Articles from Sage Therapeutics, Inc.

Sage Therapeutics, Inc. (NASDAQSAGE), today announced that it will host a live webcast on Tuesday, February 11, 2025 at 4:30 p.m. ET to review fourth quarter and full year 2024 financial results and discuss recent business updates.

Sage Therapeutics, Inc. (Nasdaq: SAGE) (“Sage” or “the Company”), today announced that its Board of Directors has initiated a process to explore strategic alternatives for the Company. The Board intends to evaluate a broad range of opportunities to maximize value for shareholders, including but not limited to a potential strategic transaction, business combination or sale.

Sage Therapeutics, Inc. (Nasdaq: SAGE) (“The Company”), today confirmed that Biogen Inc. (Nasdaq: BIIB) (“Biogen”) has submitted to the Company an unsolicited, nonbinding proposal to acquire all of the outstanding shares of Sage Therapeutics not already owned by Biogen for $7.22 per share.

Sage Therapeutics, Inc. (NASDAQSAGE), today announced that the Company will participate in a fireside chat at the Piper Sandler 36th Annual Healthcare Conference on Wednesday, December 4, 2024, at 9:00 a.m. ET in New York, NY.

Sage Therapeutics, Inc. (Nasdaq: SAGE) today announced topline results from the Phase 2 DIMENSION Study of dalzanemdor (SAGE-718) in participants with cognitive impairment (CI) associated with Huntington’s Disease (HD). In the study, dalzanemdor did not demonstrate a statistically significant difference versus placebo on the primary endpoint, the change from baseline on the Symbol Digit Modalities Test (SDMT) at Day 84. Analyses of secondary endpoints did not demonstrate statistically significant or clinically meaningful differences in participants treated with dalzanemdor compared to placebo. Based on these results, the Company does not plan further development of dalzanemdor.

Sage Therapeutics, Inc. (Nasdaq: SAGE), today reported business highlights and financial results for the third quarter ended September 30, 2024.

Sage Therapeutics, Inc. (Nasdaq: SAGE), today announced a strategic reorganization of its business operations to support the ongoing launch of ZURZUVAE in postpartum depression and focus pipeline development efforts ahead of a clinical study readout for dalzanemdor in Huntington’s Disease expected later this year. The reorganization is intended to enable Sage to strengthen its balance sheet, extend cash runway, and position the company for long-term growth potential.

Sage Therapeutics, Inc. (NASDAQSAGE), today announced that it will host a live webcast on Tuesday, October 29, 2024 at 4:30 p.m. ET to review third quarter 2024 financial results and discuss recent business updates.

Sage Therapeutics, Inc. (Nasdaq: SAGE) announced today topline results from LIGHTWAVE, a 12-week, Phase 2 randomized, double-blind, placebo-controlled study to evaluate the effects of dalzanemdor (SAGE-718) in participants with mild cognitive impairment (MCI) or mild dementia due to Alzheimer’s Disease (AD). The LIGHTWAVE Study did not demonstrate a statistically significant difference from baseline in participants treated with dalzanemdor versus placebo on the Wechsler Adult Intelligence Scale Fourth Edition (WAIS-IV) Coding Test score at Day 84, the primary outcome measure of the study.

Sage Therapeutics, Inc. (NASDAQSage) today announced that Biogen has terminated its rights under the collaboration and license agreement with Sage specific to the SAGE-324 program. The companies recently announced negative results from the Phase 2 KINETIC 2 Study of investigational SAGE-324 for the chronic treatment of essential tremor (ET) and discontinued further clinical development of SAGE-324 in ET.

Sage Therapeutics, Inc. (Nasdaq: SAGE), a biopharmaceutical company leading the way to create a world with better brain health, today reported business highlights and financial results for the second quarter ended June 30, 2024.

Sage Therapeutics, Inc. (NASDAQSage) and Biogen Inc. NASDAQ: BIIBNASDAQBIIB)

Sage Therapeutics, Inc. (NASDAQSAGE), a biopharmaceutical company leading the way to create a world with better brain health, today announced that it will host a live webcast on Wednesday, July 31, 2024 at 4:30 p.m. ET to review second quarter 2024 financial results and discuss recent business updates.

Sage Therapeutics, Inc. (NASDAQSAGE), a biopharmaceutical company leading the way to create a world with better brain health, announced today that the Company will participate in a fireside chat at the Goldman Sachs 45th Annual Global Healthcare Conference on Wednesday, June 12, 2024, at 2:00 p.m. ET in Miami, FL.

