SAGE Sage Therapeutics Inc.

41.22
-0.01  0%
Previous Close 41.23
Open 41.35
52 Week Low 39.77
52 Week High 98.385
Market Cap $2,424,195,644
Shares 58,811,151
Float 43,822,518
Enterprise Value $515,383,075
Volume 222,940
Av. Daily Volume 462,046
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Upcoming Catalysts

Drug Stage Catalyst Date
ZULRESSO (brexanolone)
COVID-19 related acute respiratory distress syndrome (ARDS)
Phase 3
Phase 3
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SAGE-718 - LUMINARY (718-CNA-201)
Alzheimer’s disease (AD) cognitive dysfunction and mild dementia
Phase 2a
Phase 2a
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SAGE-217 - SHORELINE
Major Depressive Disorder (MDD)
Phase 3
Phase 3
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Zuranolone - CORAL (MDD-305)
Major Depressive Disorder
Phase 3
Phase 3
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Zuranolone (SAGE-217) - SKYLARK Study (PPD-301)
Postpartum depression (PPD)
Phase 3
Phase 3
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Zuranolone (SAGE-217) - WATERFALL Study (MDD-301B)
Major depressive disorder (MDD)
NDA Filing
NDA Filing
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Drug Pipeline

Drug Stage Notes
SAGE-718
Huntington's disease
Phase 2
Phase 2
Phase 2 trial to be initiated late 2021.
SAGE-217 - RAINFOREST
Insomnia
Phase 3
Phase 3
Phase 3 enrolment paused 4Q 2020.
SAGE-324
Essential tremor
Phase 2
Phase 2
Phase 2 trial met primary endpoint (P=0.049) - April 12, 2021. 62% of patients were down-titrated to from 60mg to 45 mg or 30 mg with the high dose not well tolerated. Dose-ranging trial to commence late-2021.
SAGE-718 - PARADIGM Study
Parkinson Disease
Phase 2a
Phase 2a
Phase 2a trial was generally well tolerated; there were no serious AEs and no TEAEs.
ZULRESSO (brexanolone) - SAGE-547 (202B)
Postpartum Depression (Severe)
Phase 3
Phase 3
Phase 3 data released November 9, 2017. Primary endpoint met.
ZULRESSO (brexanolone) - SAGE-547 (202C)
Postpartum Depression - moderate
Approved
Approved
FDA approval announced March 19, 2018.
SAGE-217 - MOUNTAIN
Major Depressive Disorder (MDD)
Phase 3
Phase 3
Phase 3 data did not meet primary endpoint - December 5, 2019.
SAGE-217 - ARCHWAY
Bipolar depression
Phase 2
Phase 2
Phase 2 Part A data July 24, 2019 noted MADRS score of 15.5 points at Day 15 (n=23; p<0.0001) - secondary endpoint.
SAGE-217
Postpartum depression (PPD)
Phase 3
Phase 3
Phase 3 data met primary endpoint - January 7, 2019.
SAGE-547
SRSE
Phase 3
Phase 3
Phase 3 data released September 12, 2017 - primary endpoint not met.

Latest News

  1. Sage Therapeutics, Inc. (NASDAQ:SAGE), a biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with debilitating disorders of the brain, today announced it will host a live webcast on Tuesday, November 2, 2021 at 8:00 a.m. ET to announce third quarter 2021 financial results and discuss recent business updates.

    The webcast can be accessed on the investor page of Sage's website at investor.sagerx.com. A replay of the webcast will be available approximately two hours after the completion of the event and will be archived for up to 30 days.

    About Sage Therapeutics

    Sage Therapeutics is a biopharmaceutical company committed to developing novel therapies with the potential to transform…

    Sage Therapeutics, Inc. (NASDAQ:SAGE), a biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with debilitating disorders of the brain, today announced it will host a live webcast on Tuesday, November 2, 2021 at 8:00 a.m. ET to announce third quarter 2021 financial results and discuss recent business updates.

    The webcast can be accessed on the investor page of Sage's website at investor.sagerx.com. A replay of the webcast will be available approximately two hours after the completion of the event and will be archived for up to 30 days.

    About Sage Therapeutics

    Sage Therapeutics is a biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with debilitating disorders of the brain. We are pursuing new pathways with the goal of improving brain health, and our depression, neurology and neuropsychiatry franchise programs aim to change how brain disorders are thought about and treated. Our mission is to make medicines that matter so people can get better, sooner. For more information, please visit www.sagerx.com.

