Zevra Therapeutics Begins Trading as ZVRA
Company’s common stock will begin trading on the Nasdaq Global Select Market under the new ticker symbol “ZVRA” starting today,
The Company’s new corporate name, along with the corresponding ticker symbol, embody Zevra’s unwavering commitment to the rare disease community as it pursues its primary mission to deliver life-changing treatments to people with rare conditions, their families and caregivers who desperately need better options.
Zevra is currently developing arimoclomol, an orally-delivered, first-in-class investigational product candidate for the treatment of Niemann-Pick type C disease (“NPC”). NPC, a rare disease with no currently approved treatments in the
In addition, Zevra is also advancing KP1077, a product candidate based on Zevra’s prodrug of d-methylphenidate, serdexmethylphenidate (“SDX”), which is currently being evaluated in a Phase 2 trial for the treatment of idiopathic hypersomnia (“IH”), a rare sleep disorder. Pending the results from that trial, the Company plans to conduct a pivotal Phase 3 study in IH, with the potential to study an expanded indication in narcolepsy.
Zevra expects several key milestones in 2023, including the planned resubmission of the New Drug Application (“NDA”) for arimoclomol to the FDA as early as Q3 2023, an interim and final data readout for KP1077 in IH, and the potential achievement of one or more certain commercial sales milestones for our partnered asset, AZSTARYS®, during FY 2023.
Visit Zevra’s new corporate website at zevra.com to learn more.
Zevra Therapeutics is a rare disease company melding science, data, and patient need to create transformational therapies for diseases with limited or no treatment options. With unique, data-driven clinical, regulatory, and commercialization strategies, the Company is overcoming complex drug development challenges to bring much-needed therapies to patients.
Arimoclomol, Zevra’s orally-delivered, first-in-class investigational product candidate for the treatment of Niemann-Pick disease type C (“NPC”), has been granted orphan drug designation, Fast Track designation and rare pediatric disease designation for the treatment of NPC by the
KP1077 is Zevra’s lead clinical candidate being developed to treat idiopathic hypersomnia (“IH”) and narcolepsy. KP1077 is comprised solely of serdexmethylphenidate (“SDX”), Zevra’s proprietary prodrug of d-methylphenidate (“d-MPH”). The FDA has granted KP1077 orphan drug designation for the treatment of IH, and the
Early access programs are made available by
Caution Concerning Forward-Looking Statements
This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that do not relate solely to historical or current facts, including without limitation, and which can be identified by the use of words such as "may," "will," "expect," "project," "estimate," "anticipate," "plan," "believe," "potential," "should," "continue," "could," "intend," "target," "predict," or the negative versions of those words or other comparable words or expressions, although not all forward-looking statements contain these identifying words or expressions. Forward-looking statements are not guarantees of future actions or performance. These forward-looking statements include statements regarding: the promise and potential impact of our preclinical or clinical trial data, including without limitation the initiation, timing, and results of any clinical trials or readouts, the timing or results of any Investigational New Drug (“IND”) applications and New Drug Application (“NDA”) submissions for arimoclomol, KP1077, or any other product candidates for any specific disease indication or at any dosage, the potential achievement of commercial sales milestones for AZSTARYS and timing thereof, and our strategic and product development objectives. These forward-looking statements are based on information currently available to Zevra and its current plans or expectations. They are subject to several known and unknown uncertainties, risks, and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. These and other important factors are described in detail in the "Risk Factors" section of Zevra’s (formerly
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