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Sage Therapeutics, Inc. (SAGE) is a pioneering, neuroscience-focused biopharmaceutical company dedicated to developing medicines for life-threatening and rare central nervous system (CNS) disorders. Founded in 2010, Sage Therapeutics aims to improve the lives of patients suffering from various CNS diseases through breakthrough scientific research, robust clinical trials, and strong partnerships.
The company is primarily engaged in three key focus areas: depression, neurology, and neuropsychiatry. Sage's lead compound, SAGE-547, is in clinical development for super-refractory status epilepticus (SRSE), marking the first of many potential seizure medicines in its extensive pipeline. Another notable treatment, Zurzuvae, targets postpartum depression (PPD) in adults, while Zulresso is a CIV injection designed for individuals aged 15 and older dealing with PPD.
In addition to these approved treatments, the company’s pipeline features several promising compounds, including SAGE-324 and Dalzanemdor (SAGE-718), which are currently under various stages of development. Sage Therapeutics leverages two critical CNS receptor systems, GABA and NMDA, to develop its innovative treatments.
Sage’s commitment to compelling science and robust clinical foundations is fortified by its world-class team of founders, advisors, investors, scientists, and managers. The company prides itself on its collaborative efforts, fostering strategic partnerships to enhance its research and development capabilities. These efforts underscore Sage Therapeutics' mission to discover, develop, and deliver significant new medicines to address unmet medical needs in the CNS space.
Sage Therapeutics and Biogen have completed the NDA submission for zuranolone, a rapid-acting oral treatment for major depressive disorder (MDD) and postpartum depression (PPD). This 14-day treatment aims to provide quicker symptom relief compared to existing therapies. The NDA integrates data from the LANDSCAPE and NEST programs, which included multiple studies in adults with MDD and women with PPD. Zuranolone has received Fast Track and Breakthrough Therapy designations by the FDA, indicating its potential significance in treating depression.
Sage Therapeutics, a biopharmaceutical company focused on brain health, will present at the Piper Sandler 34th Annual Healthcare Conference on December 1, 2022, at 8:00 a.m. ET in New York, NY. A live webcast of the presentation will be accessible via the company's Investor page, with a replay available for 30 days post-event. Sage aims to pioneer solutions for life-changing brain health medicines to help individuals thrive.
Sage Therapeutics and Biogen will host a joint investor webcast on December 6 at 8:00 a.m. ET to discuss commercialization strategies for zuranolone, their investigational treatment for major depressive disorder and postpartum depression. The webcast will address the clinical data of zuranolone and the unmet need in these conditions. Investors can access the live webcast on both companies' investor webpages and it will be available for up to 30 days post-event.
Sage Therapeutics, a biopharmaceutical company focused on brain health, will present at the Stifel 2022 Healthcare Conference on November 16, 2022, at 10:55 a.m. ET in New York, NY. Investors can access a live webcast of the presentation on the Investor page of Sage's website. A replay will be available for up to 30 days post-event. Sage's mission is to pioneer solutions for brain health, aiming to create life-changing medicines that help individuals thrive.
Sage Therapeutics reported Q3 2022 results, showcasing significant advancements in its pipeline. The company is on track to complete the NDA submission for zuranolone for MDD and PPD by December 2022. Key leadership appointments, including Dr. Laura Gault as Chief Medical Officer, aim to strengthen its position in brain health. Financially, Sage ended Q3 with $1.4 billion in cash but reported a net loss of $137.3 million. Revenue from ZULRESSO grew to $1.7 million. Sage anticipates cash will support operations into 2025, despite projected increases in R&D and SG&A expenses.
Sage Therapeutics (NASDAQ: SAGE) has appointed Dr. Laura Gault as Chief Medical Officer. Dr. Gault brings over 15 years of experience in the pharmaceutical industry, having worked on development programs in neuropsychiatry and neuroinflammation. Her previous roles include Vice President at Alexion/AstraZeneca, where she contributed to significant drug developments. In her new position, Dr. Gault will focus on advancing Sage's product pipeline, driven by a commitment to improve brain health treatment options.
Sage Therapeutics (Nasdaq: SAGE) announced a live webcast on November 8, 2022, at 8:00 a.m. ET to discuss its third quarter 2022 financial results and recent business updates. The webcast will be accessible via the Investor page on Sage's website, with a replay available for 30 days post-event. Sage Therapeutics is focused on developing innovative solutions for brain health, aiming to deliver impactful medicines to enhance the quality of life.
Zuranolone 50 mg has shown improvement in depressive symptoms by Day 15 in the SKYLARK Study, with statistically significant results also at Days 3, 28, and 45. The study, presented at the ECNP Congress, highlighted the drug's rapid effect in women suffering from postpartum depression (PPD). Zuranolone was well-tolerated, with mild to moderate treatment-emergent adverse events. A New Drug Application (NDA) submission to the FDA for zuranolone is underway, aiming for completion in late 2022.
Sage Therapeutics and Biogen present new analyses on zuranolone, an investigational treatment for major depressive disorder (MDD) and postpartum depression (PPD), at Psych Congress in New Orleans from September 17 to 20, 2022. Key findings from the SHORELINE Study show a median of 135 days for repeat treatment in the 30 mg cohort. Results indicate sustained improvements in MDD symptoms and a favorable safety profile. Zuranolone is being evaluated under Fast Track and Breakthrough Therapy Designations by the FDA.
Sage Therapeutics, Inc. (Nasdaq: SAGE) has announced its presentation at the Morgan Stanley 20th Annual Global Healthcare Conference on September 12, 2022, at 3:40 p.m. ET in New York, NY. Investors can access a live webcast on the Company’s investor page, with a replay available two hours post-event and archived for 30 days. Sage Therapeutics focuses on pioneering solutions for brain health medicines, aiming to enhance the quality of life for individuals.