Welcome to our dedicated page for Zevra Therapeutics news (Ticker: ZVRA), a resource for investors and traders seeking the latest updates and insights on Zevra Therapeutics stock.
Zevra Therapeutics reports developments as a commercial-stage biopharmaceutical company focused on therapies for rare diseases. Recurring updates center on MIPLYFFA (arimoclomol), its U.S.-approved treatment for Niemann-Pick disease type C, including commercialization, patient access, regulatory activity and diagnostic-support initiatives tied to NPC.
Zevra news also covers financial results, pipeline programs in rare diseases such as vascular Ehlers-Danlos syndrome, and corporate actions that shape its portfolio. Recent company updates include the completed sale of the serdexmethylphenidate, or SDX, portfolio, including AZSTARYS and KP1077, as well as governance and executive-compensation announcements under Nasdaq rules.
Zevra Therapeutics (NasdaqGS: ZVRA) reported that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a negative opinion on its Marketing Authorization Application for arimoclomol to treat Niemann-Pick disease type C (NPC) in the European Union.
According to the company, Zevra plans to request a re-examination of the CHMP opinion and submit a detailed justification. Zevra continues to provide arimoclomol to eligible patients via its global Expanded Access Program, which also generates real-world evidence. The company notes that updated international NPC management guidelines highlight arimoclomol as an important treatment option.
Zevra Therapeutics (NasdaqGS: ZVRA) will release its Q2 2026 corporate and financial results on Wednesday, August 5, 2026, via news release after market close, followed by a conference call and audio webcast at 4:30 p.m. ET.
According to Zevra, the live webcast and a 90-day replay will be available on the “Events & Presentations” page in the Investor Relations section of investors.zevra.com. Investors can also join via telephone using U.S. dial-in (800) 274-8461, international dial-in +1 (203) 518-9814, and Conference ID ZVRAQ226.
Zevra Therapeutics (Nasdaq: ZVRA) reported positive data for MIPLYFFA (arimoclomol) from a phase 2/3 open-label pediatric substudy in infants with Niemann-Pick disease type C.
The 5‑patient study (ages 12–<24 months) found arimoclomol, added to miglustat, was generally well tolerated with no new safety signals and pharmacokinetics consistent with older pediatric groups.
Zevra Therapeutics (NasdaqGS: ZVRA) announced that Chief Medical Officer Adrian Quartel will step down for personal reasons effective July 3, 2026. He will remain a consultant through December 31, 2026 while Zevra searches for a new CMO and manages the transition.
Zevra reports it remains on track with key regulatory milestones, including an EMA review of its arimoclomol MAA for Niemann-Pick disease type C and an ongoing Phase 3 celiprolol trial in Vascular Ehlers-Danlos Syndrome, with further FDA discussions planned in the second half of 2026.
Zevra Therapeutics (NasdaqGS: ZVRA) submitted U.S. Patent No. 11,707,456 for MIPLYFFA (arimoclomol) to the FDA for Orange Book listing. The patent expires November 19, 2041, aiming to strengthen exclusivity for treating Niemann-Pick disease type C.
A separate patent term extension request for U.S. Patent No. 11,045,460, currently expiring in 2029, remains pending with the U.S. Patent and Trademark Office.
Zevra Therapeutics (NasdaqGS: ZVRA) granted stock options to four new employees under its 2023 Employment Inducement Award Plan, consistent with Nasdaq Rule 5635(c)(4).
The options cover an aggregate of 33,000 shares, vesting over four years with 25% after one year and the balance in three equal annual installments.
Zevra Therapeutics (NasdaqGS: ZVRA) will present at the H.C. Wainwright BioConnect Investor Conference in New York on May 19, 2026, at 9:00 a.m. ET.
Executive leadership will present and hold one-on-one meetings, with a live webcast available via the Investor Relations section of Zevra’s website.
Zevra (NasdaqGS: ZVRA) reported Q1 2026 results on May 6, 2026. Net revenue was $36.2 million, up 78% year-over-year, including $24.6 million from MIPLYFFA. The company completed a $50.0 million sale of its SDX portfolio and prepaid a $63.1 million term loan, leaving cash of $236.8 million.
Pipeline updates include Phase 3 DiSCOVER enrollment progress (62 patients, two events) and an EMA review of arimoclomol for NPC; a conference call was held May 6, 2026.
Zevra Therapeutics (NasdaqGS: ZVRA) will report first-quarter 2026 corporate and financial results on Wednesday, May 6, 2026 via a news release after the market close and host a conference call/audio webcast at 4:30 p.m. ET.
A link and replay (available for 90 days beginning ~5:30 p.m. ET) will be on the Events & Presentations page at investors.zevra.com. Telephone dial-in and Conference ID ZVRAQ126 are provided for participants.
Zevra Therapeutics (Nasdaq: ZVRA) granted an inducement equity award to new CFO Justin Renz effective March 18, 2026 under its 2023 Employment Inducement Award Plan.
The company approved a new-hire option for 300,000 shares with a 10-year term, exercise price of $9.55 (closing price on March 18, 2026), and four-year vesting subject to continued service. The award was approved under Nasdaq Rule 5635(c)(4).