Press release
Zevra Therapeutics Reports Corporate Updates and Third Quarter 2023 Financial Results
Arimoclomol NDA resubmission remains on track for end of year filing Proposed acquisition of Acer Therapeutics on track to close Q4 2023 and will diversify
About this update from Zevra Therapeutics, Inc.
[{"type":"text","content":"Arimoclomol NDA resubmission remains on track for end of year filing Proposed acquisition of Acer Therapeutics on track to close Q4 2023 and will diversify Zevra’s revenue with FDA-approved OLPRUVA® for urea cycle disorders (UCDs) Net revenue of $2.9M for Q3 2023 Ended Q3 2023 with $83.4M in cash, cash equivalents, and investments, supporting our forecasted cash runway into 2026 Conference call and live audio webcast scheduled for today, Nov 7, 2023, 8:00 a.m. ET CELEBRATION, Fla., Nov. 07, 2023 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a rare disease therapeutics company, today provided corporate updates and reported its financial results for the quarter ended September 30, 2023. “This is a pivotal time for Zevra as we advance our pipeline programs toward multiple potential value inflection points,” said Neil F. McFarlane, President and Chief Executive Officer of Zevra. “As we look to the end of 2023 and into 2024, we’re focused on three key priorities. First, to close the proposed Acer acquisition and, if consummated, deliver value to patients by commercializing OLPRUVA. Second, to resubmit the arimoclomol NDA. Third, to complete the Phase 2 trial in idiopathic hypersomnia and prepare to advance KP1077 into Phase 3. We are making solid progress towards achieving our mission of building a patient-focused leading rare disease company.” Recent Business and Corporate Highlights: Corporate: Neil F. McFarlane was named President and Chief Executive Officer of Zevra and appointed to the Board of Directors on October 10, 2023. Neil succeeds Christal M.M. Mickle who has been serving as interim CEO and President since June 2023, and who will continue serving in her role as Chief Development Officer. Joseph B. Saluri’s previously announced retirement from the Board of Directors also became effective contemporaneous with Neil’s appointment.Arimoclomol: The new drug application (NDA) for arimoclomol is on track to be resubmitted to the U.S. Food and Drug Administration (FDA) by the end of this year. Arimoclomol is an investigational therapeutic candidate for the treatment of Niemann-Pick disease type C (NPC), an ultra-rare, genetic, progressive and fatal neurological disease. If approved, arimoclomol has the potential to be a first-in-class, orally-delivered treatment for NPC. Because a signific...