Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical
company developing and delivering novel therapies for the
management of central nervous system (CNS) disorders, today
announced presentations highlighting its innovative psychiatry and
neurology pipeline at the American Academy of Neurology (AAN) 2024
annual meeting, being held April 13-18, 2024, in Denver, Colorado.
The presentations include an oral presentation during the Clinical
Trials Plenary Session of data from the ACCORD Phase 3 trial of
AXS-05 in Alzheimer’s disease agitation (ADA). Presentations
related to the AXS-07 clinical program in migraine include new
pooled efficacy data from the MOMENTUM and INTERCEPT Phase 3
trials. Additionally, there will be data presentations on cognition
and sleep from the solriamfetol clinical program.
Details for the presentations are as
follows:
Alzheimer’s Disease
Agitation
Title: Efficacy and Safety Of
AXS-05 in Agitation Associated with Alzheimer’s Disease: Results
From ACCORD, a Phase 3, Double-Blind, Placebo-Controlled, Relapse
Prevention TrialPresentation Date and Time:
Tuesday, April 16 from 9:15 a.m. to 11:30 a.m. Mountain
TimeLead Author: Anton P. Porsteinsson, MD,
William B. and Sheila Konar Professor of Psychiatry at the
University of Rochester, School of Medicine and
DentistrySession Name: PL5: Clinical Trials
Plenary SessionProgram Number: PL5.005
Migraine
Title: Combined Efficacy and
Safety of AXS-07 (MOSEICTM Meloxicam and Rizatriptan) in Two Phase
3 Clinical TrialsPresentation Date and Time:
Tuesday, April 16 from 11:45 a.m. to 12:45 p.m. Mountain
TimeLead Author: Stewert Tepper, MD, Professor of
Neurology at the Geisel School of Medicine at
DartmouthSession Name: P7: Headache: Therapeutics
2 Program Number: P7.002
Title: EMERGE Study: An
Open-label Evaluation of the Efficacy and Safety of AXS-07 (MoSEIC™
meloxicam-rizatriptan) for Migraine in Adults with Prior Inadequate
Response to an Oral CGRP InhibitorPresentation Date and
Time: Tuesday, April 16 from 8 a.m. to 9 a.m. Mountain
TimeLead Author: Peter McAllister, MD, Director of
the New England Center for Neurology and HeadacheSession
Name: P6: Headache: Therapeutics 1 Program
Number: P6.006
Cognition
Title: Solriamfetol Improves
Cognitive Performance in Preclinical Models of Sleep Apnea and in a
Randomized Placebo-controlled Study of Sleep Apnea Participants
(SHARP)Presentation Date and Time: Wednesday,
April 17 from 8 a.m. to 9 a.m. Mountain TimeLead
Author: David Gozal, MD, MBA, Marie M. and Harry L. Smith
Endowed Chair and the Chairman of the Department of Child Health at
the University of MissouriSession Name: P9: Sleep
2 Program Number: P9.004
Sleep
Title: Solriamfetol for
Excessive Sleepiness in Narcolepsy and Obstructive Sleep Apnea:
Effect Sizes and Numbers Needed to Treat or
HarmPresentation Date and Time: Wednesday, April
17 from 11:45 a.m. to 12:45 p.m. Mountain TimeLead
Author: Craig Chepke, MD, DFAPA, SUNY Upstate Medical
UniversitySession Name: P10: Sleep 3
Program Number: P10.009
Title: SURWEY Study of
Solriamfetol: Initiation, Titration, Safety, Efficacy, and
Follow-up Experience for Patients with OSA in
GermanyPresentation Date and Time: Wednesday,
April 17 from 8 a.m. to 9 a.m. Mountain TimeLead
Author: Yaroslav Winter, MD, University of Medicine
MainzSession Name: P9: Sleep 2 Program
Number: P9.010
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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