Sage Therapeutics, Inc - SAGE STOCK NEWS

Sage Therapeutics (Nasdaq: SAGE) announced topline results from the Phase 2 LIGHTWAVE Study of dalzanemdor (SAGE-718) in treating mild cognitive impairment and mild dementia in Alzheimer's Disease. The study did not demonstrate a statistically significant difference from baseline in participants treated with dalzanemdor versus placebo on the primary endpoint, which was the WAIS-IV Coding Test score at Day 84.

Key points:

• Dalzanemdor was generally well-tolerated with no new safety signals observed
• The company does not plan further clinical development of dalzanemdor in Alzheimer's Disease
• Topline data from the Phase 2 DIMENSION Study of dalzanemdor in Huntington's Disease is expected later this year
• The study involved 174 randomized participants over 12 weeks
• No meaningful differences were observed in exploratory endpoints such as RBANS total score or MoCA total score

Sage Therapeutics announced that Biogen has terminated its rights to the SAGE-324 program following negative results from the Phase 2 KINETIC 2 Study for essential tremor treatment. The termination will be effective on February 17, 2025, with Sage resuming full ownership of the asset. Sage plans to evaluate other potential indications for SAGE-324.

Despite this, Sage and Biogen will continue their partnership on ZURZUVAE® (zuranolone), the first FDA-approved oral treatment for women with postpartum depression (PPD). The companies remain committed to their shared vision of helping women suffering from PPD.

The press release also includes important safety information for ZURZUVAE, highlighting potential side effects and precautions for its use.

The Schall Law Firm has announced a class action lawsuit against Sage Therapeutics, Inc. (NASDAQ:SAGE) for alleged violations of securities laws. Investors who purchased Sage securities between April 12, 2021, and July 23, 2024, are encouraged to join the lawsuit before October 28, 2024. The complaint alleges that Sage made false and misleading statements about the effectiveness of its drug Zuranolone for treating major depressive disorder (MDD) and SAGE-718 for mild cognitive impairment (MCI). The lawsuit claims that these misrepresentations led to investor losses when the truth about the drugs' efficacy and FDA approval likelihood was revealed.

Sage Therapeutics reported Q2 2024 financial results and pipeline updates. ZURZUVAE collaboration revenue reached $7.4 million, a 19% increase from Q1. Over 1,400 prescriptions were shipped, nearly doubling from Q1. Dalzanemdor (SAGE-718) topline data for Alzheimer's and Huntington's disease studies are expected in late 2024. The DIMENSION study's primary endpoint was adjusted to the Symbol Digit Modalities Test. SAGE-324 failed to meet the primary endpoint for essential tremor, leading to termination of the clinical program. Cash position stood at $647 million as of June 30, 2024. The company expects its current financial resources to support operations into 2026.

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.