SAGE Sage Therapeutics Inc.

69.86
+1.29  (+2%)
Previous Close 68.57
Open 68.11
52 Week Low 25.01
52 Week High 153.38
Market Cap $3,635,840,157
Shares 52,044,663
Float 37,691,419
Enterprise Value $3,141,676,320
Volume 1,291,422
Av. Daily Volume 652,531
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Upcoming Catalysts

Drug Stage Catalyst Date
PARADIGM Study (718-CNP-201)
Parkinson Disease
Phase 2a
Phase 2a
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SAGE-324
Essential tremor
Phase 2
Phase 2
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Zuranolone (SAGE-217) - WATERFALL Study (MDD-301B)
Major depressive disorder (MDD)
Phase 3
Phase 3
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Brexanolone
COVID-19 related acute respiratory distress syndrome (ARDS)
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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Drug Pipeline

Drug Stage Notes
SAGE-718
Huntington's disease
Phase 2a
Phase 2a
Phase 2a trial planned for 4Q 2020.
SAGE-217 - SHORELINE
Major Depressive Disorder (MDD)
Phase 3
Phase 3
Phase 3 interim data released October 15, 2020.
SAGE-217 - REDWOOD
Major Depressive Disorder
Phase 3
Phase 3
Phase 3 enrolment paused 4Q 2019.
SAGE-217 - RAINFOREST
Insomnia
Phase 3
Phase 3
Phase 3 enrolment paused 4Q 2020.
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.
Brexanolone - SAGE-547 (202C)
Postpartum Depression - moderate
Approved
Approved
FDA approval announced March 19, 2018.
SAGE-217
Postpartum depression (PPD)
Phase 3
Phase 3
Phase 3 data met primary endpoint - January 7, 2019.
Brexanolone - SAGE-547 (202B)
Postpartum Depression (Severe)
Phase 3
Phase 3
Phase 3 data released November 9, 2017. Primary endpoint met.
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 that the Company will present at the BMO 2020 Growth & ESG Conference on Wednesday, December 9, 2020 at 3:00 p.m. ET.

    A live webcast of the presentation can be accessed on the investor page of Sage's website at investor.sagerx.com. A replay of the webcast will also be archived for up to 30 days on Sage's website following the conference.

    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…

    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 that the Company will present at the BMO 2020 Growth & ESG Conference on Wednesday, December 9, 2020 at 3:00 p.m. ET.

    A live webcast of the presentation can be accessed on the investor page of Sage's website at investor.sagerx.com. A replay of the webcast will also be archived for up to 30 days on Sage's website following the conference.

    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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    • Biogen and Sage enter into an agreement to jointly develop and commercialize zuranolone and SAGE-324 in the U.S.
    • Biogen to receive exclusive license to develop and commercialize zuranolone and SAGE-324 outside of the U.S., excluding rights to zuranolone in Japan, Taiwan and South Korea
    • Sage Therapeutics to receive $1.525 billion in cash comprised of an upfront payment of $875 million and a $650 million equity investment as well as potential milestone payments, profit sharing and royalties
    • Sage to host conference call Monday, November 30 at 8:00 a.m. ET
    • Biogen to host conference call Monday, November 30 at 9:00 a.m. ET

    CAMBRIDGE, Mass., Nov. 27, 2020 (GLOBE NEWSWIRE) -- Biogen Inc. (NASDAQ:BIIB) and Sage Therapeutics, Inc. (NASDAQ:SAGE) announced…

    • Biogen and Sage enter into an agreement to jointly develop and commercialize zuranolone and SAGE-324 in the U.S.

    • Biogen to receive exclusive license to develop and commercialize zuranolone and SAGE-324 outside of the U.S., excluding rights to zuranolone in Japan, Taiwan and South Korea
    • Sage Therapeutics to receive $1.525 billion in cash comprised of an upfront payment of $875 million and a $650 million equity investment as well as potential milestone payments, profit sharing and royalties
    • Sage to host conference call Monday, November 30 at 8:00 a.m. ET
    • Biogen to host conference call Monday, November 30 at 9:00 a.m. ET

    CAMBRIDGE, Mass., Nov. 27, 2020 (GLOBE NEWSWIRE) -- Biogen Inc. (NASDAQ:BIIB) and Sage Therapeutics, Inc. (NASDAQ:SAGE) announced that they have executed a global collaboration and license agreement to jointly develop and commercialize zuranolone (SAGE-217) for major depressive disorder (MDD), postpartum depression (PPD) and other psychiatric disorders and SAGE-324 for essential tremor and other neurological disorders.

