Robust pipeline provides potential for
long-term value creation, establishing Sage as a leader in brain
health
Rolling New Drug Application (NDA) submission
for zuranolone in MDD and PPD complete, with potential for PDUFA
date as early as the third quarter of 2023 if priority review is
received and other timelines meet expectations
Progressing nine ongoing studies across
zuranolone, SAGE-718, SAGE-324 and early pipeline programs
Sage Therapeutics, Inc. (Nasdaq: SAGE), a biopharmaceutical
company leading the way to create a world with better brain health,
today announced that Chief Executive Officer, Barry Greene, will
discuss the Company’s progress in developing a leading brain health
pipeline at the 41st Annual J.P. Morgan Healthcare Conference in
San Francisco, California.
As part of this presentation, Mr. Greene will provide key
updates on programs across Sage’s depression, neuropsychiatry and
neurology portfolios. Sage is advancing a portfolio of clinical
programs featuring internally discovered novel chemical entities
with the potential to become differentiated products designed to
improve brain health by targeting the GABAA and NMDA receptor
systems. Dysfunction in these systems is thought to be at the core
of numerous neurological and neuropsychiatric disorders.
“It’s time to begin a new era in the treatment of brain health
disorders. We at Sage have a tremendous sense of urgency to create
innovative medicines that address what matters most for people who
currently lack adequate treatment options,” said Barry Greene,
Chief Executive Officer at Sage Therapeutics. “We enter 2023 having
completed the submission of the rolling NDA for zuranolone in the
treatment of major depressive disorder and postpartum depression
with our collaborator Biogen. We’ve also made progress in
initiating multiple studies across our pipeline, including SAGE-718
and SAGE-324. We believe that this momentum will help us achieve
our mission to improve the lives of millions of people and advance
the way brain health is viewed and treated.”
Sage and its collaborator Biogen recently announced the
submission of the zuranolone New Drug Application to the FDA for
the treatment of major depressive disorder (MDD) and postpartum
depression (PPD). Zuranolone, Sage’s next-generation positive
allosteric modulator (PAM) of GABAA receptors, is being evaluated
as a potential rapid-acting treatment for MDD and PPD. If approved,
zuranolone could represent the first oral, short course (14-day)
medication for these indications. In the clinical development
program to date, zuranolone has shown rapid and sustained
improvement of depressive symptoms with a generally well-tolerated
and consistent safety profile.
Sage and Biogen are focused on preparing for a potential launch
of zuranolone for both MDD and PPD in 2023, if approved, with the
ultimate goal of transforming the way depression is treated.
Current efforts are focused on disease state education in MDD and
PPD, scientific exchange and permitted interactions with payers.
Sage expects these efforts and other permitted pre-launch
activities to continue to broaden and ramp up in the coming
year.
Sage continues to advance a robust clinical program for
SAGE-718, the Company’s first-in-class NMDA receptor PAM and lead
neuropsychiatric drug candidate. SAGE-718 is in development as a
potential oral therapy for cognitive disorders associated with NMDA
receptor dysfunction, with multiple ongoing or planned Phase 2
studies across multiple disease areas, including its potential lead
indication, Huntington’s disease (HD), as well as Alzheimer’s (AD)
and Parkinson’s diseases (PD). The company recently initiated
LIGHTWAVE (CNA-202), a Phase 2 study of SAGE-718 in people with
mild cognitive impairment and mild dementia due to AD and PURVIEW
(CIH-301), a Phase 3 extension study in people with HD.
“We are proud of the progress we’ve made in advancing the
SAGE-718 development program as we work to address impaired
cognition, a main driver of disability in the indications we are
studying, including Huntington’s, Alzheimer’s and Parkinson’s
diseases,” said Laura Gault, M.D., Ph.D., Chief Medical Officer at
Sage. “Our goal with SAGE-718 is to provide rapid, meaningful, and
sustained symptomatic improvement in cognitive function early in
disease so that patients can maintain independence longer.”
Anticipated 2023 Key
Milestones
The Company anticipates the following key milestones in
2023:
- Zuranolone:
- Early:
- FDA acceptance of rolling NDA submission for zuranolone in MDD
and PPD
- Mid:
- Present additional data from the SHORELINE Study
- Late:
- PDUFA date for zuranolone in MDD and PPD, if accepted for
review by the FDA
- Commercial availability of zuranolone in MDD and PPD, if
priority review is granted and zuranolone is approved
- Initiate a lifecycle innovation study with zuranolone
- Present additional analyses of data from LANDSCAPE and NEST
clinical programs, including health economics and patient reported
outcomes
- SAGE-718:
- Progress recruitment in the ongoing DIMENSION, SURVEYOR,
PURVIEW, PRECEDENT, and LIGHTWAVE Studies
- Present additional analyses of data from clinical development
program as well as disease state and burden of disease research in
Huntington's, Parkinson’s and Alzheimer’s diseases
- SAGE-324:
- Late:
- Complete enrollment in the Phase 2b KINETIC 2 Study
- Present additional analyses of data from clinical development
program as well as disease state and burden of disease research in
ET
About Sage Therapeutics
Sage Therapeutics is a biopharmaceutical company fearlessly
leading the way to create a world with better brain health. Our
mission is to pioneer solutions to deliver life-changing brain
health medicines, so every person can thrive. For more information,
please visit http://www.sagerx.com.
