Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage
biopharmaceutical company developing novel therapies for the
management of central nervous system (CNS) disorders, will
participate in the 2019 Cantor Global Healthcare Conference on
Thursday, October 3, 2019. Herriot Tabuteau, MD, Axsome’s Chief
Executive Officer, will participate in a fireside chat at 3:00 PM
Eastern Time. The conference will be held at the InterContinental
New York Barclay in New York, NY.
Dr. Tabuteau will provide the following update
on the Company’s continued progress during the presentation:
AXS-05: AXS-05
(dextromethorphan/bupropion modulated delivery tablet) is Axsome’s
novel, oral, investigational NMDA receptor antagonist with
multimodal activity being developed for the following indications:
treatment resistant depression (TRD), major depressive disorder
(MDD), Alzheimer’s disease (AD) agitation, and smoking cessation.
AXS-05 has been granted U.S. Food and Drug Administration (FDA)
Breakthrough Therapy designation for the treatment of MDD and Fast
Track designations for the treatment of TRD and for the treatment
of AD agitation.
Depression
- To date, approximately 75% of the
targeted number of patients have been randomized into the GEMINI
Phase 3 placebo-controlled trial of AXS-05 in MDD. Axsome remains
on track to report topline efficacy results from both the GEMINI
trial and the STRIDE-1 trial of AXS-05 in TRD in the fourth quarter
of 2019.
- An NDA filing for AXS-05 in the treatment of MDD is targeted
for the second half of 2020.
Alzheimer’s Disease Agitation
- To date, approximately 65% of the
targeted number of patients have been randomized into the ADVANCE-1
Phase 2/3 trial of AXS-05 in agitation associated with Alzheimer’s
disease. Axsome continues to anticipate topline results from the
ADVANCE-1 trial in the first half of 2020.
AXS-07: AXS-07 (MoSEIC™
meloxicam/rizatriptan) is Axsome’s novel, oral, investigational
medicine with distinct dual mechanisms of action being developed
for the acute treatment of migraine.
- To date, more than 80% of the
targeted number of patients have been randomized into the MOMENTUM
Phase 3 trial of AXS-07 in the acute treatment of migraine.
MOMENTUM is being conducted pursuant to an FDA Special Protocol
Assessment (SPA). Axsome remains on track to report topline results
from the MOMENTUM trial in the fourth quarter of 2019.
- An NDA filing for AXS-07 in the acute treatment of migraine is
targeted for the second half of 2020.
AXS-12: AXS-12 (reboxetine) is
Axsome’s novel, oral, potent and highly selective norepinephrine
reuptake inhibitor being developed for the treatment of narcolepsy.
AXS-12 has been granted Orphan Drug Designation by the FDA for the
treatment of narcolepsy.
- To date, 70% of the targeted number
of patients have been randomized into the CONCERT Phase 2 trial of
AXS-12 in patients with narcolepsy. Axsome remains on track to
report topline results from the CONCERT trial in the fourth quarter
of 2019.
Financial Update
- Axsome believes that its current
cash will be sufficient to fund the Company’s anticipated
operations, based on its current operating plans, into the fourth
quarter of 2021, well beyond the readout of all of the above
ongoing clinical trials.
- As previously disclosed, Axsome currently does not anticipate
future equity financings prior to the readout from its Phase 3
trials.
A live webcast and archive of the event can be
viewed on the "Webcasts & Presentations" page of the
"Investors" section of the Company's website at www.axsome.com.
About AXS-05
AXS-05 is a novel, oral, patent-protected,
investigational NMDA receptor antagonist with multimodal activity
under development for the treatment of major depressive disorder
and other central nervous system (CNS) disorders. AXS-05 consists
of a proprietary formulation and dose of dextromethorphan and
bupropion and utilizes Axsome’s metabolic inhibition technology.
The dextromethorphan component of AXS-05 is a non-competitive
N-methyl-D-aspartate (NMDA) receptor antagonist, also known as a
glutamate receptor modulator, which is a novel mechanism of action,
meaning it works differently than currently approved therapies for
major depressive disorder. The dextromethorphan component of AXS-05
is also a sigma-1 receptor agonist, nicotinic acetylcholine
receptor antagonist, and inhibitor of the serotonin and
norepinephrine transporters. The bupropion component of AXS-05
serves to increase the bioavailability of dextromethorphan, and is
a norepinephrine and dopamine reuptake inhibitor, and a nicotinic
acetylcholine receptor antagonist. AXS-05 is covered by more than
36 issued U.S. and international patents which provide protection
out to 2034. AXS-05 is not approved by the FDA.
About AXS-07
AXS-07 is a novel, oral, investigational
medicine with distinct dual mechanisms of action 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/D 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 AXS-12
AXS-12 (reboxetine) is a novel, oral,
investigational medicine in development for the treatment of the
symptoms of narcolepsy. AXS-12 is a highly selective and potent
norepinephrine reuptake inhibitor. AXS-12 is an investigational
drug product not approved by the FDA.
About Axsome Therapeutics,
Inc.
Axsome Therapeutics, Inc. is a clinical-stage
biopharmaceutical company developing novel therapies for the
management of central nervous system (CNS) disorders for which
there are limited treatment options. Axsome’s core CNS product
candidate portfolio includes four clinical-stage candidates,
AXS-05, AXS-07, AXS-09, and AXS-12. AXS-05 is currently in a Phase
3 trial in treatment resistant depression (TRD), a Phase 3 trial in
major depressive disorder (MDD), and a Phase 2/3 trial in agitation
associated with Alzheimer’s disease (AD). AXS-05 is also being
developed for smoking cessation treatment. AXS-07 is currently in a
Phase 3 trial for the acute treatment of migraine. AXS-12 is
currently in a Phase 2 trial in narcolepsy. AXS-05, AXS-07, AXS-09,
and AXS-12 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 plan to
discontinue the bupropion treatment arm of the ADVANCE-1 study in
accordance with the independent data monitoring committee’s
recommendations); the potential for the ASCEND clinical trial 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 and
the Company’s current expectations regarding its plans for future
equity financings prior to the readout from its Phase 3 trials; 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 Senior Vice
President, Operations Axsome Therapeutics, Inc. 25 Broadway, 9th
Floor New York, NY 10004 Tel: 212-332-3243 Email:
mjacobson@axsome.com www.axsome.com
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