Sage Therapeutics, Inc. (Nasdaq: SAGE), a biopharmaceutical company leading the way to create a world with better brain health, today reported business highlights and financial results for the first quarter ended March 31, 2024.

Sage Therapeutics, Inc. (Nasdaq: SAGE) announced today topline results from PRECEDENT, a double-blind, placebo-controlled Phase 2 study of the investigational oral medicine dalzanemdor (SAGE-718) in people with mild cognitive impairment (MCI) in Parkinson’s Disease (PD). The PRECEDENT Study did not meet its primary endpoint of demonstrating statistically significant difference from baseline in participants treated with once-daily dalzanemdor versus placebo on the Wechsler Adult Intelligence Scale Fourth Edition-IV (WAIS-IV) Coding Test score at Day 42. Dalzanemdor (SAGE-718) was generally well-tolerated, and there were no new safety signals observed.

Sage Therapeutics, Inc. (NASDAQSAGE), a biopharmaceutical company leading the way to create a world with better brain health, today announced that it will host a live webcast on Thursday, April 25, 2024 at 8:00 a.m. ET to review first quarter 2024 financial results and discuss recent business updates.

Sage Therapeutics, Inc. (NASDAQSAGE), a biopharmaceutical company leading the way to create a world with better brain health, announced today that the Company will present at the following upcoming investor conferences in March:

Sage Therapeutics, Inc. (Nasdaq: SAGE), a biopharmaceutical company leading the way to create a world with better brain health, today reported business highlights and financial results for the fourth quarter and full year ended December 31, 2023.

Sage Therapeutics, Inc. (NASDAQSAGE), a biopharmaceutical company leading the way to create a world with better brain health, today announced that it will host a live webcast on Wednesday, February 14, 2024 at 8:00 a.m. ET to review fourth quarter and full year 2023 financial results and discuss recent business updates.

Sage Therapeutics, Inc. (Nasdaq: SAGE), a biopharmaceutical company leading the way to create a world with better brain health, today announced that Chief Executive Officer Barry Greene will discuss the Company’s key business drivers for 2024 at the 42nd Annual J.P. Morgan Healthcare Conference in San Francisco, California.

Sage Therapeutics, Inc. (Nasdaq: SAGE), a biopharmaceutical company leading the way to create a world with better brain health, today announced the retirement of Kevin Starr from the company’s board of directors. Geno Germano has assumed the role of Chair of the Board of Directors.

Sage Therapeutics, Inc. (NASDAQSAGE), a biopharmaceutical company leading the way to create a world with better brain health, announced today that the Company will present at the 42nd Annual J.P. Morgan Healthcare Conference on Monday, January 8, 2024 at 4:30 p.m. PT in San Francisco, CA.

Sage Therapeutics, Inc. (Nasdaq: SAGE) and Biogen Inc. (Nasdaq: BIIB) announced ZURZUVAE™ (zuranolone) 50 mg (two 25 mg capsules per day) CIV is now available by prescription for the treatment of postpartum depression (PPD) for adults in the United States, with product already at specialty pharmacies and delivered to patients. ZURZUVAE is the first and only oral, 14-day treatment course for adults with PPD that can provide rapid improvements in depressive symptoms at Day 15 and as early as Day 3.

Sage Therapeutics, Inc. (NASDAQSAGE), a biopharmaceutical company leading the way to create a world with better brain health, announced today that the Company will present at the following upcoming investor conferences in November:

Sage Therapeutics, Inc. (Nasdaq: SAGE) today reported business highlights and financial results for the third quarter ended September 30, 2023.

Sage Therapeutics, Inc. (Nasdaq: SAGE), a biopharmaceutical company leading the way to create a world with better brain health, announced today that it will host a live webcast on Tuesday, November 7, 2023 at 8:00 a.m. ET to review third quarter 2023 financial results and discuss recent business updates.

Sage Therapeutics, Inc. (Nasdaq: SAGE), a biopharmaceutical company leading the way to create a world with better brain health, today announced the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to SAGE-718 for the treatment of Huntington’s disease (HD). SAGE-718 is in development as a potential oral therapy for cognitive disorders associated with NMDA receptor dysfunction. Multiple clinical studies are ongoing with SAGE-718 across several disease areas, including two placebo-controlled Phase 2 studies and a Phase 3 open-label safety study in the potential lead indication of HD-related cognitive impairment, as well as Phase 2 placebo-controlled studies in mild cognitive impairment (MCI) associated with Parkinson’s disease (PD) and MCI and mild dementia due to Alzheimer’s disease (AD).

