Welcome to our dedicated page for Sage Therapeutic news (Ticker: SAGE), a resource for investors and traders seeking the latest updates and insights on Sage Therapeutic stock.
Sage Therapeutics, Inc. (former Nasdaq: SAGE) is a Cambridge, Massachusetts-based biopharmaceutical company focused on brain health, with a particular emphasis on postpartum depression. The company reports that it developed the only two FDA-approved treatments indicated for postpartum depression and highlights ZURZUVAE (zuranolone), described as the first-and-only oral treatment for adults with postpartum depression and, in some communications, as a once-daily 14-day oral treatment.
The news flow around Sage has centered on several themes. One major area is commercial updates for ZURZUVAE, including collaboration revenue recognized under its agreement with Biogen, prescription shipment trends for women with postpartum depression, prescriber behavior among obstetrician-gynecologists, and payer coverage metrics. Regular quarterly earnings releases have discussed revenue from ZURZUVAE, other collaboration revenue, research and development spending, selling, general and administrative expenses, restructuring charges, and cash runway expectations.
Another recurring topic is Sage’s research and development pipeline. Company news has described progress with SAGE-319, an extrasynaptic-preferring GABAA receptor positive allosteric modulator being studied for behavioral symptoms associated with certain neurodevelopmental disorders, along with preclinical NMDA receptor negative allosteric modulator programs SAGE-817 and SAGE-039, and evaluation of potential indications for SAGE-324, including seizures in developmental and epileptic encephalopathies.
Corporate and strategic developments are also prominent in Sage’s news. Releases have covered a strategic alternatives review, unsolicited acquisition proposals, and, ultimately, the definitive agreement and subsequent completion of an acquisition by Supernus Pharmaceuticals, Inc. Investors reviewing SAGE-related news can use this page to follow historical earnings announcements, pipeline updates, leadership changes, strategic reviews, and the steps that led to Sage becoming a wholly owned subsidiary of Supernus.
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.
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.