GlobeNewswire Inc | Apr 20, 2021 06:08PM EDT

April 20, 2021

NEW YORK, April 20, 2021 (GLOBE NEWSWIRE) -- Gainey McKenna & Egleston announces that a class action lawsuit has been filed against Acadia Pharmaceuticals Inc. (Acadia or the Company) (NASDAQ: ACAD) in the United States District Court for the Southern District of California on behalf of those who purchased or acquired the securities of Acadia between June 15, 2020 and April 4, 2021, inclusive (the Class Period). The lawsuit seeks to recover damages for investors under the federal securities laws.

The Complaint alleges that Defendants made false and/or misleading statements and/or failed to disclose that: (1) the materials submitted in support of the pimavanserin sNDA contained statistical and design deficiencies; (2) accordingly, the pimavanserin sNDA lacked the evidentiary support that the Company had led investors to believe it possessed; (3) the FDA was unlikely to approve the pimavanserin sNDA in its present form; and (4) as a result, the Companys public statements were materially false and misleading at all relevant times.

On March 8, 2021, Acadia issued a press release providing a regulatory update on the pimavanserin sNDA, disclosing that the Company received a notification from the [FDA] on March 3, 2021, stating that, as part of its ongoing review of the Companys [sNDA], the FDA has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time. Acadia advised that [t]he notification does not specify the deficiencies identified by the FDA and there has been no clarification by the FDA at this time. On this news, Acadias stock price fell $20.76 per share, or 45.35%, to close at $25.02 per share on March 9, 2021.

Then, on April 5, 2021, Acadia issued a press release announcing that the Company had received a Complete Response Letter (CRL) from the FDA indicating that the pimavanserin sNDA could not be approved in its current form. Specifically, the press release stated that the [FDA Division of Psychiatry], in the CRL, cited a lack of statistical significance in some of the subgroups of dementia, and insufficient numbers of patients with certain less common dementia subtypes as lack of substantial evidence of effectiveness to support approval. On this news, Acadias stock price fell $4.41 per share, or 17.23%, to close at $21.18 per share on April 5, 2021.

Investors who purchased or otherwise acquired shares of Acadia during the Class Period should contact the Firm prior to the June 18, 2021 lead plaintiff motion deadline. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. If you wish to discuss your rights or interests regarding this class action, please contact Thomas J. McKenna, Esq. or Gregory M. Egleston, Esq. of Gainey McKenna & Egleston at (212) 983-1300, or via e-mail at tjmckenna@gme-law.com or gegleston@gme-law.com.

Please visit our website at http://www.gme-law.com for more information about the firm.