    View Full Article Hide Full Article
  2. Following the pre-NDA meeting, the companies confirmed the current efficacy and safety databases are expected to be adequate for filing with confirmed pathways for MDD and PPD

    The planned initial submission package will be for the treatment of MDD with an anticipated PPD filing thereafter

    Sage Therapeutics, Inc. (NASDAQ:SAGE) and Biogen Inc. (NASDAQ:BIIB) today announced their plan to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for zuranolone, an investigational two-week, once-daily therapeutic in the second half of 2022. The planned initial submission package will seek approval of zuranolone for the treatment of major depressive disorder (MDD) and an additional filing for postpartum depression (PPD…

    Following the pre-NDA meeting, the companies confirmed the current efficacy and safety databases are expected to be adequate for filing with confirmed pathways for MDD and PPD

    The planned initial submission package will be for the treatment of MDD with an anticipated PPD filing thereafter

    Sage Therapeutics, Inc. (NASDAQ:SAGE) and Biogen Inc. (NASDAQ:BIIB) today announced their plan to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for zuranolone, an investigational two-week, once-daily therapeutic in the second half of 2022. The planned initial submission package will seek approval of zuranolone for the treatment of major depressive disorder (MDD) and an additional filing for postpartum depression (PPD) is anticipated in the first half of 2023. The decision to submit the application follows recent discussions with the FDA, including a pre-NDA meeting held this fall. Data from completed studies in the LANDSCAPE and NEST programs, as well as data from the ongoing clinical and pharmacology studies, are planned to be included as part of the submission packages.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211019005298/en/

    "In the pre-NDA meeting, the FDA's response on the regulatory pathway for zuranolone continued to be consistent with previous discussions. In the clinical development programs, zuranolone has shown remarkably consistent, rapid, and sustained reductions in depressive symptoms, including anxiety and sleep loss, in addition to a well-tolerated safety profile. We believe we have a solid filing package with four adequate and well controlled trials now in hand and, if approved, zuranolone will fill a real unmet need and be welcomed by people living with depression," said Barry Greene, Chief Executive Officer at Sage Therapeutics. "We have identified what we believe is the most efficient path forward for an FDA filing and potential approval."

    Sage and Biogen also announced the CORAL Study is fully enrolled and closed to further screening, with topline data expected in early 2022. The CORAL Study is designed to demonstrate a rapid onset of depression relief when zuranolone is co-initiated with a standard antidepressant therapy.

    "We are pleased to share what we believe is an efficient filing pathway for zuranolone, with the goal of bringing a new treatment option to the millions of people who suffer from depression worldwide," said Alfred Sandrock, Jr., M.D., Ph.D., Head of Research and Development at Biogen. "The efficacy and safety data planned for FDA submission support our vision of zuranolone being an as-needed, two-week, once-daily treatment option for MDD and PPD that produces rapid relief from symptoms within days."

    Sage and Biogen plan to submit a separate and distinct filing for PPD once the ongoing PPD 301-SKYLARK Study completes so as not to affect the MDD review timeline. The companies plan to commence marketing for the approved indications as soon as possible pending the FDA's approval. The review cycles may allow commercialization of both indications simultaneously, if approved.

    About Major Depressive Disorder (MDD)

    Major depressive disorder (MDD) is a common but serious mood disorder in which people experience depressive symptoms that impair their social, occupational, educational, or other important functioning, such as a depressed mood or loss of interest or pleasure in daily activities, consistently for at least a two-week period. It is estimated that approximately 19 million people in the U.S. and more than 250 million people worldwide suffer from MDD each year. While antidepressants are widely used to treat MDD, large-scale studies have demonstrated the need for additional therapies with a differentiated profile.

    About Postpartum Depression (PPD)

    Postpartum depression (PPD) is one of the most common medical complications during and after pregnancy. PPD can have a serious negative impact on a woman, including significant functional impairment, depressed mood and/or loss of interest in her newborn, and associated symptoms of depression such as loss of appetite, difficulty sleeping, motor challenges, lack of concentration, loss of energy and poor self-esteem. PPD is estimated to affect approximately one in eight women who have given birth in the U.S. or approximately over 500,000 women annually.

    About Zuranolone

    Zuranolone (SAGE-217/BIIB125) is a once-daily, two-week, investigational drug in development for the treatment of major depressive disorder (MDD) and postpartum depression (PPD). Zuranolone is an investigational oral neuroactive steroid (NAS) GABA-A receptor positive allosteric modulator (PAM). The GABA system is the major inhibitory signaling pathway of the brain and central nervous system and contributes to regulating brain function. Zuranolone has been granted Breakthrough Therapy Designation by the U.S. Food & Drug Administration.

