Welcome to our dedicated page for Sage Therapeutics news (Ticker: SAGE), a resource for investors and traders seeking the latest updates and insights on Sage Therapeutics stock.
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 will host a live webcast on May 2, 2023, at 8:00 a.m. ET to discuss its first quarter 2023 financial results and recent business updates. This event will be accessible via the Investor page on Sage’s website. A replay of the webcast will be available for 30 days post-event.
Sage Therapeutics focuses on advancing brain health solutions, committed to developing life-changing medicines for brain health. More information about their mission can be found on their website.
Sage Therapeutics (Nasdaq: SAGE), a biopharmaceutical company focused on brain health, announced its participation in the Stifel 2023 CNS Days on March 29, 2023, at 11:00 a.m. ET. The presentation will be available via live webcast on Sage's investor page. A replay will be accessible for 30 days following the event. Sage's mission is to develop transformative therapies for brain health, aiming to empower individuals to thrive. For more details, visit www.sagerx.com.
Sage Therapeutics, Inc. (NASDAQ: SAGE) has appointed Jessica Federer to its Board of Directors. With a strong background in digital health and innovation, Federer aims to enhance the company's growth in maternal mental health care. She previously served as the first Chief Digital Officer for Bayer AG, where she shaped global digital strategy. Federer expressed her commitment to redefining brain health treatment, highlighting the potential of data strategies in this area. CEO Barry Greene noted her patient-first approach aligns with Sage's core values and ambitions. This strategic appointment could drive future growth for the company.
Sage Therapeutics (SAGE) and Biogen (BIIB) announced that the FDA will not convene an advisory committee to discuss the New Drug Application for zuranolone, a treatment for major depressive disorder (MDD) and postpartum depression (PPD). This investigational drug has been granted priority review, with a Prescription Drug User Fee Act (PDUFA) action date set for August 5, 2023. Zuranolone is part of clinical programs LANDSCAPE and NEST, which include several studies across thousands of participants. The companies remain optimistic about zuranolone's potential, but there are inherent risks and uncertainties in drug approval processes.
Sage Therapeutics (NASDAQ: SAGE) will present at the Cowen 43rd Annual Health Care Conference on March 6, 2023, at 10:30 a.m. ET in Boston, MA. Investors can access the live webcast on Sage's investor page, with a replay available for 30 days after the event. Sage Therapeutics focuses on pioneering brain health solutions aimed at delivering transformative medicines, enhancing the quality of life for individuals. For further details, visit www.sagerx.com.
Sage Therapeutics, Inc. (Nasdaq: SAGE) announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation for SAGE-718, aimed at treating Huntington’s disease (HD). SAGE-718 is an oral therapy targeting cognitive disorders linked to NMDA receptor dysfunction, with ongoing Phase 2 and Phase 3 clinical studies in HD and other conditions like Parkinson’s disease and Alzheimer’s disease. The Orphan Drug Designation provides benefits such as market exclusivity for ten years upon approval, emphasizing Sage's commitment to address unmet medical needs in cognitive impairment.
Sage Therapeutics announces the FDA's acceptance of its New Drug Application for zuranolone, a treatment for Major Depressive Disorder (MDD) and Postpartum Depression (PPD), granted Priority Review with a PDUFA date of August 5, 2023. The company reported a year-end 2022 cash position of $1.3 billion, supporting operations until 2025. In clinical developments, positive data from the SKYLARK Study indicates zuranolone's potential, showing significant symptom improvement. Additionally, Sage's ongoing studies include SAGE-718 for cognitive disorders, with multiple Phase 2 trials advancing.
Sage Therapeutics (NASDAQ: SAGE) will host a live webcast on February 16, 2023, at 8:00 a.m. ET to discuss its fourth quarter and full year 2022 financial results along with recent business updates. The event will be accessible via the company's Investor page. A replay of the webcast will be available for up to 30 days post-event.
Sage Therapeutics announced progress in its brain health pipeline, including the submission of a rolling New Drug Application (NDA) for zuranolone to treat major depressive disorder (MDD) and postpartum depression (PPD). If approved, zuranolone could be the first oral treatment for these conditions. The company is advancing multiple studies for zuranolone and its other therapies, including SAGE-718, aiming for key milestones in 2023, such as a potential FDA decision on zuranolone. CEO Barry Greene emphasized urgency in developing innovative treatments for brain health disorders.
Sage Therapeutics, Inc. (NASDAQ: SAGE) announced its participation in the 41st Annual J.P. Morgan Healthcare Conference on January 10, 2023, at 10:30 a.m. PT in San Francisco, CA. The company aims to advance brain health through innovative biopharmaceutical solutions. Investors can access the live presentation via Sage's Investor page, and a replay will be available for 30 days post-event. Sage remains committed to pioneering life-changing brain health medicines, focusing on improving the lives of individuals.
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