Sage Therapeutics, Inc. (NASDAQSAGE), a biopharmaceutical company leading the way to create a world with better brain health, announced today that the Company will present at the following upcoming investor conferences in September:

Sage Therapeutics, Inc. (Nasdaq: SAGE), today announced plans to reorganize its business operations and pipeline priorities to support goals for long-term business growth, including the planned commercial launch of ZURZUVAE for women with postpartum depression (PPD) in late 2023.

Sage Therapeutics, Inc. (Nasdaq: SAGE), a biopharmaceutical company leading the way to create a world with better brain health, today reported business highlights and financial results for the second quarter ended June 30, 2023.

Sage Therapeutics, Inc. (Nasdaq: SAGE), a biopharmaceutical company leading the way to create a world with better brain health, announced today that it will host a live webcast on Monday, August 7, 2023 at 8:00 a.m. ET to provide a business update. Second quarter 2023 financial results will also be announced on Monday, August 7.

Sage Therapeutics, Inc. (Nasdaq: SAGE) and Biogen Inc. (Nasdaq: BIIB) announced the U.S. Food and Drug Administration (FDA) approved ZURZUVAETM (zuranolone) 50 mg for adults with postpartum depression (PPD). ZURZUVAE is the first and only oral, once-daily, 14-day treatment that can provide rapid improvements in depressive symptoms for women with PPD. ZURZUVAE is expected to launch and be commercially available in the fourth quarter of 2023 shortly following scheduling as a controlled substance by the U.S. Drug Enforcement Administration, which is anticipated to occur within 90 days.

Sage Therapeutics, Inc. (NASDAQSAGE), a biopharmaceutical company leading the way to create a world with better brain health, announced today that the Company will participate in a fireside chat at the Goldman Sachs 44th Annual Global Healthcare Conference on Monday, June 12, 2023, at 11:20 a.m. PT in Dana Point, CA.

Sage Therapeutics, Inc. (NASDAQSAGE), a biopharmaceutical company leading the way to create a world with better brain health, announced today that the Company will present at the following upcoming investor conferences in May:

Sage Therapeutics, Inc. (Nasdaq: SAGE), a biopharmaceutical company leading the way to create a world with better brain health, today reported business highlights and financial results for the first quarter ended March 31, 2023.

Sage Therapeutics, Inc. (Nasdaq: SAGE), a biopharmaceutical company leading the way to create a world with better brain health, announced today that it will host a live webcast on Tuesday, May 2, 2023 at 8:00 a.m. ET to review first quarter 2023 financial results and discuss recent business updates.

Sage Therapeutics, Inc. (Nasdaq: SAGE), a biopharmaceutical company leading the way to create a world with better brain health, announced today that the Company will present at the Stifel 2023 CNS Days on Wednesday, March 29, 2023, at 11:00 a.m. ET.

Sage Therapeutics, Inc. (Nasdaq: SAGE), a biopharmaceutical company leading the way to create a world with better brain health, today announced the appointment of Jessica Federer to the company’s Board of Directors.

Sage Therapeutics, Inc. (Nasdaq: SAGE) and Biogen Inc. (Nasdaq: BIIB) announced that the U.S. Food and Drug Administration (FDA) notified the companies that the agency does not currently plan to convene an advisory committee meeting to discuss the New Drug Application (NDA) for zuranolone in the treatment of major depressive disorder (MDD) and postpartum depression (PPD).

Sage Therapeutics, Inc. (NASDAQSAGE), a biopharmaceutical company leading the way to create a world with better brain health, announced today that the Company will present at the Cowen 43rd Annual Health Care Conference on Monday, March 6, 2023, at 10:30 a.m. ET in Boston, MA.

Sage Therapeutics, Inc. (Nasdaq: SAGE), a biopharmaceutical company leading the way to create a world with better brain health, today announced the European Medicines Agency (EMA) granted Orphan Drug Designation to SAGE-718 for the treatment of Huntington’s disease (HD). SAGE-718 is in development as a potential oral therapy for cognitive disorders associated with NMDA receptor dysfunction. Multiple clinical studies are ongoing with SAGE-718 across several disease areas, including two placebo-controlled Phase 2 studies and a Phase 3 open-label safety study in the lead indication of HD-related cognitive impairment, and additionally Phase 2 placebo-controlled studies in mild cognitive impairment (MCI) associated with Parkinson’s disease (PD) and MCI and mild dementia due to Alzheimer’s disease (AD).