    Zuranolone is being evaluated in the NEST and LANDSCAPE clinical trial programs. The two development programs include multiple studies examining use of zuranolone in several thousand patients with a variety of dosing, clinical endpoints, and treatment paradigms. The LANDSCAPE program includes five studies of zuranolone in patients with MDD (MDD-201B, MOUNTAIN, SHORELINE, WATERFALL, and CORAL Studies). The NEST program includes two placebo-controlled studies of zuranolone in patients with PPD (ROBIN and SKYLARK Studies). Additionally, Shionogi recently completed a Phase 2 study of zuranolone in Japan.

    About Sage Therapeutics

    Sage Therapeutics is a biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with debilitating disorders of the brain. We are pursuing new pathways with the goal of improving brain health, and our depression, neurology and neuropsychiatry franchise programs aim to change how brain disorders are thought about and treated. Our mission is to make medicines that matter so people can get better, sooner. For more information, please visit www.sagerx.com.

    About Biogen

    At Biogen, our mission is clear: we are pioneers in neuroscience. Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. One of the world's first global biotechnology companies, Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Kenneth Murray and Nobel Prize winners Walter Gilbert and Phillip Sharp. Today Biogen has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first approved treatment for spinal muscular atrophy, commercializes biosimilars of advanced biologics and is focused on advancing research programs in multiple sclerosis and neuroimmunology, Alzheimer's disease and dementia, neuromuscular disorders, movement disorders, ophthalmology, neuropsychiatry, immunology, acute neurology and neuropathic pain.

    We routinely post information that may be important to investors on our website at www.biogen.com. Follow us on social media - Twitter, LinkedIn, Facebook, YouTube.

    Forward-Looking Statements

    Sage Therapeutics Safe Harbor

    Various statements in this release concern Sage's future expectations, plans and prospects, including without limitation statements regarding: plans for an NDA filing for zuranolone in MDD and PPD, and the potential timing of such submissions; our belief in the adequacy of the data we plan to submit in the NDA; the potential for FDA acceptance of an NDA for zuranolone; the potential for regulatory approval and commencement of commercialization of zuranolone and our goals as to timing; our planned timing for reporting of data from ongoing clinical trials; the potential profile and benefit of zuranolone in MDD and PPD; our belief in the regulatory filing pathways and opportunities for zuranolone; other planned next steps for the program; our estimates as to the number of patients with MDD and PPD; and other statements regarding the goals, opportunity and potential for zuranolone and for our business. 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: we may experience delays or unexpected hurdles in our efforts to submit an NDA for zuranolone and we may not be able to submit the NDA on the timelines we expect or at all; the FDA may find inadequacies and deficiencies in our NDA for zuranolone, including in the data we submit, and may decide not to accept the NDA for filing; even if the FDA accepts the NDA for filing, the FDA may not meet expected review timelines and may ultimately decide not to approve zuranolone in MDD or PPD; 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; other decisions or actions of the FDA or other regulatory agencies may affect the zuranolone program and our plans, progress or results; we may experience negative results in ongoing or future studies of zuranolone that negatively affect our ability to obtain approval of zuranolone or that impair the potential profile of zuranolone; success in earlier clinical trials 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 or generate results sufficient to gain regulatory approval to market zuranolone without further development work; unexpected concerns may arise from additional data, analysis or results from any of our completed studies; we may encounter adverse results or adverse events at any stage of development that negatively impact further development or that require additional nonclinical and clinical work which may not yield positive results; we may encounter delays in conduct of our clinical trials, including slower than expected site initiation or enrollment, that may impact our ability to meet our expected time-lines; the actual size of the MDD and PPD patient populations may be significantly lower than our estimates and, even if zuranolone is approved, it may only be approved or used to treat a subset of the relevant patient populations; we may encounter technical and other unexpected hurdles in the development and manufacture of zuranolone or our other product candidates which may delay our timing or change our plans; as well as those risks more fully discussed in the section entitled "Risk Factors" in our most recent Quarterly Report on Form 10-Q, 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.

    Biogen Safe Harbor

    This news release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, relating to the potential, benefits, safety and efficacy of zuranolone; the potential clinical effects of zuranolone; the clinical development program for zuranolone; clinical development programs, clinical trials and data readouts and presentations for zuranolone; the potential treatment of MDD and PPD; the potential of Biogen's commercial business and pipeline programs, including zuranolone; the anticipated benefits and potential of Biogen's collaboration arrangement with Sage; and risks and uncertainties associated with drug development and commercialization. These forward-looking statements may be accompanied by words such as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "intend," "may," "plan," "potential," "possible," "will," "would" and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements, or the scientific data presented.