    "We are excited about the potential to bring together Biogen's leading capabilities in neuroscience with Sage's deep expertise in psychiatry," said Michel Vounatsos, Biogen's Chief Executive Officer. "Major depressive disorder affects approximately 17 million people in the U.S. alone, and is a common co-morbidity of multiple neurological disorders in Biogen's core therapeutic areas. There is a tremendous unmet medical need in depression, and we are optimistic about the potential for zuranolone to help transform the treatment of depression and address the stigma often associated with chronic use of antidepressants."

    "With the recent and pending data outputs for zuranolone and SAGE-324, the timing is right for a collaboration between two like-minded companies committed to patients and driven by a passion for neuroscience and brain health," said Mike Cloonan, Chief Operating Officer at Sage Therapeutics. "Through this collaboration, Sage and Biogen have the potential to build something greater together than either could have done alone. We will leverage each other's existing expertise while continuing to build new capabilities in our efforts to create paradigm shifts in the treatment of depression, PPD and essential tremor -- disorders that have gone too long with few treatment innovations. Additionally, the cash from the collaboration is expected to enable Sage to accelerate and expand value potential for its pipeline and will enhance Sage's strategic, financial and operational flexibility as well as strengthening our multi-franchise approach."

    Zuranolone, a potential first-in-class, two-week, once-daily oral therapy in development for the treatment of MDD and PPD, is currently in Phase 3 development as part of the LANDSCAPE and NEST clinical programs. Zuranolone has breakthrough therapy designation from the U.S. Food and Drug Administration (FDA) for MDD and, if successfully developed and approved, has the potential to be a novel treatment paradigm in depression.

    The vision for zuranolone in MDD and PPD is based on its potential, being evaluated in the LANDSCAPE and NEST development programs, to work rapidly and to continue providing sustained benefit beyond the period of dosing. Together, these two features, if supported by positive clinical efficacy and safety data, could provide an alternative option to how depression is treated today based on a target profile of an "as-needed" short course of treatment for a depressive episode, with rapid and sustained efficacy and favorable tolerability. The development of an "as-needed" treatment for depression may help ease the difficulties associated with chronic use of antidepressants and may enhance quality of life and patient adherence.

    An estimated 17 million Americans experience symptoms of MDD each year. Additionally, a September 2020 Journal of the American Medical Association article found that, in the U.S., depression symptoms are more than three times higher during the COVID-19 pandemic than before. MDD is one of the largest contributors to disability in the U.S. and worldwide.

    Postpartum depression is a major depressive episode that can occur during pregnancy or postpartum and is one of the most common medical complications during and after pregnancy. In the U.S., an estimated 1 in 8 mothers experience symptoms of PPD which equates to approximately 500,000 annual cases.

    If approved, zuranolone would also be highly complementary to several of Biogen's therapeutic areas of focus, including multiple sclerosis (MS), Alzheimer's disease (AD), spinal muscular atrophy (SMA), amyotrophic lateral sclerosis (ALS) and Parkinson's disease (PD). Depression is a common co-morbidity in patients with these neurological disorders and their caregivers. Biogen estimates that ~ 50 percent of patients with MS, ~ 40 percent of patients with AD, ~ 50 percent of patients with PD, ~ 30 percent of patients with ALS and ~ 60 percent of SMA caregivers experience depression. In addition, many patients with AD see psychiatrists as part of their diagnostic and/or treatment journey.

    Zuranolone is a next-generation positive allosteric modulator of the gamma-aminobutyric acid (GABAA) receptor. The GABAA system is the major inhibitory signaling pathway of the brain and central nervous system (CNS), and contributes significantly to regulating CNS function. This mechanism of action is a novel approach that may enable a new class of antidepressants.

    To date, two positive pivotal studies have been completed with zuranolone 30 mg, one in MDD (MDD-201) and one in PPD (ROBIN Study). Additionally, while the Phase 3 MOUNTAIN Study of zuranolone in MDD did not meet its primary endpoint, the encouraging data from the recently announced MOUNTAIN six-month follow-up period and the topline interim SHORELINE Study analysis, suggest the potential for zuranolone, if successfully developed and approved, to be uniquely positioned as a disruptive, distinct and novel treatment approach for patients. Biogen and Sage believe that zuranolone is clinically active in MDD based on the data compiled to date and look forward to planned data readouts in 2021.

    Sage is pursuing three development pathways for zuranolone in the U.S.: PPD; acute rapid response therapy (RRT) in MDD when co-initiated with new standard antidepressant therapy; and "as-needed," or episodic, treatment of MDD. As a result, Sage is advancing four additional pivotal studies evaluating a 50 mg dose of zuranolone: a Phase 3 study in PPD (SKYLARK, PPD-301), a Phase 3 study of use as an acute RRT in patients with MDD when co-initiated with new standard antidepressant therapy (CORAL, MDD-305), a Phase 3 study in the acute treatment of MDD (WATERFALL, MDD-301B) and an open label Phase 3 study evaluating the long-term safety, tolerability and efficacy of "as-needed" repeat treatment (SHORELINE, MDD-303). Data from these studies are expected in 2021.