Sage Therapeutics, Inc. (Nasdaq: SAGE), a biopharmaceutical company leading the way to create a world with better brain health, today reported business highlights and financial results for the fourth quarter and full year ended December 31, 2022.

Sage Therapeutics, Inc. (Nasdaq: SAGE) and Biogen Inc. (Nasdaq: BIIB) announced the U.S. Food and Drug Administration (FDA) has accepted the filing of a New Drug Application (NDA) for zuranolone in the treatment of major depressive disorder (MDD) and postpartum depression (PPD). Zuranolone is an investigational drug being evaluated as a 14-day, rapid-acting, once-daily, oral treatment in adults with MDD and PPD. The application has been granted priority review and the FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of August 5, 2023.

Sage Therapeutics, Inc. (Nasdaq: SAGE), a biopharmaceutical company leading the way to create a world with better brain health, announced today that it will host a live webcast on Thursday, February 16, 2023 at 8:00 a.m. ET to review fourth quarter and full year 2022 financial results and discuss recent business updates.

Sage Therapeutics, Inc. (Nasdaq: SAGE), a biopharmaceutical company leading the way to create a world with better brain health, today announced that Chief Executive Officer, Barry Greene, will discuss the Company’s progress in developing a leading brain health pipeline at the 41st Annual J.P. Morgan Healthcare Conference in San Francisco, California.

Sage Therapeutics, Inc. (NASDAQSAGE), a biopharmaceutical company leading the way to create a world with better brain health, announced today that the Company will present at the 41st Annual J.P. Morgan Healthcare Conference on Tuesday, January 10, 2023, at 10:30 a.m. PT in San Francisco, CA.

Sage Therapeutics, Inc. (Nasdaq: SAGE) and Biogen Inc. (Nasdaq: BIIB) announced the completion of the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for zuranolone in the treatment of major depressive disorder (MDD) and postpartum depression (PPD). Zuranolone is an investigational drug being evaluated as a rapid-acting, once-daily, 14-day oral short course treatment in adults with MDD and PPD. The submission completes the NDA filing that was initiated earlier this year.

Sage Therapeutics, Inc. (Nasdaq: SAGE), a biopharmaceutical company leading the way to create a world with better brain health, announced today that the Company will present at the Piper Sandler 34th Annual Healthcare Conference on Thursday, December 1, 2022, at 8:00 a.m. ET in New York, NY.

Sage Therapeutics, Inc. (Nasdaq: SAGE) and Biogen Inc. (Nasdaq: BIIB) today announced that the companies will host a joint investor webcast to discuss the planned commercialization approach and opportunity for their investigational product, zuranolone, on Tuesday, December 6 at 8:00 a.m. ET.

Sage Therapeutics, Inc. (Nasdaq: SAGE), a biopharmaceutical company leading the way to create a world with better brain health, announced today that the Company will present at the Stifel 2022 Healthcare Conference on Wednesday, November 16, 2022, at 10:55 a.m. ET in New York, NY.

Sage Therapeutics, Inc. (Nasdaq: SAGE), a biopharmaceutical company leading the way to create a world with better brain health, today reported business highlights and financial results for the third quarter ended September 30, 2022.

Sage Therapeutics, Inc. (Nasdaq: SAGE), a biopharmaceutical company leading the way to create a world with better brain health, announced today that it will host a live webcast on Tuesday, November 8, 2022 at 8:00 a.m. ET to review third quarter 2022 financial results and discuss recent business updates.

Sage Therapeutics, Inc. (Nasdaq: SAGE) and Biogen Inc. (Nasdaq: BIIB) today presented additional data from the Phase 3 SKYLARK Study of zuranolone in adult women with postpartum depression (PPD), at the 35th European College of Neuropsychopharmacology (ECNP) Congress, taking place October 15-18, 2022, in Vienna, Austria. This was the first time the SKYLARK Study was presented at a medical congress. Zuranolone is an investigational therapy being evaluated as a once-daily, 14-day oral short course treatment in adults with major depressive disorder (MDD) and PPD.

Sage Therapeutics, Inc. (Nasdaq: SAGE) and Biogen Inc. (Nasdaq: BIIB) today announced new analyses from across the development program for zuranolone, an investigational, oral, once-daily, 14-day treatment in clinical development for adult patients with major depressive disorder (MDD) and postpartum depression. The 11 new analyses are being presented at the 2022 Psych Congress in New Orleans, September 17 to 20.