    These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation, uncertainty of success in the development and potential commercialization of zuranolone; unexpected concerns may arise from additional data, analysis or results of clinical studies of zuranolone; regulatory authorities may require additional information or further studies, or may fail or refuse to approve or may delay approval of Biogen's drug candidates, including zuranolone; the occurrence of adverse safety events; the risks of other unexpected hurdles, costs or delays; failure to protect and enforce data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; product liability claims; third party collaboration risks; and the direct and indirect impacts of the ongoing COVID-19 pandemic on our business, results of operations and financial condition. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Biogen's expectations in any forward-looking statement. Investors should consider this cautionary statement as well as the risk factors identified in Biogen's most recent annual or quarterly report and in other reports Biogen has filed with the U.S. Securities and Exchange Commission. These statements are based on Biogen's current beliefs and expectations and speak only as of the date of this news release. Biogen does not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

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  3. Improvement in measurements of overall quality of life, functioning and general well-being achieved at Day 15 and sustained at Day 42

    Consistent and differentiated safety and tolerability profile seen across clinical programs

    Sage to host conference call on October 4, 2021 at 8:00am ET

    Sage Therapeutics, Inc. (NASDAQ:SAGE) and Biogen Inc. (NASDAQ:BIIB) today announced new data from the LANDSCAPE and NEST clinical development programs evaluating the efficacy and safety of zuranolone for the treatment of major depressive disorder (MDD) and postpartum depression (PPD) presented at the 34th European College of Neuropsychopharmacology (ECNP) Congress, taking place October 2-5, 2021. Presentations include data from the WATERFALL Study, a Phase…

    Improvement in measurements of overall quality of life, functioning and general well-being achieved at Day 15 and sustained at Day 42

    Consistent and differentiated safety and tolerability profile seen across clinical programs

    Sage to host conference call on October 4, 2021 at 8:00am ET

    Sage Therapeutics, Inc. (NASDAQ:SAGE) and Biogen Inc. (NASDAQ:BIIB) today announced new data from the LANDSCAPE and NEST clinical development programs evaluating the efficacy and safety of zuranolone for the treatment of major depressive disorder (MDD) and postpartum depression (PPD) presented at the 34th European College of Neuropsychopharmacology (ECNP) Congress, taking place October 2-5, 2021. Presentations include data from the WATERFALL Study, a Phase 3 placebo-controlled trial evaluating the efficacy and safety of zuranolone 50 mg in adults 18 to 64 years old with MDD as well as the open-label SHORELINE Study in MDD and cross-study analyses from across the LANDSCAPE and NEST programs. Collectively, the studies show reductions in depressive symptoms with zuranolone-treated patients such as consistent improvements in depressive mood, as well as rapid onset of significant effect by Day 3. Zuranolone has demonstrated a consistent safety profile in the totality of clinical data to date, with no evidence of withdrawal, weight gain, sexual dysfunction, euphoria, or sleep disruption; symptoms that are typically the cause of treatment discontinuation with current standard of care antidepressants. In pooled analyses from the LANDSCAPE and NEST programs of SF-36v2, a patient self-reported measure of general health, zuranolone treatment led to rapid improvement in quality of life and overall health across all functioning and well-being domains at Day 15 and across all domains at Day 42 (Day 45 in ROBIN Study).

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211004005319/en/

    Additional data presented summarized clinical data from the literature on onset of effect of current treatment options in MDD demonstrating there is a need for new treatment options with the potential for rapid response.

    "The collection of data presented at ECNP showcases the LANDSCAPE and NEST programs, in totality, where we have seen a very consistent and differentiated profile for zuranolone. The efficacy data across the clinical development programs have demonstrated a rapid onset of activity, consistent reductions in depressive symptoms and a two-week treatment regimen that may offer the potential to treat-as-needed. The data also include a robust safety database with more than 3,500 patients treated, showing that zuranolone has been well tolerated to date," said Steve Kanes, M.D., PhD., chief medical officer at Sage Therapeutics. "We believe these data represent the potential for a benefit-risk profile for zuranolone that may be differentiated from the most prescribed depression drugs on the market, and may be welcomed by patients, if approved."

    "The data presented at ECNP further emphasize that zuranolone dosed once daily for two weeks has the potential to produce a rapid reduction of depressive symptoms within days for both major depressive disorder and postpartum depression and a differentiated, well-characterized safety profile," said Katherine Dawson, M.D., head of the Therapeutics Development Unit at Biogen. "Collectively these data represent positive steps in Biogen's journey to expand our footprint in neuropsychiatry and innovate for the millions of people who need new options to address mental health conditions."

    "The efficacy and safety data observed with zuranolone across the LANDSCAPE and NEST clinical programs indicate that, if approved, it may offer the potential for people with MDD and PPD to experience a rapid reduction in their depressive symptoms without side effects such as weight gain, sexual dysfunction and sleep disruption that are often associated with treatments currently on the market," said Anita H. Clayton, M.D., Chair of Psychiatry and Neurobehavioral Sciences, University of Virginia School of Medicine. "Patients in the trials are also indicating through the patient outcome measures that zuranolone helped with their overall well-being."