    Upon closing of the transaction, Biogen and Sage will collaborate to further define the development and commercialization strategy for zuranolone. Beyond PPD and MDD, zuranolone may also have potential in other psychiatric disorders including bipolar disorder and generalized anxiety disorder.

    SAGE-324 is a next-generation positive allosteric modulator of GABAA receptors in Phase 2 development for essential tremor with potential in other neurological conditions such as epilepsy and PD. Essential tremor is one of the most common movement disorders estimated to affect over six million patients in the U.S., and current standard of care may be inadequate for many. Following encouraging results from a Phase 1 open-label study in essential tremor, Sage advanced SAGE-324 to the Phase 2a KINETIC Study, which Sage is currently conducting. The KINETIC Study is a 28-day placebo-controlled study in patients with essential tremor expected to read out in 2021. Upon closing of the transaction, Biogen and Sage will collaborate to further define the development and commercialization strategy for SAGE-324 in essential tremor and, as appropriate, for potential expansion into other neurological disorders.

    Terms of the Collaboration

    The strategic collaboration is global in scope and under the terms of the agreement, Sage will receive $1.525 billion in cash to be comprised of an upfront payment of $875 million and a $650 million equity investment in Sage from the purchase of approximately 6.2 million newly issued shares of Sage common stock at a price of $104.14 per share, representing a premium of 40 percent over the 30-day volume-weighted average share price of $74.39 per share as of November 25, 2020.

    Should the zuranolone and SAGE-324 programs achieve certain development and commercial milestones, Sage will be eligible to receive up to approximately $1.6 billion in potential milestone payments.

    Biogen and Sage will share responsibility and costs for development as well as profits and losses for commercialization in the U.S. (50 percent Biogen; 50 percent Sage). Outside the U.S., Biogen will be responsible for development and commercialization, excluding Japan, Taiwan and South Korea with respect to zuranolone, and will pay Sage tiered royalties in the high teens to low twenties.

    Closing of the transaction is contingent on completion of review under antitrust laws, including the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976 in the U.S., and other customary closing conditions. The transaction is expected to close by the end of January 2021.

    BofA Securities and Guggenheim Securities acted as financial advisors to Biogen. Goldman Sachs & Co. LLC is acting as the exclusive financial advisor to Sage.

    Conference Call Information

    Sage will host a conference call to discuss the collaboration Monday, November 30 at 8:00 a.m. ET. 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.

    On Monday, November 30 at 9:00 a.m. ET, Biogen will host a live conference call to discuss the collaboration, which will be accessible through the Investors section of Biogen's website, www.biogen.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, immunology, neurocognitive disorders, acute neurology and 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.

    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.

    Biogen Safe Harbor

    This news release contains forward-looking statements, made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements relating to the potential benefits and results that may be achieved through Biogen's proposed collaboration with Sage; the anticipated completion and timing of the proposed transaction; the potential benefits, safety and efficacy of zuranolone and SAGE-324; the clinical development program and data readouts for zuranolone and SAGE-324; the potential treatment of depression, including MDD and PPD, essential tremor and other neurological disorders; the potential of Biogen's commercial business and pipeline programs; Biogen's strategy and plans; risks and uncertainties associated with drug development and commercialization; and Biogen's future financial and operating results. These forward-looking statements may be accompanied by words such as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "goal," "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: risks that the proposed transaction will not be completed in a timely manner or at all; the possibility that certain closing conditions to the proposed transaction will not be satisfied; uncertainty as to whether the anticipated benefits of the proposed collaboration can be achieved; risks of unexpected hurdles, costs or delays; uncertainty of success in the development and potential commercialization of zuranolone and SAGE-324, which may be impacted by, among other things, unexpected concerns that may arise from additional data or analysis, the occurrence of adverse safety events, failure to obtain regulatory approvals in certain jurisdictions, 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 Biogen's 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 risks 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.

