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Sage Therapeutics reports developments tied to its brain-health biopharmaceutical business, including commercialization updates for ZURZUVAE® (zuranolone), an FDA-approved oral treatment indicated for adults with postpartum depression. Company news has also covered collaboration revenue, shipment trends, disease-awareness initiatives, and financial results connected to the postpartum depression market.
Recurring updates also address Sage’s pipeline and corporate matters, including SAGE-319, an extrasynaptic-preferring GABAA receptor positive allosteric modulator being investigated for behavioral symptoms associated with certain neurodevelopmental disorders, early discovery work within its NMDA NAMs platform, governance changes, strategic-review activity, and public-company status changes.
Sage Therapeutics and Biogen announced plans to submit a New Drug Application (NDA) for the investigational drug zuranolone aimed at treating Major Depressive Disorder (MDD) in the second half of 2022. Following successful discussions with the FDA, their filing will include data from key clinical studies. A subsequent NDA for Postpartum Depression (PPD) is anticipated in early 2023. Both companies aim to launch marketing for zuranolone upon FDA approval, presenting a potential solution for millions suffering from depression worldwide.
Sage Therapeutics and Biogen announced promising data from their clinical programs for zuranolone, targeting major depressive disorder (MDD) and postpartum depression (PPD). Results from the Phase 3 WATERFALL Study showed significant reductions in depressive symptoms, with improvements observed as early as Day 3. Safety profiles were favorable, showing no common side effects linked to current antidepressants. A conference call is scheduled for October 4, 2021, to discuss findings presented at the ECNP Congress.
Sage Therapeutics (SAGE) has launched SageCitizen, a corporate social impact initiative aimed at enhancing its commitment to People, Patients, Planet, and Community. The program encourages employee volunteerism with over 200 Sage employees participating in various community service activities. These efforts include packing emergency aid bags for children, building beds for homeless children, and providing menstrual products for low-income women. SageCitizen aims to deepen relationships with community partners and enhance the well-being of its stakeholders while formalizing the company’s existing philanthropic efforts.
Sage Therapeutics (NASDAQ: SAGE) has appointed Chris Benecchi as Chief Commercial Officer to lead global commercial efforts across all programs. Benecchi's background includes leadership roles at Alexion and UCB, focusing on commercial strategy and product launches. His responsibilities include developing commercialization strategies for the company's pipeline, especially zuranolone, which is in Phase 3 development for major depressive disorder and postpartum depression. CEO Barry Greene expressed confidence in Benecchi’s ability to drive successful commercialization and enhance Sage’s position in the market.
Sage Therapeutics (SAGE) announced that the FDA has granted Fast Track Designation for its drug SAGE-718, aimed at treating Huntington’s disease (HD). This designation is intended to accelerate the development and review of therapies for serious conditions with unmet needs. Cognitive decline is a significant concern in HD. The company believes that SAGE-718 could improve cognitive function, evidenced by previous studies. Fast Track status allows for increased interaction with the FDA to expedite regulatory review and development processes.
Sage Therapeutics, a biopharmaceutical company focused on transforming brain health, will participate in the Morgan Stanley Global Healthcare Conference on September 10 at 12:30 PM ET. Investors can access a live webcast of the event on Sage's investor page. The webcast will be available for replay approximately two hours after the event and archived for 30 days. Sage aims to develop innovative therapies to address debilitating brain disorders, underscoring its mission to create impactful medicines.
Sage Therapeutics (NASDAQ: SAGE) will participate in two upcoming investor conferences in August 2021. Barry Greene, CEO, will speak at the Wedbush PacGrow Healthcare Virtual Conference on August 10 at 12:00 p.m. ET, discussing novel neuro approaches. The company will also hold a fireside chat at the Canaccord Genuity 41st Annual Growth Conference on August 11 at 8:00 a.m. ET. Investors can access live webcasts through the investor page on Sage's website, with replays available for 30 days.
Sage Therapeutics (Nasdaq: SAGE) reported its Q2 2021 financial results, highlighting a net loss of $107.2 million, an improvement from a net loss of $136.3 million in Q2 2020. The cash position stands at $1.9 billion, down from $2.0 billion in Q1 2021. Revenue from ZULRESSO increased to $1.6 million, up from $1.1 million year-over-year. Significant advancements were made in their pipeline, particularly zuranolone, which met primary endpoints in the WATERFALL Study for major depressive disorder. Sage anticipates over $1.7 billion in cash reserves by the end of 2021.
Sage Therapeutics, a Nasdaq-listed biopharmaceutical company focused on developing treatments for brain disorders, will host a live webcast on August 3, 2021, at 8:00 a.m. ET. The session aims to announce the company’s second quarter 2021 financial results and highlight recent business developments. Investors can access the webcast on Sage's investor page. A replay will be available two hours post-event, archived for up to 30 days. Sage continues its mission of innovating therapies to enhance brain health and transform treatments for depression and neurological disorders.
Sage Therapeutics, Inc. (NASDAQ: SAGE) has announced its participation in a fireside chat at Cowen’s Psychedelics & Novel Mechanisms in Neuropsychiatry Summit on July 13 at 2:25 PM ET. This event is part of the company's ongoing commitment to develop novel therapies for brain disorders. A live webcast of the presentation will be available on Sage's investor page, with an archived replay accessible for 30 days post-event. Sage aims to transform the treatment of debilitating brain disorders through innovative approaches in neurology and neuropsychiatry.