Press release
Zevra Therapeutics Reports Second Quarter 2024 Financial Results and Corporate Highlights
FDA advisory committee voted favorably that the data support arimoclomol as effective treatment for patients with NPC; PDUFA date of September 21, 2024 Pro
About this update from Zevra Therapeutics, Inc.
[{"type":"text","content":"FDA advisory committee voted favorably that the data support arimoclomol as effective treatment for patients with NPC; PDUFA date of September 21, 2024 Pro forma June 30, 2024, cash, cash equivalents, investments and net proceeds from underwritten public offering total $113.8 million following the closing on August 12, 2024 Conference call scheduled for today, August 13, 2024, at 4:30 p.m. ET CELEBRATION, Fla., Aug. 13, 2024 (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 second quarter ended June 30, 2024. “During the second quarter, we made steady progress executing on our strategic objectives,” said Neil F. McFarlane, President and Chief Executive Officer of Zevra. “We are encouraged by favorable vote from the FDA’s Genetic Metabolic Diseases Advisory Committee, that data presented support that arimoclomol is effective in the treatment in patients with Niemann Pick disease type C. While the vote is non-binding, we believe it is an important factor as the FDA completes its consideration for approval. Additionally, we continue the launch of OLPRUVA with a keen focus on driving patient awareness and intend to use the same commercial team to launch arimoclomol, if approved. Additionally, we expect to meet with the FDA to discuss the design of a pivotal Phase 3 trial to study KP1077 in idiopathic hypersomnia at the end of third quarter.” “We continue to be prudent in our capital allocation as we focus on creating long-term value for stockholders,” said R. LaDuane Clifton, Zevra’s Chief Financial Officer and Treasurer. “Our recent underwritten offering provided net proceeds to the Company of $64.5 million, along with attracting a cadre of institutional investors well known as long term supporters of innovation and building momentum as we lean into our near-term catalysts while also extending our cash runway.” Q2 2024 Corporate Highlights: Arimoclomol On August 2, 2024, the U.S. Food and Drug Administration’s (FDA) newly formed Genetic Metabolic Diseases Advisory Committee (the “GeMDAC”) convened for the first time and discussed the benefits and risks of arimoclomol.The GeMDAC reviewed comments received from independent experts, NPC patients, and patient advocacy group representative...