    Sage Therapeutics Safe Harbor

    This news release contains forward-looking statements, made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements relating to: the potential benefits and results that may be achieved through Sage's proposed collaboration with Biogen; the anticipated completion of the proposed transaction; the anticipated payments that may be received if all milestones under the agreement with Biogen are met; the potential benefits, safety and efficacy of zuranolone and SAGE-324, and the potential of the product candidates, if successful, to change the way certain diseases and disorders are treated; the planned clinical development program and expected timing of data readouts for zuranolone and SAGE-324; the potential for successful development and approval of zuranolone and SAGE-324 and the potential for future commercialization; estimates as to the number of patients with MDD, PPD and essential tremor; and the goals, opportunity and potential for Sage's business. 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 Sage's control, which could cause actual results to differ materially from those contemplated in these forward-looking statements, including the risks that: the proposed transaction may not be completed in a timely manner or at all; certain closing conditions to the proposed transaction may not be satisfied; the anticipated benefits of the proposed collaboration may never be achieved; results from interim data cuts from a clinical study may not be reflective of the results that will be achieved in the full study once completed; success in non-clinical studies or in earlier clinical trials 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 or be sufficient to file for or gain regulatory approval to market a product without further development work or may not support further development at all; adverse results may occur at any stage of development that negatively impact further development or that require additional nonclinical and clinical work which may not yield positive results; different or more severe adverse events may occur at the higher doses of zuranolone or SAGE-324 currently being studied; issues may arise with the efficacy or durability of short-term treatment, or co-initiated treatment with zuranolone or there may be safety and efficacy concerns with respect to retreatment with zuranolone or chronic treatment with SAGE-324 that require additional nonclinical studies or clinical trials be conducted; delays in initiation of dosing or conduct or completion of ongoing and planned clinical trials may occur that may impact expected timelines; COVID-19 may impact clinical development timelines; the FDA may ultimately decide that the design or results of completed and planned clinical trials for zuranolone or SAGE-324, even if positive, are not sufficient for regulatory approval in the indications that are the focus of our development plan; the actual size of the MDD, PPD and essential tremor patient populations may be significantly lower than estimates; Sage may not obtain the operational, strategic or financial flexibility or value creation opportunities it expects from the collaboration with Biogen; there may be other unexpected hurdles in the development and manufacture of zuranolone or SAGE-324 which may delay or impact planned activities or results; as well as those risks more fully discussed in the section entitled "Risk Factors" in Sage's 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 Sage's views only as of today, and should not be relied upon as representing Sage's views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements.

    BIOGEN MEDIA CONTACT:BIOGEN INVESTOR CONTACT:
    David CaouetteJoe Mara
    Biogen Inc.Biogen Inc.
    Tel: (781) 464-3260Tel: (781) 464-2442
      
    SAGE MEDIA CONTACT:SAGE INVESTOR CONTACT:
    Maureen L. SudaJeff Boyle
    Sage TherapeuticsSage Therapeutics
    Tel: (617) 949-4289Tel: (617) 949-4256
    Email: Email:


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  2. Ongoing zuranolone Phase 3 pivotal trials in major depression and postpartum depression progressing well; expect to initiate dosing in CORAL Study in 4Q 2020

    Continued execution across brain health franchises highlighted during 2nd annual FutureCast event

    First patient dosed in PARADIGM Study investigating SAGE-718 in patients with Parkinson's disease cognitive dysfunction

    Conference call today at 8:30 a.m. ET

    Today, 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, reported business highlights and financial results for the third quarter ended September 30, 2020.

    "Today I'm pleased to report…

    Ongoing zuranolone Phase 3 pivotal trials in major depression and postpartum depression progressing well; expect to initiate dosing in CORAL Study in 4Q 2020

    Continued execution across brain health franchises highlighted during 2nd annual FutureCast event

    First patient dosed in PARADIGM Study investigating SAGE-718 in patients with Parkinson's disease cognitive dysfunction

    Conference call today at 8:30 a.m. ET

    Today, 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, reported business highlights and financial results for the third quarter ended September 30, 2020.

    "Today I'm pleased to report that our clinical programs across three franchises remain on track, with a series of key milestones anticipated over the next 12 to 18 months," said Mike Cloonan, chief operating officer at Sage Therapeutics. "During the third quarter, we continued progress across our deep and robust clinical pipeline, a pipeline that spans multiple disease states with programs in early, mid and late stage development. The Sage team continues to execute well during the COVID-19 pandemic and remains determined to provide much needed options to patients suffering with debilitating brain health disorders."

    Recent updates

    Sage recently reported positive, interim topline results from a July data cut of the ongoing Phase 3 open-label SHORELINE Study of zuranolone in major depressive disorder (MDD). The data analyzed to date show that zuranolone was generally well-tolerated in the 30 mg dose and among the initial patients treated with the 50 mg dose. Adverse events reported in the trial during the period analyzed were generally consistent with results seen in previous zuranolone clinical trials.

    As the first naturalistic, longitudinal, clinical development trial conducted in MDD, the SHORELINE Study provides real world insight into the potential use of zuranolone, if successfully developed and approved as an as-needed treatment for MDD, and builds on the data assembled in the LANDSCAPE clinical program. The Company plans to report comprehensive data from the 30 mg dose of the SHORELINE Study in the first half of 2021 and will include additional analyses of the data set.

