Axsome Therapeutics to Ring the NASDAQ Stock Market Opening Bell Today
27 October 2022 - 10:00PM
Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical
company developing and delivering novel therapies for the
management of central nervous system (CNS) disorders, today
announced that Herriot Tabuteau, MD, Axsome’s Chief Executive
Officer, the rest of the management team, along with other Axsome
team members, will ring the opening bell of the NASDAQ Stock Market
today, Thursday, October 27, 2022, to commemorate the availability
of AUVELITY™ in the United States by prescription.
“This is a momentous time in Axsome’s history as
we have now launched Auvelity. With the relaunch of Sunosi we are
now making available to patients two treatments for mental
conditions,” said Herriot Tabuteau, MD, Chief Executive Officer of
Axsome. “We are honored to ring NASDAQ’s opening bell to
commemorate the availability of Auvelity by prescription and the
hard work and dedication of the Axsome team which made it possible.
Axsome’s commitment to discovering, developing, and delivering new
treatments for those living with mental health conditions remains
firm as we continue to advance the rest of our robust
pipeline.”
The ceremony will take place at the Nasdaq
MarketSite, 4 Times Square, New York, NY. The live ceremonies will
begin at 9:20 AM Eastern Time and can be viewed at
https://www.nasdaq.com/marketsite/bell-ringing-ceremony.
About AUVELITY™
AUVELITY is a novel, oral, NMDA receptor
antagonist with multimodal activity approved for the treatment of
MDD in adults. AUVELITY is a proprietary extended-release oral
tablet containing dextromethorphan HBr (45 mg) and bupropion HCl
(105 mg). The dextromethorphan component of AUVELITY is an
antagonist of the NMDA receptor (an ionotropic glutamate receptor)
and a sigma-1 receptor agonist. These actions are thought to
modulate glutamatergic neurotransmission. The bupropion component
of AUVELITY is an aminoketone and CYP2D6 inhibitor which serves to
increase and prolong the blood levels of dextromethorphan. The
exact mechanism of action of Auvelity in the treatment of
depression is unclear. AUVELITY received Breakthrough Therapy
designation from the FDA for the treatment of MDD. Please see full
Prescribing Information, including Boxed
Warning for suicidal thoughts and behaviors, and
Medication Guide.
About SUNOSI®
Sunosi (solriamfetol 75 mg and 150 mg) is a
dual-acting dopamine and norepinephrine reuptake inhibitor
indicated to improve wakefulness in adult patients with excessive
daytime sleepiness (EDS) associated with narcolepsy or obstructive
sleep apnea (OSA). Sunosi received U.S. Food and Drug
Administration approval on March 20, 2019 to improve wakefulness in
adult patients with EDS associated with narcolepsy or OSA and was
designated a Schedule IV medicine by the U.S. Drug Enforcement
Agency on June 17, 2019. SK Biopharmaceuticals Co., Ltd., the
discoverer of the compound, maintains rights in 12 Asian markets,
including Korea, China and Japan. Sunosi has orphan drug
designation for narcolepsy in the United States. Please see full
Prescribing Information and Medication
Guide.
About Axsome Therapeutics,
Inc.
Axsome Therapeutics, Inc. is a biopharmaceutical
company developing and delivering novel therapies for central
nervous system (CNS) conditions that have limited treatment
options. Through development of therapeutic options with novel
mechanisms of action, we are transforming the approach to treating
CNS conditions. At Axsome, we are committed to developing products
that meaningfully improve the lives of patients and provide new
therapeutic options for physicians. For more information, please
visit the Company’s website at axsome.com. The Company may
occasionally disseminate material, nonpublic information on the
company website.
Forward Looking Statements
Certain matters discussed in this press release
are “forward-looking statements”. We may, in some cases, use terms
such as “predicts,” “believes,” “potential,” “continue,”
“estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,”
“could,” “might,” “will,” “should” or other words that convey
uncertainty of future events or outcomes to identify these
forward-looking statements. In particular, the Company’s statements
regarding trends and potential future results are examples of such
forward-looking statements. The forward-looking statements include
risks and uncertainties, including, but not limited to, the
continued commercial success of our Sunosi® product and the success
of our efforts to obtain any additional indication(s) with respect
to Sunosi; the commercial success of our Auvelity™ product and the
success of our efforts to obtain any additional indication(s) with
respect to AXS-05, the success, timing and cost of our ongoing
clinical trials and anticipated clinical trials for our current
product candidates, including statements regarding the timing of
initiation, pace of enrollment and completion of the trials
(including our ability to fully fund our disclosed clinical trials,
which assumes no material changes to our currently projected
expenses), futility analyses and receipt of interim results, which
are not necessarily indicative of the final results of our ongoing
clinical trials, and the number or type of studies or nature of
results necessary to support the filing of a new drug application
(“NDA”) for any of our current product candidates; our ability to
fund additional clinical trials to continue the advancement of our
product candidates; the timing of and our ability to obtain and
maintain U.S. Food and Drug Administration (“FDA”) or other
regulatory authority approval of, or other action with respect to,
our product candidates (including, but not limited to,; whether
issues identified by FDA in the complete response letter may impact
the potential approvability of the Company’s NDA for AXS-07 for the
acute treatment of migraine in adults with or without aura,
pursuant to our special protocol assessment for the MOMENTUM
clinical trial; the Company’s ability to successfully defend its
intellectual property or obtain the necessary licenses at a cost
acceptable to the Company, if at all; the successful implementation
of the Company’s research and development programs and
collaborations; the success of the Company’s license agreements;
the acceptance by the market of the Company’s product candidates,
if approved; the Company’s anticipated capital requirements,
including the amount of capital required for the successful
commercialization of Sunosi and Auvelity and for the Company’s
commercial launch of its other product candidates, and the
potential impact on the Company’s anticipated cash runway;
unforeseen circumstances or other disruptions to normal business
operations arising from or related to COVID-19; and other factors,
including general economic conditions and regulatory developments,
not within the Company’s control. The factors discussed herein
could cause actual results and developments to be materially
different from those expressed in or implied by such statements.
The forward-looking statements are made only as of the date of this
press release and the Company undertakes no obligation to publicly
update such forward-looking statements to reflect subsequent events
or circumstance.
Axsome Contact: Mark JacobsonChief Operating
Officer Axsome Therapeutics, Inc.22 Cortlandt Street, 16th FloorNew
York, NY 10007Tel: 212-332-3243Email: mjacobson@axsome.com
www.axsome.com
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