    Data presented at ECNP:

    • Oral Presentation: Zuranolone in major depressive disorder: topline results from the Phase 3, multicenter, randomized, double-blind, placebo-controlled WATERFALL Study
    • Poster Presentation Title: Zuranolone 30 mg in major depressive disorder: results through 1-year follow-up from the Phase 3, open-label, SHORELINE Study
    • Poster Presentation: Exploring the rapidity of treatment effect for current treatment options for major depressive disorder

    Conference Call Information

    Sage will host a conference call and webcast Monday, October 4, 2021 at 8:00am ET to review the totality of the data presented at ECNP from the zuranolone clinical development programs. Anita Clayton, M.D., Chair of Psychiatry and Neurobehavioral Sciences, University of Virginia School of Medicine will join the conference call to discuss data presented at the ECNP Congress in more detail.

    The live webcast can be accessed on the investor page of Sage's website at investor.sagerx.com. A replay of the webcast will be available on Sage's website approximately two hours after the completion of the event and will be archived for up to 30 days.

    About the Short-Form Health Survey (SF-36)

    The Short Form health survey (SF-36) is an often-used, well-researched, and self-reported measure of general health. The SF-36 uses 36 questions, covering eight domains of health, to assess the general health status and quality of life at the individual level in clinical practice and research, and at the population level for health policy evaluations. The SF-36 has been used in thousands of research studies, and while it was originally designed as a generic health measure, it is also applied to specific disease populations. The SF-36 represents an international benchmark for health outcomes measurement and has been used as efficacy endpoints in clinical trials.

    About Major Depressive Disorder (MDD)

    Major depressive disorder (MDD) is a common but serious mood disorder in which people experience depressive symptoms that impair their social, occupational, educational, or other important functioning, such as a depressed mood or loss of interest or pleasure in daily activities, consistently for at least a two-week period. It is estimated that approximately 19 million people in the U.S. and more than 250 million people worldwide suffer from MDD each year. While antidepressants are widely used to treat MDD, large-scale studies have demonstrated the need for additional therapies with a differentiated profile.

    About Zuranolone

    Zuranolone (SAGE-217/BIIB125) is a once-daily, two-week, investigational drug in development for the treatment of major depressive disorder (MDD) and postpartum depression (PPD). Zuranolone is an investigational oral neuroactive steroid (NAS) GABA-A receptor positive allosteric modulator (PAM). The GABA system is the major inhibitory signaling pathway of the brain and central nervous system and contributes to regulating brain function. Zuranolone has been granted Breakthrough Therapy Designation by the U.S. Food & Drug Administration.

    Zuranolone is being evaluated as a potential rapid-acting treatment for PPD and MDD in the NEST and LANDSCAPE clinical trial programs. The two development programs include multiple studies examining use of zuranolone in several thousand patients with a variety of dosing, clinical endpoints, and treatment paradigms. The LANDSCAPE program includes five studies of zuranolone in patients with MDD. Data have been reported from three studies of zuranolone 30 mg in patients with MDD (MDD-201B, MOUNTAIN Study and the 30 mg cohort from the ongoing SHORELINE Study), and one study of zuranolone 50 mg in patients with MDD (WATERFALL Study) in addition to an interim cut of the zuranolone 50mg cohort of the ongoing SHORELINE Study. Two additional studies evaluating zuranolone 50 mg in patients with MDD are expected to read out by the end of 2021 (CORAL Study and another cut of the 50mg cohort of the SHORELINE Study).

    The NEST Program includes two placebo-controlled studies of zuranolone in patients with PPD. Positive data from the ROBIN Study (zuranolone 30 mg) have been previously reported. The SKYLARK Study (zuranolone 50 mg) is anticipated to readout by mid-2022.

    The programs are designed to generate data to support a potential NDA filing as efficiently as possible. If successful, LANDSCAPE and NEST may support paths to approval with three distinct opportunities to address patient needs: PPD, acute rapid response therapy in MDD when co-initiated with a new standard antidepressant, and as-needed treatment of MDD.

    About Sage Therapeutics

    Sage Therapeutics is a biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with debilitating disorders of the brain. We are pursuing new pathways with the goal of improving brain health, and our depression, neurology and neuropsychiatry franchise programs aim to change how brain disorders are thought about and treated. Our mission is to make medicines that matter so people can get better, sooner. For more information, please visit www.sagerx.com.