Sage Therapeutics, Inc. (Nasdaq: SAGE), a biopharmaceutical company leading the way to create a world with better brain health, announced today that the Company will present at the Morgan Stanley 20th Annual Global Healthcare Conference on Monday, September 12, 2022, at 3:40 p.m. ET in New York, NY.

Sage Therapeutics, Inc. (Nasdaq: SAGE), a biopharmaceutical company leading the way to create a world with better brain health, today reported business highlights and financial results for the second quarter ended June 30, 2022.

Sage Therapeutics, Inc. (Nasdaq: SAGE), a biopharmaceutical company leading the way to create a world with better brain health, announced today that the Company will present at the following upcoming investor conferences in August:

Sage Therapeutics, Inc. (Nasdaq: SAGE), a biopharmaceutical company leading the way to create a world with better brain health, announced today that it will host a live webcast on Tuesday, August 2, 2022 at 8:00 a.m. ET to announce second quarter 2022 financial results and discuss recent business updates.

Sage Therapeutics, Inc. (Nasdaq: SAGE), a biopharmaceutical company leading the way to create a world with better brain health, announced today that the Company will present at the following upcoming investor conferences in June:

Sage Therapeutics, Inc. (Nasdaq: SAGE) and Biogen Inc. (Nasdaq: BIIB) today announced that the Phase 3 SKYLARK Study of zuranolone, an investigational oral drug being evaluated in women with postpartum depression (PPD), met its primary and all key secondary endpoints. Women treated with zuranolone 50 mg (n=98) demonstrated a statistically significant and clinically meaningful improvement in depressive symptoms at Day 15, the primary endpoint, compared to placebo (n=97) as measured by a change from baseline (CFB) in the 17-item Hamilton Rating Scale for Depression (HAMD-17) total score. The least-squares (LS) mean (SE) CFB in HAMD-17 total score at Day 15 for women who received zuranolone 50 mg was -15.6 (0.82) compared with -11.6 (0.82) for women who received placebo (LS mean difference -4.0 points; p=0.0007).

Sage Therapeutics, Inc. (Nasdaq: SAGE), a biopharmaceutical company leading the way to create a world with better brain health, announced today that the Company will give a presentation at the Bank of America Securities 2022 Healthcare Conference on Wednesday, May 11, 2022, at 8:00am PT (11:00am ET) in Las Vegas, Nev.

Sage Therapeutics, Inc. (Nasdaq: SAGE), a biopharmaceutical company leading the way to create a world with better brain health, today reported business highlights and financial results for the first quarter ended March 31, 2022.

Sage Therapeutics, Inc. (Nasdaq: SAGE) and Biogen Inc. (Nasdaq: BIIB) initiated a rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for zuranolone in the treatment of major depressive disorder (MDD). Zuranolone is an investigational two-week, once-daily oral drug being developed for MDD and postpartum depression (PPD). The companies have submitted the nonclinical module of the NDA to the FDA and plan to submit the remaining components for the MDD filing in the second half of 2022.

Sage Therapeutics, Inc. (Nasdaq: SAGE), a biopharmaceutical company leading the way to create a world with better brain health, announced today that it will host a live webcast on Tuesday, May 3, 2022 at 8:00 a.m. ET to announce first quarter 2022 financial results and discuss recent business updates.

Sage Therapeutics, Inc. (Nasdaq: SAGE), a biopharmaceutical company leading the way to create a world with better brain health, announced today the presentation of data from the Phase 2 LUMINARY Study that showed SAGE-718, a first-in-class, oral, positive allosteric modulator of the NMDA receptor, was generally well-tolerated and associated with improvement on multiple tests of executive performance and learning and memory in patients with mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease (AD). The LUMINARY Study is part of CogNEXT, Sage’s early-stage trial platform designed to evaluate the therapeutic potential of SAGE-718 to treat cognitive deficits across a range of brain health disorders. The data will be presented during the Emerging Science Session on Tuesday, April 5, at the 74th Annual Meeting of the American Academy of Neurology (AAN) in Seattle.

Sage Therapeutics, Inc. (Nasdaq: SAGE), a biopharmaceutical company leading the way to create a world with better brain health, announced today that the Company will give a presentation at the 2022 Stifel CNS Days on Tuesday, March 29, 2022 at 4:00pm ET.

