Zevra Therapeutics (NasdaqGS: ZVRA) (“Zevra” or the “Company” and
formerly KemPharm, Inc.), a rare disease therapeutics company,
announced today that it will begin trading under the new ticker
symbol “ZVRA” on the Nasdaq Global Select Market at market open
today, March 1, 2023.
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 U.S.,
primarily affects children and is often fatal, causing progressive
loss of brain, nerve, liver, spleen, bone marrow, and lung
functions. The U.S. Food and Drug Administration (“FDA”) has
granted arimoclomol orphan drug designation, Fast Track
designation, and rare pediatric disease designation for the
treatment of NPC.
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.
About ZevraZevra 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 U.S. Food and Drug
Administration (“FDA”), and orphan medicinal product designation
for the treatment of NPC by the European Medicines Agency
(“EMA”).
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 U.S. Drug Enforcement Agency (“DEA”) has classified SDX as
a Schedule IV controlled substance based on evidence suggesting SDX
has a lower potential for abuse when compared to d-MPH, a Schedule
II controlled substance.
Early access programs are made available by
Zevra Therapeutics, Inc. and its affiliates and are subject to the
Company's Early Access Program (“EAP”) policy as published on its
website at zevra.com. Participation in these programs is subject to
the laws and regulations of each jurisdiction under which each
respective program is operated. Eligibility for participation in
any such program is at the treating physician's discretion.
Caution Concerning Forward-Looking
StatementsThis 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 KemPharm)
Annual Report on Form 10-K for the year ended December 31, 2021, as
updated by Zevra’s (formerly KemPharm) Quarterly Report on Form
10-Q for the three months ended September 30, 2022, and Zevra’s
(formerly KemPharm) other filings with the Securities and Exchange
Commission. While we may elect to update such forward-looking
statements at some point in the future, except as required by law,
we disclaim any obligation to do so, even if subsequent events
cause our views to change. Although we believe the expectations
reflected in such forward-looking statements are reasonable, we
cannot assure that such expectations will prove correct. These
forward-looking statements should not be relied upon as
representing our views as of any date after the date of this press
release.
Contacts:
Nichol Ochsner+1 (732) 754-2545nochsner@zevra.com
Jennifer Arcure +1 (917)
603-0681Jennifer.arcure@evokegroup.com
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