CORRECTION – KemPharm Announces Corporate Name Change to Zevra Therapeutics
New name, Greek for “zebra,” is the internationally-recognized symbol for the rare disease community
Branding reflects Company’s commitment to making rare disease therapies available through its research, development, and commercialization efforts
The Company’s common shares will trade on The Nasdaq Global Select Market under the new ticker symbol “ZVRA” starting on or about
“The adoption of the name Zevra, the Greek word for zebra, is an important step in our journey to become a leading rare disease company since the zebra is the recognized symbol of the rare disease community around the world,” said
In addition to arimoclomol, Zevra is 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.
“The launch of the Zevra brand today marks the next key step in our evolution into a commercially-focused rare disease therapeutics company. People with rare diseases are desperately awaiting treatments, and even one drug that doesn’t reach them is one drug too many,” said
Zevra looks ahead to key milestones in 2023, including the resubmission of arimoclomol New Drug Application (“NDA”) to the FDA as early as Q3 2023, an interim and final data readout for KP1077 in IH, and the potential achievement of certain commercial sales milestones for our partnered asset, AZSTARYS®.
Along with the new name, the Company has a new logo and website. Visit 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 Neimann-Pick type C (“NPC”), has been granted orphan drug designation, Fast Track designation and rare pediatric disease designation for 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, 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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