$ZVRA

Zevra Therapeutics (ZVRA) presented at the Morgan Stanley conference, highlighting growth in its rare-disease strategy. MIPLYFFA has 184 U.S. prescriptions, 52-61% of diagnosed patients. The NPC market may be larger than initially thought. The company has $260M in cash, is debt-free, and expects EMA review clarity by Q4 2024. Celiprolol's Phase III trial is 44% enrolled but faces slower-than-expected event rates.

Zevra Therapeutics (ZVRA) will present long-term data on MIPLYFFA (arimoclomol) for Niemann-Pick disease at SSIEM 2026. Data from U.S. and German programs showed sustained stabilization and safety. MIPLYFFA was approved in September 2024. ZVRA stock closed at $11.65, up 1.29% in pre-market.

Watton Corey Michael sold 12,300 shares of ZEVRA THERAPEUTICS, INC. (ZVRA) at $11.25 ($0.14M total) on 2026-08-10.

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. 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 Operational execution fueled strong cash position of $260.2

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.

Zevra 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.

Biotech 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.

Zevra 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.

ZEVRA 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 ____________________________________________