    About Biogen

    At Biogen, our mission is clear: we are pioneers in neuroscience. Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. One of the world's first global biotechnology companies, Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Kenneth Murray and Nobel Prize winners Walter Gilbert and Phillip Sharp. Today Biogen has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first approved treatment for spinal muscular atrophy, commercializes biosimilars of advanced biologics and is focused on advancing research programs in multiple sclerosis and neuroimmunology, Alzheimer's disease and dementia, neuromuscular disorders, movement disorders, ophthalmology, neuropsychiatry, immunology, acute neurology and neuropathic pain.

    We routinely post information that may be important to investors on our website at www.biogen.com. Follow us on social media - Twitter, LinkedIn, Facebook, YouTube.

    Forward-Looking Statements

    Sage Therapeutics Safe Harbor

    Various statements in this release concern Sage's future expectations, plans and prospects, including without limitation statements regarding: the potential for future regulatory approval of zuranolone; our planned timing for reporting of data from ongoing clinical trials; the potential profile and benefit of zuranolone in MDD and PPD; regulatory filing plans and potential pathways and opportunities; planned next steps for the program; our estimates as to the number of patients with MDD; and the goals, opportunity and potential for zuranolone and for our business. 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: success in earlier clinical trials 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 or generate results sufficient to file for or gain regulatory approval to market a product without further development work; unexpected concerns may arise from additional data, analysis or results from any of our completed studies; we may encounter adverse results or adverse events at any stage of development that negatively impact further development or that require additional nonclinical and clinical work which may not yield positive results; we may encounter delays in conduct of our clinical trials, including slower than expected site initiation or enrollment, that may impact our ability to meet our expected time-lines; the FDA may ultimately decide that the design, conduct or results of our completed, ongoing and planned clinical trials for zuranolone, even if positive, are not sufficient for regulatory filing or approval in the indications that are the focus of our development plan and may require additional trials or data which may significantly delay our efforts to obtain approval and may not be successful; other decisions or actions of the FDA or other regulatory agencies may affect the zuranolone program and our plans, progress or results; the actual size of the MDD patient population may be significantly lower than our estimates and, even if zuranolone is approved, it may only be approved or used to treat a subset of the relevant patient populations; we may encounter technical and other unexpected hurdles in the development and manufacture of zuranolone or our other product candidates which may delay our timing or change our plans; as well as those risks more fully discussed in the section entitled "Risk Factors" in our most recent Quarterly Report on Form 10-Q, 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.

    Biogen Safe Harbor

    This news release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, relating to the potential, benefits, safety and efficacy of zuranolone; the potential clinical effects of zuranolone; results from the WATERFALL and SHORELINE Studies of zuranolone; the clinical development program for zuranolone; clinical development programs, clinical trials and data readouts and presentations for zuranolone; the potential treatment of MDD and PPD; the potential of Biogen's commercial business and pipeline programs, including zuranolone; the anticipated benefits and potential of Biogen's collaboration arrangement with Sage; and risks and uncertainties associated with drug development and commercialization. These forward-looking statements may be accompanied by words such as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "intend," "may," "plan," "potential," "possible," "will," "would" and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements, or the scientific data presented.

    These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation, uncertainty of success in the development and potential commercialization of zuranolone; unexpected concerns may arise from additional data, analysis or results obtained during the WATERFALL and SHORELINE Studies or the other clinical studies of zuranolone; regulatory authorities may require additional information or further studies, or may fail or refuse to approve or may delay approval of Biogen's drug candidates, including zuranolone; the occurrence of adverse safety events; the risks of other unexpected hurdles, costs or delays; failure to protect and enforce data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; product liability claims; third party collaboration risks; and the direct and indirect impacts of the ongoing COVID-19 pandemic on our business, results of operations and financial condition. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Biogen's expectations in any forward-looking statement. Investors should consider this cautionary statement as well as the risk factors identified in Biogen's most recent annual or quarterly report and in other reports Biogen has filed with the U.S. Securities and Exchange Commission. These statements are based on Biogen's current beliefs and expectations and speak only as of the date of this news release. Biogen does not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

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  4. Effort embodies Sage's long-term commitment to investing in People, Patients, Planet and Community

    Sage Therapeutics (NASDAQ:SAGE), a biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with debilitating disorders of the brain, today announced the launch of SageCitizen – a corporate social impact effort that activates and amplifies Sage's long-term commitment to People, Patients, Planet and Community.

    "At the core of our work at Sage is our mission to transform the lives of people with brain health disorders. We see the potential positive impact we can have on individuals, families and society not just with the novel treatments that we are developing, but with our engagement…

    Effort embodies Sage's long-term commitment to investing in People, Patients, Planet and Community

    Sage Therapeutics (NASDAQ:SAGE), a biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with debilitating disorders of the brain, today announced the launch of SageCitizen – a corporate social impact effort that activates and amplifies Sage's long-term commitment to People, Patients, Planet and Community.