    Portfolio Updates

    Sage is advancing a portfolio of novel, new 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.

    Depression Franchise

    Sage's depression franchise features zuranolone, Sage's next-generation positive allosteric modulator (PAM) of GABAA receptors being evaluated in clinical development as a treatment for various affective disorders and ZULRESSO® (brexanolone) CIV injection, approved by the U.S. Food and Drug Administration (FDA) as the first treatment specifically indicated for postpartum depression (PPD). Zuranolone has received breakthrough therapy designation from the FDA for the treatment of MDD.

    • Zuranolone ongoing studies: Sage is evaluating the potential of zuranolone as a rapid-acting, short-course treatment for PPD and MDD. Sage recently initiated three new short-term clinical studies in 2020, with the potential along with the rest of the program, if successful, to support three distinct indications: PPD, acute rapid response therapy (RRT) in MDD when co-initiated with a new standard antidepressant, and as-needed, or episodic, treatment of MDD. Enrollment and dosing are now ongoing in two of these trials:



      • SKYLARK (PPD-301) Study investigating zuranolone as an oral therapy in women with PPD:
        • Placebo-controlled trial evaluating a two-week course of zuranolone 50 mg in women with PPD, with additional short-term follow-up.
        • Topline data from this study are anticipated in 2021.



      • WATERFALL (MDD-301B) Study investigating zuranolone for the as-needed, or episodic, treatment of MDD:
        • Placebo-controlled trial evaluating a two-week course of zuranolone 50 mg in patients with MDD, with additional short-term follow-up.
        • Topline data from this study are anticipated in the first half of 2021.

    Sage expects to initiate dosing of the third new zuranolone Phase 3 trial in 2020:

    • CORAL (MDD-305) Study investigating zuranolone for acute RRT in patients with MDD when co-initiated with a newly administered standard antidepressant therapy:
      • Placebo-controlled trial evaluating a two-week course of zuranolone 50 mg, when co-initiated with a new open-label antidepressant, in patients with MDD, with additional short-term follow-up.
      • Topline data from this study are anticipated in 2021.
    • Sage is also currently evaluating the ongoing zuranolone clinical pharmacology and safety program and plans to finalize requirements to support a potential future new drug application (NDA) with the FDA.
    • ZULRESSO® (brexanolone) CIV injection:
      • Revenue in the third quarter of 2020 from sales of ZULRESSO was $1.6 million, compared to $1.5 million in the third quarter of 2019. As previously announced, due to the ongoing impact of the COVID-19 pandemic, the Company expects de minimis revenue for the balance of 2020, and expects future revenue growth to be limited even after the pandemic as a result of the significant barriers to treatment and the refocus of Sage's commercialization efforts after the April 2020 restructuring.
      • The Company has received clearance from the FDA, under the Coronavirus Treatment Acceleration Program (CTAP), to initiate a Phase 3 study with brexanolone in patients with advanced COVID-19 related acute respiratory distress syndrome (ARDS). The Company expects to initiate patient dosing in this study in the fourth quarter of 2020.
        • Topline data from this study are anticipated in 2021.

    Neurology Franchise

    SAGE-324, a next-generation PAM of GABAA receptors and Sage's lead neurology asset, is in development as a potential oral therapy for neurological conditions, such as essential tremor (ET), epilepsy and Parkinson's disease (PD).

    • KINETIC Study: The KINETIC Study (324-ETD-201), a placebo-controlled Phase 2 study evaluating the safety and efficacy of SAGE-324 in patients with ET is ongoing. Patients in the study receive a once-daily, four-week course of SAGE-324 60 mg or placebo.
      • Topline data from this study are now anticipated in 1Q 2021.

    Neuropsychiatry Franchise

    SAGE-718, Sage's first-in-class NMDA receptor PAM and lead neuropsychiatric drug candidate, is in development as a potential oral therapy for cognitive disorders associated with NMDA receptor dysfunction, potentially including Huntington's disease (HD), PD and Alzheimer's disease (AD).

    • PARADIGM Study: The Company initiated enrollment and dosing in the PARADIGM Study (718-CNP-201), a Phase 2a open-label study evaluating SAGE-718 in patients with PD cognitive dysfunction.
      • Topline data from this study are now anticipated in the first quarter of 2021.
    • LUMINARY Study: The Company expects to initiate dosing in the LUMINARY Study (718-CNP-201), a Phase 2a open-label study evaluating SAGE-718 in patients with AD cognitive dysfunction and mild dementia in the fourth quarter of 2020.

    Results from these studies will inform potential advancement of SAGE-718 into further development.

