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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 disappointing topline results from their Phase 2 KINETIC 2 study of SAGE-324 (BIIB124) for treating essential tremor (ET). The study failed to demonstrate a statistically significant dose-response relationship or any significant differences between SAGE-324 doses and placebo in reducing tremor severity. Key findings include:
- No statistically significant improvements in the primary endpoint (TETRAS Performance Subscale Item 4 total score) or secondary endpoint (TETRAS Activities of Daily Living Composite Score)
- 147 participants were randomized to placebo, 15 mg, 30 mg, or 60 mg doses
- Common side effects included somnolence, dizziness, and fatigue
- Dose-related increases in CNS depressant side effects were observed
As a result, Sage and Biogen will discontinue further clinical development of SAGE-324 for essential tremor.
Sage Therapeutics (NASDAQ: SAGE), a biopharmaceutical company focused on brain health, has announced it will host a live webcast on Wednesday, July 31, 2024, at 4:30 p.m. ET. The webcast will cover the company's second quarter 2024 financial results and provide updates on recent business activities. Investors and interested parties can access the webcast through the Investor page on Sage's website at investor.sagerx.com. A replay of the webcast will be available after the event and archived for up to 30 days.
Sage Therapeutics announced topline results from its Phase 2 SURVEYOR Study for Huntington's Disease (HD). The study met its primary endpoint, highlighting a significant cognitive difference between healthy participants and those with HD, as measured by the HD-Cognitive Assessment Battery (HD-CAB).
Dalzanemdor (SAGE-718) was generally well-tolerated, with no new safety signals observed. The study involved 40 participants with HD and 29 healthy controls. While the study wasn't designed to show a significant difference between dalzanemdor and placebo, a small numerical improvement was noted in cognition for those on dalzanemdor.
Sage plans to apply these findings to future research and expects to report further data from the dalzanemdor program in late 2024, including studies on Alzheimer's Disease and additional HD cognitive impairment.
Sage Therapeutics (NASDAQ: SAGE), a biopharmaceutical company focused on brain health, announced its participation in the Goldman Sachs 45th Annual Global Healthcare Conference. The event will include a fireside chat scheduled for June 12, 2024, at 2:00 p.m. ET in Miami, FL. Interested parties can view a live webcast of the presentation on Sage's Investor page. A replay will be available for 30 days post-event.
Sage Therapeutics, a biopharmaceutical company, will participate in investor conferences in May, including the 2024 RBCCM Global Healthcare Conference and BofA Securities 2024 Health Care Conference. The Company aims to create a world with better brain health. Live webcasts and replays of the presentations will be available on Sage's Investor page.
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