Forward-Looking Statements
Various statements in this release concern Sage's future
expectations, plans and prospects, including without limitation our
statements regarding: the potential for our NDA for zuranolone in
MDD and PPD to be accepted and the possibility of priority review;
the potential for approval and launch of zuranolone and potential
timelines; our belief in the potential benefit and profile of
zuranolone and in its potential to be successful and to meet an
unmet need in the treatment of MDD and PPD; the potential for
commercialization of zuranolone and our commercialization strategy
and plans, including plans to help enable access; our expectations
as to the types of MDD patients who may benefit from zuranolone, if
approved; other planned activities and next steps for the
zuranolone program; anticipated timelines for commencement of
trials, completion of dosing, initiation of new activities and
other plans for our other programs and early stage pipeline; our
belief in the potential profile and benefit of our product
candidates; potential indications for our product candidates; the
potential for success of our programs, and the opportunity to help
patients in various indications; the number of patients with the
indications we are pursuing or may in the future pursue and the
unmet need; and the mission and goals for our business and
potential for long-term value creation.
These statements constitute forward-looking statements as that
term is defined in the Private Securities Litigation Reform Act of
1995. These forward-looking statements are neither promises nor
guarantees of future performance, and are subject to a variety of
risks and uncertainties, many of which are beyond our control,
which could cause actual results to differ materially from those
contemplated in these forward-looking statements, including the
risks that: the FDA may find inadequacies and deficiencies in our
NDA for zuranolone, including in the data we submit, despite prior
discussions, and may decide not to accept the NDA for filing; even
if the FDA accepts the NDA for filing, the FDA may find that the
data included in the NDA are not sufficient for approval and may
not approve the NDA in MDD or PPD, or both; the FDA may decide that
the design, conduct or results of our completed and ongoing
clinical trials for zuranolone, even if positive, are not
sufficient for approval in MDD or PPD and may require additional
trials or data which may significantly delay and put at risk our
efforts to obtain approval and may not be successful; even if our
NDA is successfully filed and accepted, the FDA may not grant
priority review or meet expected review timelines for our NDA which
would delay our launch timelines if zuranolone is approved; other
decisions or actions of the FDA may affect our efforts with respect
to zuranolone and our plans, progress, results and expected
timelines; our expectations for timing of review of our NDA and of
launch of zuranolone, if approved, may not be accurate; results of
ongoing or future studies may impact our ability to obtain approval
of zuranolone or impair the potential profile of zuranolone;
success in earlier clinical trials of any of our other product
candidates may not be repeated or observed in ongoing or future
studies, and ongoing and future clinical trials may not meet their
primary or key secondary endpoints which may substantially impair
development; unexpected concerns may arise from additional data,
analysis or results from any of our completed studies; we may
encounter adverse events at any stage for any of product candidates
that negatively impact further development, the potential for
approval or the potential for successful commercialization or that
require additional nonclinical and clinical work which may not
yield positive results; we may encounter delays in initiation,
conduct, completion of enrollment or completion of our ongoing and
planned clinical trials, including as a result of slower than
expected site initiation, slower than expected enrollment, the need
or decision to expand the trials or other changes, that may impact
our ability to meet our expected timelines and increase our costs;
decisions or actions of the FDA or other regulatory agencies may
affect the initiation, timing, design, size, progress and cost of
clinical trials and our ability to proceed with further development
or may impair the potential for successful development; we may not
be successful in our efforts to gain regulatory approval of any
products, even if successfully developed and approved; we may not
achieve revenues from any future products, including zuranolone, if
approved, at the levels we expect; the number of patients with the
diseases or disorders for which our product candidates are being
developed, the unmet need for additional treatment options and the
potential use cases and market for our current or future products,
including zuranolone, if approved, may be significantly smaller
than we expect; zuranolone, if approved, or any of our other
products that may be approved in the future, may not have the
profile we expect in clinical practice after launch or may not
achieve market acceptance for other reasons or we may encounter
reimbursement-related or other market-related issues that impact
the success of our commercialization efforts; the anticipated
benefits of our ongoing collaborations, including the achievement
of events tied to milestone payments or the successful development
or commercialization of products and generation of revenue, may
never be achieved; the need to align with our collaborators may
hamper or delay our development and commercialization efforts or
increase our costs; our business may be adversely affected and our
costs may increase if any of our key collaborators fails to perform
its obligations or terminates our collaboration; the internal and
external costs required for our ongoing and planned activities, and
the resulting impact on expense and use of cash, may be higher than
expected which may cause us to use cash more quickly than we expect
or change or curtail some of our plans or both; we may never be
able to generate meaningful revenues from sales of our marketed
product or to generate revenues at levels we expect or at levels
necessary to justify our investment; our expectations as to
sufficiency of cash to fund future operations and expense levels
may prove not to be correct for these and other reasons such as
changes in plans or actual events being different than our
assumptions; we may be opportunistic in our future financing plans
even if available cash is sufficient; additional funding may not be
available on acceptable terms when we need it; and we may encounter
technical and other unexpected hurdles in the development and
manufacture of our product candidates or the commercialization of
any marketed product which may delay our timing or change our
plans, increase our costs or otherwise negatively impact our
business; any of the foregoing or other issues may negatively
impact our value creation opportunity, as well as those risks more
fully discussed in the section entitled "Risk Factors" in our most
recent quarterly report, as well as discussions of potential risks,
uncertainties, and other important factors in our subsequent
filings with the Securities and Exchange Commission. In addition,
any forward-looking statements represent our views only as of
today, and should not be relied upon as representing our views as
of any subsequent date. We explicitly disclaim any obligation to
update any forward-looking statements.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230108005038/en/
Investor Contact Helen Rubinstein 315-382-3979
helen.rubinstein@sagerx.com
Media Contact Matthew Henson 917-930-7147
matthew.henson@sagerx.com
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