    Corporate Updates

    During the third quarter, the Company strengthened its leadership with two key additions:

    • Barry Greene was appointed to Sage's Board of Directors. He was most recently President of Alnylam Pharmaceuticals, Inc.
    • Tammy Phinney joined the Company's management team as senior vice president, regulatory affairs. Her extensive experience leading regulatory functions in the neurology therapeutic area over the last 15 years is well-aligned with Sage's significant regulatory needs as the Company is anticipating several potential FDA engagements as its pipeline advances. Most recently, she served as Vice President, Head of US, Regulatory Affairs at EMD Serono.

    The Company also hosted the 2nd annual "FutureCast: An R&D Portfolio Review" in the third quarter to review the Company's research and development strategy, and clinical progress in its key depression, neurology, and neuropsychiatry franchise programs.

    Anticipated Upcoming Milestones

    Q4 2020

    • Zuranolone:
      • Initiate dosing in Phase 3 CORAL Study (MDD-305) evaluating zuranolone 50 mg, when co-initiated with a new open-label antidepressant, as an acute rapid response therapy in patients with MDD.
    • Brexanolone:
      • Initiate dosing in Phase 3 study in patients with advanced COVID-19 related acute respiratory distress syndrome (ARDS).
    • SAGE-718
      • Initiate dosing in Phase 2a LUMINARY open-label, signal finding study in patients with Alzheimer's disease cognitive dysfunction and mild dementia.

    2021

    • Zuranolone:
      • Report topline data from Phase 3 WATERFALL Study (1H 2021).
      • Report topline data from Phase 3 SKYLARK Study.
      • Report topline data from Phase 3 CORAL Study.
      • Report topline data from Phase 3 SHORELINE Study (30 mg full data set – 1H 2021; 50 mg topline data – 2H 2021).
    • SAGE-324:
      • Report topline data from Phase 2 placebo-controlled KINETIC Study in essential tremor (1Q 2021).
    • SAGE-718:
      • Report topline data from Phase 2a PARADIGM open-label, signal finding study in patients with Parkinson's disease cognitive dysfunction (1Q 2021).
    • Brexanolone:
      • Report topline data from Phase 3 study in patients with advanced COVID-19 related ARDS.

    Financial Results for the Third Quarter 2020

    • Revenue: Sage recorded $1.6 million in net revenue in the third quarter of 2020 from sales of ZULRESSO, compared to $1.5 million for the same period in 2019. Sage recorded no collaboration revenue in the third quarter of 2020 compared to $2.1 million in collaboration revenue from Shionogi & Co., Ltd. related to reimbursement of product expense for the same period in 2019.
    • Cash Position: Cash, cash equivalents, restricted cash, and marketable securities as of September 30, 2020 were $671 million compared to $759 million at June 30, 2020.
    • R&D Expenses: Research and development expenses were $74.1 million, including $9.9 million of non-cash stock-based compensation expense, in the third quarter of 2020 compared to $102.1 million, including $17.1 million of non-cash stock-based compensation expense, for the same period in 2019. The decrease in R&D expenses was primarily related to the completion of the MOUNTAIN Study, a Phase 3 clinical trial of zuranolone in MDD; the decrease in non-cash stock-based compensation expense and decreased spending for clinical pharmacology studies, partially offset by an increase in spending for the WATERFALL Study, a Phase 3 clinical trial of zuranolone in MDD.
    • SG&A Expenses: Selling, general and administrative expenses were $35.1 million, including $10.2 million of non-cash stock-based compensation expense, in the third quarter of 2020 compared to $88.5 million, including $26.6 million of non-cash stock-based compensation expense, for the same period in 2019. The decrease in SG&A expenses was primarily due to the restructuring that the Company announced during the second quarter of 2020.
    • Net Loss: Net loss was $105.7 million for the third quarter of 2020, compared to $180.0 million for the same period in 2019.

    Financial Guidance

    • Sage anticipates a cash balance of at least $550 million at end of 2020, which the Company anticipates will support operations into 2022 based on current operating plans.