Sage Therapeutics, Inc. (Nasdaq: SAGE), a biopharmaceutical company leading the way to create a world with better brain health, announced today the presentation of data that showed SAGE-718, a first-in-class, oral, positive allosteric modulator of the NMDA receptor, was associated with improvements on multiple tests of executive functioning and learning and memory in patients with mild cognitive impairment (MCI) due to Parkinson’s disease (PD) in the open label Phase 2 PARADIGM Study. The PARADIGM Study (Part A) is part of CogNEXT, Sage’s early-stage trial platform designed to evaluate the therapeutic potential of SAGE-718 to treat cognitive deficits across a range of brain health disorders. The data were presented as a virtual oral presentation at the AD/PD 2022 Advances in Science & Therapy International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurological Disorders taking place from March 15-20 both in-person in Barcelona, Spain, and virtually.

Sage Therapeutics, Inc. (Nasdaq: SAGE), a biopharmaceutical company fearlessly leading the way to create a world with better brain health, today reported business highlights and financial results for the fourth quarter and full year ended December 31, 2021.

Sage Therapeutics, Inc. (Nasdaq: SAGE), and Biogen Inc. (Nasdaq: BIIB) today announced the CORAL Study in people with major depressive disorder (MDD) met the trial objectives, demonstrating a rapid and statistically significant reduction in depressive symptoms at Day 3 and over the 2-week treatment period, achieving the primary and key secondary endpoints. This significance was demonstrated at the first measured time point, Day 3, with zuranolone 50 mg co-initiated with an open-label standard of care antidepressant (ADT) as assessed by change from baseline in the 17-item Hamilton Rating Scale for Depression (HAMD-17). The CORAL Study also met its key secondary endpoint, with zuranolone co-initiated with a standard of care ADT demonstrating a statistically significant improvement in depressive symptoms compared to ADT co-initiated with placebo, over the 2-week treatment period. Zuranolone was generally well-tolerated, and no new safety signals attributable to zuranolone were identified. In meeting its pre-defined objectives, the CORAL Study supports the potential of zuranolone, when co-initiated with standard of care, to accelerate the benefit of depression treatment compared to treatment with ADTs alone.

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 Thursday, February 24, 2022 at 8:00 a.m. ET to announce fourth quarter and full year 2021 financial results and discuss recent business updates.

Sage Therapeutics, Inc. (NASDAQSAGE), a biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with debilitating disorders of the brain, announced today that the Company will present at the 40th Annual J.P. Morgan Healthcare Conference on Tuesday, January 11, 2022 at 7:30am 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, will host its third annual “FutureCast: An R&D Portfolio Review” to showcase the Company’s research and development strategy, and clinical progress in its depression, neurology, and neuropsychiatry franchise programs.

Sage Therapeutics, Inc. (Nasdaq: SAGE) and Biogen Inc. (Nasdaq: BIIB) today announced new data from the LANDSCAPE clinical program evaluating the efficacy and safety of zuranolone for the treatment of major depressive disorder (MDD) presented at the American College of Neuropsychopharmacology (ACNP) Congress taking place December 5-8 in San Juan, Puerto Rico. Data from the SHORELINE and WATERFALL Studies in the LANDSCAPE clinical program further the understanding of the potential efficacy and safety profile of zuranolone for the treatment of MDD. Across the studies, zuranolone treatment led to improvements in depressive symptoms as well as in symptoms of elevated anxiety as assessed by multiple scales (HAMD-17, MADRS and HAM-A, respectively). In the WATERFALL Study, a rapid onset of effect in HAMD-17 was observed compared to placebo as early as Day 3, reaching statistical significance, followed by a stabilization of depressive symptoms through the follow-up period.

Sage Therapeutics, Inc. (Nasdaq: SAGE), and Biogen Inc. (Nasdaq: BIIB) today announced 12-month data for the cohort of patients (n=199), who received zuranolone 50 mg once nightly for 14-days as their initial dose in the ongoing Phase 3 open-label SHORELINE Study and had the opportunity to be followed for 12-months. The SHORELINE Study, part of the LANDSCAPE clinical program, was designed to naturalistically follow adult patients with major depressive disorder (MDD) and evaluate the safety and tolerability of zuranolone as well as the need for repeat dosing for up to one year. For the primary endpoint of safety and tolerability, the data analyzed to date show zuranolone was generally well-tolerated, with no new safety findings or trends identified in the long-term safety data available regardless of the number of courses of zuranolone a patient received. Zuranolone has consistently demonstrated rapid and sustained improvements in depressive symptoms and a well-tolerated safety profile throughout the LANDSCAPE clinical program.