Sage Therapeutics(US:SAGE) GlobeNewswire News Roomยท2024-09-20 20:18Core Viewpoint - Sage Therapeutics, Inc. is facing a class action lawsuit for alleged violations of the Securities Exchange Act of 1934, with claims that the company misled investors regarding the effectiveness and regulatory prospects of its drug candidates [1][4]. Company Overview - Sage Therapeutics is a biopharmaceutical company focused on developing brain health medicines, including zuranolone for postpartum depression and major depressive disorder, dalzanemdor for mild cognitive impairment due to Parkinson's Disease, and SAGE-324 for essential tremor [3]. Allegations of the Lawsuit - The lawsuit alleges that Sage Therapeutics made false statements about the effectiveness of zuranolone, dalzanemdor, and SAGE-324, leading investors to believe these drugs had better clinical and regulatory prospects than they actually did [4]. - Specific claims include that zuranolone was less effective for major depressive disorder than represented, and that the FDA was unlikely to approve its New Drug Application for this indication without further studies [4][5]. - The effectiveness of dalzanemdor for mild cognitive impairment was also overstated, as a Phase 2 study did not meet its primary endpoint, leading to a halt in its development [6]. - Similarly, SAGE-324's Phase 2 study for essential tremor failed to demonstrate significant results, resulting in the decision to cease further development [7][8]. Impact on Stock Price - Following the disclosure of the FDA's decision regarding zuranolone on August 4, 2023, Sage Therapeutics' stock price fell nearly 54% [5]. - The announcement regarding dalzanemdor on April 17, 2024, led to a nearly 20% drop in stock price [6]. - The news about SAGE-324 on July 24, 2024, resulted in a nearly 21% decline in stock price [8]. Legal Process - Investors who purchased Sage Therapeutics securities during the class period have until October 28, 2024, to seek appointment as lead plaintiff in the class action lawsuit [1][9].