPEUTICS, INC.'s SEC EDGAR Form 4 filings. Figures refresh continuously.
Zevra Therapeutics (NASDAQ:ZVRA) reported Q2 updates on MIPLYFFA, including high refill, compliance and persistence, and payer coverage of 69% of covered lives. Net reimbursements were $9 million. In the EU, Zevra will re-examine arimoclomol after a CHMP negative opinion, with an expected Q4 decision. Cash was $260.2 million.
4 min readZEVRA THERAPEUTICS, INC. (ZVRA) filed an SEC Form 8-K — Results of Operations and Financial Condition. EX-99.1 2 zvra-20260805xex991earnings.htm EX-99.1 Document Exhibit 99.1 Zevra Reports Second Quarter 2026 Financial Results and Corporate Update $39.7 million net revenue for Q2 2026, driven by $30.2 million in revenue from MIPLYFFA 53% increase in total net revenue over Q2 2025
6 min readZevra Therapeutics said the EMA CHMP issued a negative opinion on its marketing authorization application for arimoclomol to treat Niemann-Pick disease type C. Zevra plans to request a re-examination and submit supporting explanations, while continuing expanded access to generate real-world evidence. ZVRA shares closed at $9.53, down 23.92% on the day.
3 min readZevra Therapeutics (NASDAQ: ZVRA) fell after the EMA CHMP issued a negative opinion on its marketing authorization application for arimoclomol to treat Niemann-Pick disease type C. Zevra said it will request a re-examination and provide supporting explanations, and it continues expanded access to support eligible patients and gather real-world evidence.
2 min readBiotech stocks rose Monday as investors reacted to clinical and regulatory updates. Tango Therapeutics (TNGX) jumped 52.97% after initial Phase 1/2 pancreatic cancer data showed 90% 6-month PFS; Alvotech (ALVO) gained 19.77% as the FDA accepted its Entyvio interchangeable biosimilar AVT16; Zevra (ZVRA) rose 13.95% on an Orange Book listing for MIPLYFFA.
7 min readZevra Therapeutics said it filed a patent for MIPLYFFA (arimoclomol) to be listed in the FDA’s Orange Book, with protection extending to 2041. The company said the Orange Book listing would strengthen MIPLYFFA’s exclusivity and could trigger an automatic stay on generic approvals if challenged. Zevra shares rose more than 9.5% on Monday.
3 min readZEVRA THERAPEUTICS, INC. (ZVRA) filed an SEC Form 8-K — Submission of Matters to a Vote of Security Holders. zvra-20260604 false 0001434647 0001434647 2026-06-04 2026-06-04 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 __________________________________________________________________________________________ FORM 8-K ____________________________________________
2 min readZevra Therapeutics (Nasdaq: ZVRA) said it granted inducement stock options to four new employees totaling 33,000 shares under its 2023 Employment Inducement Award Plan, approved by the Compensation Committee. Options vest over four years: 25% after the first anniversary of each employee’s start date, with the remainder in three equal annual installments, subject to continued employment.
2 min readZevra Therapeutics has sold its serdexmethylphenidate (SDX) portfolio, including AZSTARYS® and KP1077, to Commave Therapeutics SA for $50 million. This agreement resolves a lawsuit initiated by Commave in 2024 concerning a 2019 license agreement. Zevra stated that this transaction allows them to focus on their mission of providing therapies for rare diseases and they are now debt-free.
3 min readGeneDx has announced a new genetic testing program in partnership with Zevra Therapeutics to support patients with suspected Niemann-Pick Disease Type C (NPC). This program will expand access to GeneDx’s ExomeDx™ test, aiming to provide faster and more accurate diagnoses for NPC, a rare and often underdiagnosed inherited condition. Zevra Therapeutics will financially support the program, enabling eligible U.S. patients to receive the ExomeDx test at no charge and receive results within approximately three weeks.
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