AXSOME ALERT: Bragar Eagel & Squire, P.C. is Investigating Axsome Therapeutics, Inc. on Behalf of Long-Term Stockholders and Encourages Investors to Contact the Firm

Core Viewpoint - Bragar Eagel & Squire, P.C. is investigating potential claims against Axsome Therapeutics, Inc. regarding breaches of fiduciary duties by the board of directors following a class action complaint related to the company's AXS-07 New Drug Application (NDA) submission process [1] Company Overview - Axsome Therapeutics, Inc. is a biopharmaceutical company focused on developing novel therapies for central nervous system disorders in the United States [1] Product Development - The company is developing AXS-07, an investigational medicine for the acute treatment of migraine, which has shown positive results in two Phase 3 trials [2] Regulatory Issues - The preparation and submission of the AXS-07 NDA faced significant chemistry, manufacturing, and control (CMC) issues, which were not disclosed to investors [2][3] - The complaint alleges that Axsome's CMC practices were deficient, leading to delays in the NDA submission timeline and raising concerns about the likelihood of FDA approval [3] Stock Price Impact - Following the announcement of delays in the NDA submission on November 5, 2020, Axsome's stock price fell by $5.22 per share, or 6.99%, closing at $69.51 [4] - On April 25, 2022, after disclosing unresolved CMC issues identified by the FDA, the stock price dropped by $8.60 per share, or 21.99%, closing at $30.50 [5] - The receipt of a Complete Response Letter (CRL) from the FDA on May 2, 2022, further impacted the company's stock, as the CRL cited CMC considerations as the principal reasons for the FDA's decision [6]