ZEVRA THERAPEUTICS, INC.

Zevra Therapeutics reported a 53% increase in Q2 2026 net revenue to $39.66 million. However, net income decreased to $8.75 million from $74.71 million in Q2 2025, primarily due to a large gain on a PRV sale in the prior year. For the six months ended June 30, 2026, the company recognized a $43.31 million gain from the sale of its SDX portfolio to Commave Therapeutics. Additionally, the European Medicines Agency's CHMP adopted a negative opinion regarding the Marketing Authorization Application for arimoclomol in July 2026, for which the company has requested a re-examination.

Zevra Therapeutics reported strong financial results for the second quarter ended June 30, 2026, with net revenue increasing 53% year-over-year to $39.7 million, primarily driven by MIPLYFFA sales. The company maintained a robust cash position of $260.2 million and highlighted significant progress in its commercial execution for MIPLYFFA and pipeline development for celiprolol. Zevra also announced a request for re-examination of its Marketing Authorisation Application for arimoclomol in Europe.

Zevra Therapeutics announced that its executive leadership team will present at the Canaccord Genuity 46th Annual Growth Conference on August 11, 2026, at 11:00 a.m. ET. The company's management will also be available for one-on-one meetings with registered attendees. A live webcast of the presentation will be available on Zevra's investor relations website.

Zevra Therapeutics announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a negative opinion regarding the Marketing Authorization Application (MAA) for arimoclomol, intended for Niemann-Pick disease type C (NPC). Despite this setback, Zevra plans to request a re-examination of the CHMP opinion and will submit a detailed explanation. The company remains committed to bringing arimoclomol to patients in Europe and continues to provide access through its global Expanded Access Program.

Zevra Therapeutics, Inc. announced it will report its second-quarter 2026 corporate and financial results on Wednesday, August 5, 2026. The company plans to issue a news release after market close, followed by a conference call and audio webcast at 4:30 p.m. ET on the same day. Details for accessing the webcast and dial-in information were provided for investors and interested parties.

Zevra Therapeutics announced the publication of results from its Phase 2/3 open-label pediatric substudy of arimoclomol (MIPLYFFA) in infants with Niemann-Pick disease type C (NPC). The study, published in Molecular Genetics and Metabolism Reports, evaluated arimoclomol in five children aged 12 to <24 months, demonstrating that the drug was generally well tolerated with no new safety signals. Pharmacokinetic results were consistent with older pediatric populations, providing preliminary evidence to support earlier treatment initiation in this age group. MIPLYFFA was approved by the U.S. FDA on September 20, 2024, and Zevra has also submitted a Marketing Authorization Application to the European Medicines Agency.

Zevra Therapeutics announced that its Chief Medical Officer, Adrian Quartel, M.D., will be stepping down from his position due to personal reasons, effective July 3, 2026. Dr. Quartel will continue to support the company as a consultant through December 31, 2026, to ensure a seamless transition while Zevra searches for a new CMO. The company expressed gratitude for his contributions, including the FDA approval and launch of MIPLYFFA, and noted that its regulatory milestones, such as the arimoclomol MAA and celiprolol Phase 3 trial, remain on track.

Zevra Therapeutics announced the submission of U.S. Patent No. 11,707,456 for MIPLYFFA® (arimoclomol) to the FDA for Orange Book listing. This patent provides intellectual property protection until November 19, 2041, strengthening the long-term value of MIPLYFFA for Niemann-Pick disease type C. The company also has a pending patent term extension for another patent expiring in 2029.

Zevra Therapeutics, Inc. held its 2026 Annual Meeting of Stockholders on June 4, 2026. Stockholders elected Douglas W. Calder and Corey Watton as Class II directors and ratified Ernst & Young LLP as the independent registered public accounting firm for fiscal year 2026. However, a proposal to amend the Company's Restated Certificate of Incorporation to phase out the classified Board structure and provide for annual director elections did not receive the required affirmative vote of more than 66 2/3% of outstanding common stock.

Zevra Therapeutics, Inc. announced it has granted options to purchase an aggregate of 33,000 shares of its common stock to four new employees. These "Inducement Awards" are issued under the Company's 2023 Employment Inducement Award Plan and vest over four years. The grants were approved by the Compensation Committee as a material inducement for the individuals to join Zevra, in accordance with Nasdaq rules. Zevra is a commercial-stage company focused on developing life-changing therapeutics for rare diseases.