    Conference Call Information

    Sage will host a conference call and webcast today, Thursday, November 5, at 8:30 a.m. ET to discuss its third quarter 2020 financial results and recent corporate updates. 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 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 revenues from sales of ZULRESSO; our clinical development plans and expected timelines; our expectations with respect to 2020 operating expenses and year-end cash; our belief that existing cash will support operations into 2022; our belief in the potential of our product candidates in various indications; the potential profile and benefit of our product candidates; and the goals, opportunity and potential 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 never be able to generate meaningful revenues from sales of ZULRESSO or to generate revenues at levels necessary to justify our investment; the impact of the COVID-19 pandemic on sales of ZULRESSO may last longer than we expect or may reoccur in waves; our post-restructuring focus on geographies where there are existing, active ZULRESSO treating sites may not be sufficient for us to achieve success from the sale of ZULRESSO or to generate revenues at meaningful levels or at levels necessary to justify our investment even after the impact of the COVID-19 pandemic lessens; we may not be able to overcome the barriers to treatment with ZULRESSO or we may continue to encounter other issues or challenges in commercializing ZULRESSO which could further limit the potential of ZULRESSO and the timing and amount of future revenues; results achieved with use of ZULRESSO in the treatment of PPD in commercial use may be different than observed in clinical trials, and may vary among patients; the number of patients with the diseases or disorders for which our products are developed or the unmet need for additional treatment options may be significantly smaller than we expect; we may encounter delays in initiation, conduct or completion of our ongoing and planned clinical trials, including as a result of slower than expected site initiation or enrollment, the need or decision to expand the trials or other changes, that may impact our ability to meet our expected time-lines and increase our costs; we may not be able to mitigate the impact of COVID-19 on our clinical development timelines and the impact may be more significant than we expect and may negatively impact expected site initiation, enrollment or conduct in our clinical trials, or cause us to pause trials or not be able to use data, in each case which may significantly impact our ability to meet our expected time-lines or may significantly impact the integrity or sufficiency of the data from our trials or increase our costs or cause us to have to change our plans; 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; our expectations as to expenses, year-end cash and cash needs may prove not to be correct for 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; we may not be successful in our development of any of our product candidates in any indication we are currently pursuing or may in the future pursue; success in our non-clinical studies or in earlier clinical trials may not be repeated or observed in ongoing or future studies, and ongoing and future non-clinical and clinical results or at interim time periods may not meet their primary or key secondary endpoints or be sufficient to file for or gain regulatory approval to market the product without further development work or may not support further development at all; we may encounter 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 different or more severe adverse events at the higher doses we are studying in new trials; we may encounter issues with the efficacy or durability of short-term treatment, or co-initiated treatment with zuranolone or safety and efficacy concerns with respect to retreatment that require additional studies be conducted; the FDA may ultimately decide that the design or results of our completed and planned clinical trials for any of our product candidates, even if positive, are not sufficient for regulatory approval in the indications that are the focus of our development plan; other 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; we may encounter technical and other unexpected hurdles in the development and manufacture of our product candidates which may delay our timing or change our plans or increase our costs; 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.

    Sage Therapeutics, Inc. and Subsidiaries

    Condensed Consolidated Statements of Operations

    (in thousands, except share and per share data)

    (unaudited)

     

    Three Months Ended September 30,

     

    Nine Months Ended September 30,

    2020

     

    2019

     

    2020

     

    2019

    Product revenue, net

    $

    1,639

     

    $

    1,478

     

    $

    5,014

     

    $

    1,997

     

    Collaboration revenue

     

    -

     

     

    2,092

     

     

    -

     

     

    2,911

     

    Total revenue

     

    1,639

     

     

    3,570

     

     

    5,014

     

     

    4,908

     

     
    Operating costs and expenses:
    Cost of goods sold

     

    149

     

     

    137

     

     

    429

     

     

    181

     

    Research and development

     

    74,078

     

     

    102,108

     

     

    211,008

     

     

    277,565

     

    Selling, general and administrative

     

    35,099

     

     

    88,502

     

     

    143,454

     

     

    260,648

     

    Restructuring

     

    (529

    )

     

    -

     

     

    27,873

     

     

    -

     

    Total operating costs and expenses

     

    108,797

     

     

    190,747

     

     

    382,764

     

     

    538,394

     

    Loss from operations

     

    (107,158

    )

     

    (187,177

    )

     

    (377,750

    )

     

    (533,486

    )

     
    Interest income, net

     

    1,347

     

     

    7,227

     

     

    8,763

     

     

    21,889

     

    Other income (expense), net

     

    76

     

     

    (8

    )

     

    165

     

     

    12

     

    Net loss

    $

    (105,735

    )

    $

    (179,958

    )

    $

    (368,822

    )

    $

    (511,585

    )

    Net loss per share - basic and diluted

    $

    (2.03

    )

    $

    (3.48

    )

    $

    (7.10

    )

    $

    (10.13

    )

    Weighted average shares outstanding - basic and diluted

     

    51,981,468

     

     

    51,704,687

     

     

    51,938,923

     

     

    50,496,489

     

    Sage Therapeutics, Inc. and Subsidiaries

    Condensed Consolidated Balance Sheets

    (in thousands)

    (unaudited)

     

    September 30,

    2020

    December 31,

    2019

    Cash, cash equivalents, restricted cash and investments

    $

    670,904

    $

    1,010,760

    Total assets

    $

    738,628

    $

    1,084,150

    Total liabilities

    $

    81,047

    $

    139,495

    Total stockholders' equity

    $

    657,581

    $

    944,655

    About ZULRESSO® (brexanolone) CIV injection

    ZULRESSO, the first medicine specifically approved by the U.S. Food and Drug Administration (FDA) for the treatment of postpartum depression (PPD) in adults, is a positive allosteric modulator of both synaptic and extrasynaptic GABAA receptors. Allosteric modulation of neurotransmitter receptor activity results in varying degrees of desired activity rather than complete activation or inhibition of the receptor.

