Sage Therapeutics, Inc - SAGE STOCK NEWS

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.

Sage Therapeutics, Inc. (NASDAQ: SAGE) is set to host a live webcast on May 3, 2022, at 8:00 a.m. ET, to present first quarter financial results and discuss recent business updates. Investors can access the webcast via the company's investor page. A replay will be available two hours post-event and archived for 30 days. Sage remains dedicated to pioneering solutions for brain health.

Sage Therapeutics presented data from its Phase 2 LUMINARY Study at the American Academy of Neurology’s Annual Meeting. The study evaluated SAGE-718, an oral positive allosteric modulator, for mild cognitive impairment and mild dementia due to Alzheimer’s disease. Results showed significant improvements in executive function and memory tests among 26 patients. SAGE-718 demonstrated a statistically significant increase in the Montreal Cognitive Assessment score. The treatment was generally well-tolerated, with no serious adverse events reported.

Sage Therapeutics will present at the 2022 Stifel CNS Days on March 29, 2022, at 4:00 PM ET. The presentation can be accessed via a live webcast on Sage's investor page, with a replay available two hours post-event for 30 days. Sage Therapeutics focuses on developing innovative therapies to improve brain health, particularly in depression and neurological disorders. The company's mission is to create impactful medicines for better patient outcomes. For more details, visit www.sagerx.com.

Sage Therapeutics presented data at the AD/PD 2022 conference revealing that SAGE-718, an oral drug for mild cognitive impairment due to Parkinson's disease, showed promising results. The Phase 2 PARADIGM Study indicated improved cognitive performance in eleven patients, particularly in executive functioning and memory tests. SAGE-718 was well tolerated with no serious adverse events reported. The study highlights the potential for SAGE-718 to address significant cognitive deficits faced by up to 50% of Parkinson's patients.

Sage Therapeutics, Inc. (NASDAQ: SAGE) will participate in a fireside chat at the Cowen 42nd Annual Healthcare Conference on March 7, 2022, at 10:30 AM ET. A live webcast of the event will be available on the investor page of Sage's website and can be replayed approximately two hours post-event, archived for 30 days. Sage Therapeutics focuses on developing innovative therapies aimed at transforming brain health. For more information, visit www.sagerx.com.

Sage Therapeutics (SAGE) reported its 2021 financial results, revealing a net loss of $457.9 million compared to a profit of $606.1 million in 2020. Cash and cash equivalents are projected to decrease to $1.3 billion by the end of 2022. Sage plans to initiate a rolling NDA for zuranolone in major depressive disorder (MDD) and anticipates a filing for postpartum depression (PPD) in 2023. Key clinical studies showcased positive results for zuranolone in treating MDD and PPD, supporting its potential as a rapid-acting treatment. R&D expenses decreased to $283.2 million, while SG&A expenses were $183.5 million for the year.

Sage Therapeutics and Biogen announced that their CORAL Study achieved both primary and secondary endpoints in treating major depressive disorder (MDD) with zuranolone 50 mg. The trial demonstrated a statistically significant reduction in depressive symptoms at Day 3 and over a 2-week period compared to placebo. Participants reported adverse effects mostly mild or moderate, with no new safety signals. The results suggest zuranolone may accelerate the efficacy of existing antidepressants. A conference call will discuss the findings further.