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About Sage Therapeutics (NASDAQ: SAGE)
Sage Therapeutics is a clinical-stage biopharmaceutical company dedicated to transforming the treatment landscape for central nervous system (CNS) disorders. With a mission to improve the lives of patients suffering from life-threatening and rare CNS diseases, Sage Therapeutics focuses on discovering, developing, and delivering innovative medicines that address critical unmet medical needs. The company operates at the intersection of neuroscience and pharmacology, leveraging its expertise to advance a robust pipeline of therapies targeting CNS receptor systems, including GABA and NMDA.
Core Business Areas
Sage Therapeutics is primarily engaged in three key therapeutic areas:
- Depression: Developing groundbreaking treatments for major depressive disorder (MDD) and postpartum depression (PPD), including FDA-approved therapies like ZULRESSO and ZURZUVAE.
- Neurology: Addressing complex neurological conditions such as seizure disorders and cognitive impairments through innovative compounds.
- Neuropsychiatry: Advancing therapies for a range of psychiatric and cognitive disorders, with a focus on improving patient outcomes and quality of life.
Product Pipeline and Scientific Approach
Sage Therapeutics employs a science-driven approach to drug development, targeting CNS receptor systems that play a critical role in brain function. The company's proprietary chemistry platform has produced multiple compounds with preclinical and clinical activity, including:
- ZULRESSO (brexanolone): The first FDA-approved treatment for postpartum depression, administered as a CIV injection.
- ZURZUVAE (zuranolone): A novel oral medication for postpartum depression, reflecting Sage's commitment to patient-centric solutions.
- Investigational Therapies: SAGE-718 for cognitive disorders and SAGE-324 for essential tremor and other neurological conditions.
By targeting specific CNS pathways, Sage aims to address the underlying mechanisms of disease, offering patients therapies that are both effective and well-tolerated.
Industry Position and Competitive Landscape
Sage Therapeutics operates in the highly specialized and competitive biopharmaceutical sector, focusing on CNS disorders—a field with significant unmet medical needs. The company differentiates itself through its deep scientific expertise, robust clinical foundation, and strategic partnerships with leading academic institutions and industry players. Despite challenges such as regulatory approvals and competition from other CNS-focused companies, Sage's innovative pipeline and targeted approach position it as a key player in the neuroscience space.
Value Proposition
Sage Therapeutics delivers value by addressing critical gaps in CNS disorder treatments. Through its innovative therapies, the company aims to improve patient outcomes, reduce healthcare costs, and enhance quality of life for individuals affected by debilitating CNS conditions. Sage's commitment to rigorous science, clinical excellence, and patient-centric solutions underscores its role as a leader in advancing brain health medicines.
Conclusion
With a focus on neuroscience innovation, a robust pipeline of therapies, and a commitment to addressing unmet medical needs, Sage Therapeutics is at the forefront of transforming the treatment paradigm for CNS disorders. By leveraging its scientific expertise and strategic partnerships, the company continues to make significant strides in improving the lives of patients worldwide.
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.
Sage Therapeutics reported Q2 2022 results, highlighting progress on the rolling NDA submission for zuranolone aimed at treating major depressive disorder (MDD) and postpartum depression (PPD). The company announced positive topline data from the Phase 3 SKYLARK Study for PPD and is enrolling multiple Phase 2 studies across neuropsychiatry and neurology. Despite a net loss of $126.3 million, the company expects its financial position to support operations into 2025. Sage anticipates cash and marketable securities of approximately $1.3 billion by year-end 2022.
Sage Therapeutics (Nasdaq: SAGE) announced its participation in two upcoming investor conferences in August 2022. The company will hold a fireside chat at the Wedbush PacGrow Healthcare Conference on
Sage Therapeutics, Inc. (Nasdaq: SAGE) announced a live webcast on August 2, 2022, at 8:00 a.m. ET to disclose its second quarter 2022 financial results and discuss recent business updates. Investors can access the webcast via the company's investor page. A replay will be available for 30 days post-event.
Sage Therapeutics, a biopharmaceutical company focused on brain health, announced its participation in two key investor conferences in June 2022. The Jefferies Healthcare Conference will feature a fireside chat on June 8 at 11:30am ET in New York, while the Goldman Sachs Annual Global Healthcare Conference is set for June 13 at 3:20pm PT (6:20pm ET) in Palos Verdes, CA. Live webcasts of both events can be accessed on Sage's investor website, with replays available afterward for 30 days.
Sage Therapeutics and Biogen announced successful results from the Phase 3 SKYLARK Study of zuranolone, an oral treatment for postpartum depression (PPD). The study achieved its primary endpoint, showing a statistically significant improvement in depressive symptoms at Day 15 with a change from baseline HAMD-17 total score of -15.6 for zuranolone compared to -11.6 for placebo (p=0.0007). Additionally, safety profiles were consistent with previous studies. Zuranolone aims to provide rapid relief for the one in eight women affected by PPD in the U.S.
Sage Therapeutics (NASDAQ: SAGE) announced its participation in the Bank of America Securities 2022 Healthcare Conference, scheduled for May 11, 2022, at 8:00am PT (11:00am ET) in Las Vegas, NV. The presentation will be accessible via a live webcast on Sage's investor page. A replay will be available two hours post-event and archived for 30 days. Sage Therapeutics is committed to pioneering brain health solutions aimed at enhancing overall well-being. For further details, visit www.sagerx.com.
Sage Therapeutics reported Q1 2022 financial results, highlighting a net revenue of $1.6 million from ZULRESSO, unchanged from Q1 2021, while net loss widened to $122.1 million from $95.8 million.
R&D expenses increased to $78 million due to investments in pipeline programs, with cash reserves at $1.6 billion, projected to drop to $1.3 billion by year-end. Key updates include a rolling NDA submission for zuranolone in major depressive disorder and ongoing Phase 2 studies across neuropsychiatry and neurology franchises.
Sage Therapeutics and Biogen have initiated a rolling submission of a New Drug Application (NDA) for zuranolone to the FDA, targeting major depressive disorder (MDD). The nonclinical module has been submitted, with remaining components expected in H2 2022. Zuranolone is an investigational drug requiring a two-week daily regimen, and is also aimed at treating postpartum depression (PPD), with submissions planned for H1 2023. The drug has previously received Fast Track and Breakthrough Therapy Designations from the FDA, addressing unmet needs in depression treatment.
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