    SELECT IMPORTANT SAFETY INFORMATION

    These are not all the side effects of ZULRESSO.

    ZULRESSO can cause serious side effects, including:

    • Excessive sedation and sudden loss of consciousness. ZULRESSO may cause you to feel very sleepy (excessive sedation) or pass out (loss of consciousness). Your healthcare provider should check you for symptoms of excessive sleepiness every 2 hours while you are awake.
      • During your infusion, tell your healthcare provider right away if you feel like you cannot stay awake during the time you are normally awake or if you feel like you are going to pass out. Your healthcare provider may lower your dose or stop the infusion until symptoms go away
      • You must have a caregiver or family member with you to help care for your child(ren) during your infusion
    • Because of the risk of serious harm resulting from excessive sedation or sudden loss of consciousness, ZULRESSO is only available through a restricted program called the ZULRESSO REMS.

    ZULRESSO can cause other serious side effects, including:

    • Increased risk of suicidal thoughts or actions. ZULRESSO and other antidepressant medicines may increase suicidal thoughts and actions in some people 24 years of age and younger. Pay close attention to and tell your healthcare provider right away if you have any of the following symptoms, especially if they are new, worse, or worry you:
      • Attempts to commit suicide, thoughts about suicide or dying, new or worse depression, other unusual or sudden changes in behavior or mood
      • Keep all follow-up visits and call your healthcare provider between visits as needed, especially if you have concerns about symptoms.

    The most common side effects of ZULRESSO include:

    • Sleepiness, dry mouth, passing out, flushing of the skin or face.

    Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    Before receiving ZULRESSO, tell your healthcare provider about all your medical conditions including if you drink alcohol, have kidney problems, are pregnant or think you may be pregnant, or are breastfeeding or plan to breastfeed. It is not known if ZULRESSO will harm your unborn baby. If you become pregnant during treatment, talk with your healthcare provider about enrolling with the National Pregnancy Registry for Antidepressants at 1-844-405-6185.

    While receiving ZULRESSO, avoid the following:

    • Driving a car or doing other dangerous activities after your ZULRESSO infusion until your feeling of sleepiness has completely gone away
    • Do not drink alcohol

    Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. ZULRESSO and some medicines may interact with each other and cause serious side effects.

    Especially tell your healthcare provider if you take other antidepressants, opioids, or Central Nervous System (CNS) depressants (such as benzodiazepines).

    Please see the patient Medication Guide, including information about serious side effects, for Zulresso in the full Prescribing Information.

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  3. 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 that the Company will present at the following investor conferences in November:

    • Stifel Virtual Healthcare Conference: fireside chat on Monday, November 16, 2020 at 8:40 am ET.
    • Wolfe Research Virtual Healthcare Conference: fireside chat on Thursday, November 19, 2020 at 4:05 pm ET.

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

    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 that the Company will present at the following investor conferences in November:

    • Stifel Virtual Healthcare Conference: fireside chat on Monday, November 16, 2020 at 8:40 am ET.
    • Wolfe Research Virtual Healthcare Conference: fireside chat on Thursday, November 19, 2020 at 4:05 pm ET.

    A live webcast of each presentation can be accessed on the investor page of Sage's website at investor.sagerx.com. A replay of the webcasts 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
  4. Today, 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, announced that Jeff Jonas, M.D., chief executive officer, will undergo a scheduled surgical procedure today. The Company anticipates he will make a full recovery and return to his role full-time in December 2020. While Dr. Jonas is recuperating, he will be available as needed, and during this time, the Sage leadership team will direct business operations. In addition, Sage's experienced Board of Directors will continue to serve as a resource.

    About Sage Therapeutics

    Sage Therapeutics is a biopharmaceutical company committed to developing…

    Today, 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, announced that Jeff Jonas, M.D., chief executive officer, will undergo a scheduled surgical procedure today. The Company anticipates he will make a full recovery and return to his role full-time in December 2020. While Dr. Jonas is recuperating, he will be available as needed, and during this time, the Sage leadership team will direct business operations. In addition, Sage's experienced Board of Directors will continue to serve as a resource.

    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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