Sage Therapeutics, Inc - SAGE STOCK NEWS

Sage Therapeutics (SAGE) announced that its Phase 2 DIMENSION Study of dalzanemdor (SAGE-718) for cognitive impairment in Huntington's Disease failed to meet its primary endpoint. The study showed no statistically significant difference versus placebo in the Symbol Digit Modalities Test at Day 84. Secondary endpoints also failed to demonstrate meaningful differences between treatment groups. While the drug was generally well-tolerated with no new safety concerns, the company has decided to discontinue further development of dalzanemdor and will close the ongoing PURVIEW Study.

Sage Therapeutics reported Q3 2024 financial results, highlighting $11 million in ZURZUVAE collaboration revenue, a 49% increase from Q2. The company announced it will not pursue zuranolone development for major depressive disorder in the US, focusing instead on postpartum depression treatment. Key metrics include approximately 2,000 prescriptions shipped in Q3 (40% increase from Q2), with over 90% commercial and Medicaid coverage. Cash position stood at $569 million as of September 30. The company plans to discontinue ZULRESSO by December 31, 2024, and expects current funds to support operations into 2026.

Sage Therapeutics has announced a strategic reorganization to support the launch of ZURZUVAE for postpartum depression and focus on pipeline development. The plan includes a workforce reduction of approximately 33%, affecting over 165 employees. This restructuring aims to extend the company's cash runway and position it for long-term growth.

Key changes include:

• Leadership team changes with several executives departing
• Chris Benecchi expanding role to Chief Operating Officer
• Greg Shiferman promoted to Senior VP, General Counsel
• Vanessa Procter taking on expanded responsibilities

The reorganization is expected to be completed by Q4 2024, with an anticipated non-recurring charge of $26-28 million. Sage will provide updated cash runway guidance soon.

Sage Therapeutics, Inc. (NASDAQ: SAGE) has announced that it will host a live webcast on Tuesday, October 29, 2024, at 4:30 p.m. ET. The purpose of this webcast is to review the company's third quarter 2024 financial results and provide updates on recent business activities. Investors and interested parties can access the webcast through the Investor page of Sage's website at investor.sagerx.com. For those unable to attend the live event, a replay will be made available and archived for up to 30 days following the webcast's completion.

Talkiatry, a leading provider of in-network psychiatric care, has announced a new pathway for postpartum depression (PPD) support. This initiative aims to improve access to care for women experiencing postpartum mental health challenges through virtual appointments with board-certified psychiatrists. The company has launched new educational resources to help women identify PPD symptoms and schedule virtual consultations if needed.

Approximately one in eight new mothers in the United States report experiencing PPD symptoms. Despite its prevalence, access to timely care remains challenging due to a shortage of psychiatrists and long wait times. Talkiatry's telehealth alternative, developed in partnership with Biogen Inc. (Nasdaq: BIIB), aims to address these gaps in maternal mental healthcare.

The new PPD page on Talkiatry's website offers educational information, an online assessment tool, and a scheduling system for appointments with psychiatrists. Talkiatry provides virtual psychiatry and therapy covered by over 60 health insurance plans across 43 states, with new patients seen within days of making an appointment.

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.