NEW YORK, May 18, 2022 (GLOBE NEWSWIRE) -- Wolf Haldenstein Adler Freeman & Herz LLP announces that a federal securities class action lawsuit has been filed in the United States District Court for the Southern District of New York behalf of persons and entities that purchased or otherwise acquired Axsome Therapeutics, Inc. (“Axsome” or the “Company”) (NASDAQ: AXSM). The class action is on behalf of a class consisting of those who acquired Axsome securities between December 30, 2019 and April 22, 2022, both dates inclusive (the “Class Period”).
All investors who purchased the shares of Axsome Therapeutics, Inc. and incurred losses are advised to contact the firm immediately at classmember@whafh.com or (800) 575-0735 or (212) 545-4774. You may obtain additional information concerning the action or join the case on our website, www.whafh.com.
If you have incurred losses in Axsome Therapeutics, Inc. you may, no later than July 12, 2022, request that the Court appoint you lead plaintiff of the proposed class. Please contact Wolf Haldenstein to learn more about your rights as an investor in Axsome Therapeutics, Inc.
PLEASE CLICK HERE TO JOIN THE CASE
The filed complaint alleges that, throughout the Class Period, Defendants made materially false and misleading statements regarding the Company’s business, operations, and prospects. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that:
- Axsome’s CMC practices were deficient with respect to AXS-07 and its manufacturing process;
- as a result, Axsome was unlikely to submit the AXS-07 NDA on its initially represented timeline;
- the foregoing CMC issues remained unresolved at the time that the FDA reviewed the AXS-07 NDA;
- accordingly, the FDA was unlikely to approve the AXS-07 NDA;
- as a result of all the foregoing, Axsome had overstated AXS-07’s regulatory and commercial prospects; and
- as a result, the Company’s public statements were materially false and misleading at all relevant times.
On November 5, 2020, Axsome issued a press release reporting the Company’s third quarter 2020 results. That press release disclosed that the Company “plans to submit the [AXS-07] NDA to the FDA in the first quarter of 2021, versus previous guidance of the fourth quarter of 2020, to allow for inclusion of supplemental manufacturing information to ensure a robust submission package.”
On this news, Axsome’s stock price fell $5.22 per share, or 6.99%, to close at $69.51 per share on November 5, 2020.
Then, on April 25, 2022, Axsome disclosed in a filing with the U.S. Securities and Exchange Commission that, “[o]n April 22, 2022, Axsome . . . was informed by the [FDA] that [CMC] issues identified during the FDA’s review of the Company’s [NDA] for its AXS-07 product candidate for the acute treatment of migraine are unresolved.” That filing also disclosed that “[b]ased upon the time remaining in the NDA review cycle, the Company expects to receive a Complete Response Letter [(‘CRL’)] with respect to this NDA on or about the Prescription Drug User Fee Act target action date of April 30, 2022.”
On this news, Axsome’s stock price fell $8.60 per share, or 21.99%, to close at $30.50 per share on April 25, 2022.
has extensive experience in the prosecution of securities class actions and derivative litigation in state and federal trial and appellate courts across the country. The firm has attorneys in various practice areas; and offices in New York, Chicago and San Diego. The reputation and expertise of this firm in shareholder and other class litigation has been repeatedly recognized by the courts, which have appointed it to major positions in complex securities multi-district and consolidated litigation.
If you wish to discuss this action or have any questions regarding your rights and interests in this case, please immediately contact Wolf Haldenstein by telephone at (800) 575-0735 or via e-mail at classmember@whafh.com
Contact:
Wolf Haldenstein Adler Freeman & Herz LLP
Patrick Donovan, Esq.
Gregory Stone, Director of Case and Financial Analysis
Email: gstone@whafh.com, donovan@whafh.com or classmember@whafh.com
Tel: (800) 575-0735 or (212) 545-4774
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