    "At the core of our work at Sage is our mission to transform the lives of people with brain health disorders. We see the potential positive impact we can have on individuals, families and society not just with the novel treatments that we are developing, but with our engagement in the communities where we live and work," said Barry Greene, Chief Executive Officer at Sage Therapeutics. "In the context of the current brain health pandemic, the launch of SageCitizen solidifies our deep, long-term relationships with community partners in a strategic and holistic way that aligns with our goal of making a meaningful and sustained contribution to people and society."

    SageCitizen launched with more than 200 Sage employee volunteers participating in a week of service comprised of virtual and in-person activities, including:

    • Packing Emergency Aid duffle bags with longtime partner Wonderfund, a private, non-profit organization that works on behalf of children engaged with the Massachusetts Department of Children and Families. Sage volunteers assembled close to 500 bags with new clothing and essential items for children who experience emergency home removals due to abuse and neglect.
    • Building beds with Boston Cares, New England's largest volunteer agency, Sage volunteers worked in teams to sand, assemble, and paint twin bed frames for homeless children, providing them access to their own beds when transitioning from shelters to new residencies through the Massachusetts Coalition for the Homeless – A Bed for Every Child Initiative.
    • Packaging a one-month supply of menstrual products with Dignity Matters, a non-profit organization that collects, purchases, and supplies feminine hygiene products and undergarments to low-income and homeless women and girls in the Boston area. The packages will help them stay healthy, regain self-confidence, and live with basic dignity. Sage employees also wrote letters of support and affirmation to recipients of the hygiene packages.

    SageCitizen formalizes Sage's social impact efforts, further strengthening the social impact of the philanthropic and community activities Sage and its employees have been involved in since 2014. SageCitizen is organized around four pillars:

    • People – Sage is committed to providing employees a meaningful career journey and an inclusive culture where they can do their best work, while channeling their passion for helping others with opportunities to make a difference and improve lives. Sage celebrates people for who they are through a culture of respect and belonging that welcomes fresh thinking and unique perspectives. The company's holistic well-being benefits and SageFlex work model support Sage employees to live life to its fullest, whether in the office, their homes, or their communities.
    • Patients – Partnering with and learning from diverse patient organizations is core to Sage's mission to make medicines that matter so people can get better sooner. These groups serve a vital role as independent patient champions and agents of change in pursuit of several shared goals: reducing stigma, improving patient care, and enhancing access to medicines and services for people impacted by brain health disorders.
    • Planet – Recognizing that no one company can solve the planet's problems alone, Sage is committed to doing its part to reduce its carbon footprint and make the earth a healthier place to live. Sage provides green transportation incentives, reduces its waste stream by composting, recycling and eliminating plastic, and educates Sage employees about how to integrate green best practices at home.​​​​​​​
    • Community – Sage engages with organizations supporting families, children and individuals who are facing hardship or social isolation that can lead to depression. Sage's community philanthropy focus areas are essential service organizations that supplement daily necessities from food to clothing to temporary shelter; and social connection programs that increase connectivity for those separated from loved ones, letting them know they are not alone and that someone cares.

    Through SageCitizen, Sage seeks to deepen relationships with its partners by developing more long-term engagement opportunities that are intended to increase impact on the well-being of Sage's people, patients, planet, and communities where they work and live.

    "Putting people first is part of everything we do at Sage – from how we engage and treat patients and their families, to the respect and compassion we have for each other, our community and our planet," said Erin Lanciani, Chief People & Experience Officer, Sage Therapeutics. "We are thrilled to formalize these efforts as we launch SageCitizen."

    About Sage Therapeutics

    Sage Therapeutics is a biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with debilitating disorders of the brain. We are pursuing new pathways with the goal of improving brain health and our depression, neurology and neuropsychiatry franchise programs aim to change how brain disorders are thought about and treated. Our mission is to make medicines that matter so people can get better, sooner. For more information, please visit www.sagerx.com.

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  5. Sage Therapeutics (NASDAQ:SAGE), a biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with debilitating disorders of the brain, today announced the appointment of Chris Benecchi as Chief Commercial Officer. In his new role, Mr. Benecchi will lead Sage's global commercial efforts across all Sage programs, new product planning, strategy, and competitive intelligence.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210921005386/en/

    Chris Benecchi, Chief Commercial Officer, Sage Therapeutics (Photo: Business Wire)

    Chris Benecchi, Chief Commercial Officer, Sage Therapeutics (Photo: Business Wire)

    "Chris Benecchi is an innovator, a transformative global commercial leader and a strategic launch expert…

    Sage Therapeutics (NASDAQ:SAGE), a biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with debilitating disorders of the brain, today announced the appointment of Chris Benecchi as Chief Commercial Officer. In his new role, Mr. Benecchi will lead Sage's global commercial efforts across all Sage programs, new product planning, strategy, and competitive intelligence.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210921005386/en/

