Axsome Therapeutics Announces AXS-07 Phase 3 Migraine Trial Results Selected by the American Academy of Neurology Science Com...
September 17 2020 - 7:00AM
Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical
company developing novel therapies for the management of central
nervous system (CNS) disorders, today announced that Phase 3 data
for AXS-07 in the acute treatment of migraine has been selected as
a featured presentation at the 2020 American Academy of Neurology
(AAN) Science Highlights platform, to be held virtually September
23, 2020 at 12:15 PM Central Time. AXS-07 (MoSEIC™
meloxicam/rizatriptan) is Axsome’s novel, oral, multi-mechanistic
investigational medicine for the acute treatment of migraine. The
presentation will highlight new insights from the Phase 3 MOMENTUM
trial of AXS-07, and will be followed with live Q&A.
The AAN Science Committee reviewed over 150
late-breaking, or Emerging Science, abstracts and selected 12 to be
featured presentations on the new 2020 AAN Science Highlights
platform. The results of the Phase 3 MOMENTUM trial were one of the
12 selected abstracts. According to the AAN, the selected abstracts
contain timely, significant, and innovative content.
Details of the presentation are as follows:
Title: Efficacy and Safety of
AXS-07 for the Acute Treatment of Migraine: Results from the
MOMENTUM (Maximizing Outcomes in Treating Acute Migraine) Phase 3
Randomized, Double-blind, Active- and Placebo-controlled
StudySession: Emerging Science: Alzheimer's,
Migraine, ALS and CIDPDate: Wednesday September
23, 2020Time: 12:15 – 12:30 PM Central
TimeLocation: The 2020 AAN Science Highlights
virtual platform will be available to everyone. Attendees will be
asked to register to access the session at:
https://www.aan.com/education-and-research/research/2020-aan-science-highlights/.
A recording of the webinar will be available on the AAN Science
Highlights platform following the session.
A copy of the presentation will be available
shortly after the meeting on Axsome’s website at
www.axsome.com.
About AXS-07
AXS-07 is a novel, oral, multi-mechanistic,
investigational medicine under development for the acute treatment
of migraine. AXS-07 consists of MoSEIC™ meloxicam and rizatriptan.
Meloxicam is a new molecular entity for migraine enabled by
Axsome’s MoSEIC (Molecular Solubility Enhanced Inclusion Complex)
technology, which results in rapid absorption of meloxicam while
maintaining a long plasma half-life. Meloxicam is a COX-2
preferential non-steroidal anti-inflammatory drug and rizatriptan
is a 5-HT1B/1D agonist. AXS-07 is designed to provide rapid,
enhanced and consistent relief of migraine, with reduced symptom
recurrence. AXS-07 is not approved by the FDA.
About Axsome Therapeutics,
Inc.
Axsome Therapeutics, Inc. is a biopharmaceutical
company developing novel therapies for the management of central
nervous system (CNS) disorders for which there are limited
treatment options. For the many people facing unsatisfactory
treatments for CNS disorders, Axsome accelerates the invention and
adoption of life-changing medicines. Axsome’s core CNS product
candidate portfolio includes five clinical-stage candidates,
AXS-05, AXS-07, AXS-09, AXS-12, and AXS-14. AXS-05 is being
developed for major depressive disorder (MDD), treatment resistant
depression (TRD), Alzheimer’s disease (AD) agitation, and as a
treatment for smoking cessation. AXS-07 is being developed for the
acute treatment of migraine. AXS-12 is being developed for the
treatment of narcolepsy. AXS-14 is being developed for
fibromyalgia. AXS-05, AXS-07, AXS-09, AXS-12, and AXS-14 are
investigational drug products not approved by the FDA. 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
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, FDA’s agreement with the Company’s
discontinuation of the bupropion treatment arm of the ADVANCE-1
study in accordance with the independent data monitoring
committee’s recommendations); the potential for the MOMENTUM
clinical trial to provide a basis for approval of AXS-07 for the
acute treatment of migraine in adults with or without aura,
pursuant to our special protocol assessment; the potential for the
ASCEND clinical trial, combined with the GEMINI clinical trial
results, to provide a basis for approval of AXS-05 for the
treatment of major depressive disorder and accelerate its
development timeline and commercial path to patients; 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 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 Jacobson Chief Operating
Officer Axsome Therapeutics, Inc. 22 Cortlandt Street, 16th Floor
New York, NY 10007 Tel: 212-332-3243 Email: mjacobson@axsome.com
www.axsome.com
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