Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical
company developing and delivering novel therapies for the
management of central nervous system (CNS) disorders, today
announced five presentations, including two featured oral plenary
presentations, on solriamfetol at SLEEP 2024, the 38th annual
meeting of the American Academy of Sleep Medicine (AASM) and the
Sleep Research Society (SRS), being held June 1-5, 2024, in
Houston, Texas.
“Cognitive functioning is an underappreciated
facet of sleep disorders. Often overshadowed by clinically defining
symptoms such as EDS, impaired cognition involves significant
burden to patient lives. The SHARP study of solriamfetol showed
improved cognitive functioning in participants with impaired
cognition associated with OSA and EDS,” said Hans Van Dongen, PhD,
Professor at Washington State University and presenting author of
the SHARP study plenary lecture. “In addition, solriamfetol
demonstrated improvements across measures of executive function,
memory, and processing speed.”
Details for the presentations are as
follows:
Title: Solriamfetol on
Cognition in Obstructive Sleep Apnea with Excessive Daytime
Sleepiness and Impaired CognitionLead Author: Hans
Van Dongen, PhD, Professor at Washington State
UniversityPlenary Session: O-09Plenary
Date/Time: Tuesday, June 4 from 9:15-9:30 a.m. Central
TimePoster Session: P-45Poster
Number: 390Poster Date/Time: Wednesday,
June 5 from 11-11:45 a.m. Central Time
Title: Effects of Solriamfetol
on Cognition on Patients with Excessive Daytime Sleepiness
Associated with NarcolepsyLead Author: Yaroslav
Winter, MD, Mainz Comprehensive Epilepsy and Sleep Medicine Center,
Department of Neurology, Johannes Gutenberg-University, Mainz,
GermanyPlenary Session: O-18Plenary
Date/Time: Tuesday, June 4 from 5-5:15 p.m. Central
TimePoster Session: P-13Poster
Number: 266Poster Date/Time: Monday, June
3 from 11-11:45 a.m. Central Time
Title: Solriamfetol and
Maintenance of Wakefulness Outcomes in Patients with Narcolepsy and
Obstructive Sleep ApneaLead Author: Dr. Michael
Thorpy, Director of the Sleep-Wake Disorders Center at the
Montefiore Medical Center and Professor of Neurology at Albert
Einstein College of MedicinePoster Session:
P-29Poster Number: 324Poster
Date/Time: Tuesday, June 4 from 11-11:45 a.m. Central
Time
Title: Real-world Use of
Solriamfetol for Excessive Daytime Sleepiness in Patients Reporting
Anxiety or DepressionLead Author: Ulf Kallweit is
Assistant Professor of Neurology at the University Witten/Herdecke,
Germany.Poster Session: P-39Poster
Number: 200Poster Date/Time: Wednesday,
June 5 from 11-11:45 a.m. Central Time
Title: SURWEY: Treatment of
Excessive Daytime Sleepiness with Solriamfetol: Initiation,
Titration, and Outcomes Lead Author: Samantha
Floam, DMD, Axsome TherapeuticsPoster Session:
P-29Poster Number: 325Poster
Date/Time: Tuesday, June 4 from 10-10:45 a.m. Central
Time
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® and Auvelity® products
and the success of our efforts to obtain any additional
indication(s) with respect to solriamfetol and/or 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 revenues or expenses), futility
analyses and receipt of interim results, which are not necessarily
indicative of the final results of our ongoing clinical trials,
and/or data readouts, 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 statements
regarding the timing of any NDA submission; 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 products and product
candidates, if approved; the Company’s anticipated capital
requirements, including the amount of capital required for the
continued commercialization of Sunosi and Auvelity and for the
Company’s commercial launch of its other product candidates, if
approved, 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 geo-political
conflicts or a global pandemic 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 Contacts:
Investors:Mark JacobsonChief Operating OfficerAxsome
Therapeutics, Inc.One World Trade Center, 22nd FloorNew York, NY
10007Tel: 212-332-3243Email: mjacobson@axsome.com
www.axsome.com
Media:Darren OplandDirector, Corporate CommunicationsAxsome
Therapeutics, Inc.One World Trade Center, 22nd FloorNew York, NY
10007Tel: 929-837-1065Email: dopland@axsome.com www.axsome.com
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