    Chris Benecchi, Chief Commercial Officer, Sage Therapeutics (Photo: Business Wire)

    Chris Benecchi, Chief Commercial Officer, Sage Therapeutics (Photo: Business Wire)

    "Chris Benecchi is an innovator, a transformative global commercial leader and a strategic launch expert," said Barry Greene, Chief Executive Officer at Sage Therapeutics. "He has a track record of designing winning commercial strategies and launching novel therapies that have sustained long-term growth in highly competitive markets. I am confident that Chris will provide the vision, leadership and strategic thinking needed to drive the commercialization efforts across Sage's portfolio and with our partners as we continue on our mission to successfully build a top tier biopharmaceutical company."

    As a highly engaged, cross-functional leader, Mr. Benecchi will work in collaboration with internal partners to create a shared, mission-driven, launch vision that reflects the input we receive from external stakeholders. Among his responsibilities will be to ensure smooth working relationships with Sage's partners and an integrated commercialization plan for zuranolone – a once-daily, two-week therapy in Phase 3 clinical development for the treatment of major depressive disorder (MDD) and postpartum depression (PPD). Mr. Benecchi will also lead commercialization strategies across the company's leading portfolio of treatments for brain health disorders.

    "With a robust pipeline of differentiated products being studied for their potential to improve brain health, it is an exciting time to join Sage and help execute plans to accelerate development of innovative treatments on a global level with a potential impact, if we are successful, on several hundred million people around the world," said Chris Benecchi. "It is an honor to join Sage's world-class team at such a pivotal moment in the advancement of multiple programs across the company's depression, neurology, and neuropsychiatric franchises."

    Chris Benecchi joins Sage from Alexion, where he served as Vice President, Global Head of Commercial Excellence. Previously, he spent eight years at UCB in commercial roles of increasing responsibility including Global Launch Head, Commercial and Medical Affairs, Immunology and Global Commercial Strategy Lead, Immunology. He began his career in sales at J&J and held sales leadership and senior marketing roles at Takeda as well. Mr. Benecchi received an MBA from Duke University and a BA from Colby College.

    About Sage Therapeutics

    Sage Therapeutics is a biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with debilitating disorders of the brain. We are pursuing new pathways with the goal of improving brain health and our depression, neurology and neuropsychiatry franchise programs aim to change how brain disorders are thought about and treated. Our mission is to make medicines that matter so people can get better, sooner. For more information, please visit www.sagerx.com.

    Forward-Looking Statements

    Various statements in this release concern Sage's future expectations, plans and prospects, including without limitation, our views and expectations regarding: the potential success of our development-stage products; the potential for future launch and commercialization of any such products, if successfully developed; the potential profile and benefit of the products we are developing; the number of people who may benefit from our products, if successfully developed and approved; the mission, vision, strategies, plans and goals for our business; and the potential for 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: we may not successfully complete development of any of our current or future product candidates in any indication we are currently pursuing or may in the future pursue; success in non-clinical studies or in earlier clinical trials or at interim time periods may not be repeated or observed in ongoing or future studies, and ongoing and future non-clinical and clinical results may not meet their primary or key secondary endpoints; the results of completed, ongoing and future studies may not be sufficient to file for or gain regulatory approval to market a product without further development work; unexpected concerns may arise from additional data, analysis or results from any of our completed studies; we may encounter adverse events at any stage that negatively impact further development, our ability to seek or obtain regulatory approval or commercialization of such product; we may encounter delays in initiation, conduct or completion of our ongoing and planned clinical trials; the FDA and other regulatory agencies may ultimately decide that the design or results of our completed, ongoing and planned clinical trials, even if positive, are not sufficient to file for or obtain regulatory approval in the indications that are the focus of our development plans even if we have had prior discussions with the agency supporting our approach; other decisions or actions of the FDA or other regulatory agencies may affect the initiation, timing, design, size, and progress of clinical trials and our ability to proceed with further development or our ability to obtain approval; even if we obtain regulatory approval of a new product, our launch efforts may not be successful and we may never be able to generate meaningful revenues from sales of such product at levels we expect or at levels necessary to justify our investment; the number of patients with the diseases or disorders for which our products are developed, the unmet need for additional treatment options and the potential market for our current or future products may be significantly smaller than we expect; and we may encounter technical and other unexpected hurdles in the development or manufacture of our product candidates or the manufacture, distribution or commercialization of our marketed product which may delay our timing or change our plans or otherwise negatively impact our business; as well as those risks more fully discussed in the section entitled "Risk Factors" in our most recent Quarterly Report on Form 10-Q, 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.

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