Cases & investigations

Cases & investigations

Acadia Pharmaceuticals

Kaskela Law LLC announces that a shareholder class action lawsuit has been filed against Acadia Pharmaceuticals Inc. (“Acadia”) (NASDAQ: ACAD) on behalf of certain investors who purchased shares of the Company’s stock between September 9, 2019 and April 4, 2021.

As detailed in the complaint, Acadia is a biopharmaceutical company that focuses on the development and commercialization of small molecule drugs that seek to address unmet medical needs in central nervous system disorders. The company’s most valuable drug from a commercial perspective is pimavanserin, which Acadia touts as a treatment for dementia-related psychosis (“DRP”).

According to the complaint, between September 9, 2019 and April 4, 2021, Acadia and certain of the company’s senior executive officers issued a series of false and misleading statements concerning Acadia’s HARMONY trial, which had been designed to study the greatly expanded use of pimavanserin.

On March 8, 2021, Acadia disclosed that it “received a notification from the U.S. Food and Drug Administration (FDA) on March 3, 2021, stating that, as part of its ongoing review of the Company’s supplemental New Drug Application (sNDA), the FDA has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time.”  Following this news, shares of Acadia’s common stock fell $20.76 per share, or over 45% in value, to close on March 9, 2021 at $25.02 per share, on heavy trading volume.

Then, on April 5, 2021, Acadia disclosed that it had received a Complete Response Letter (CRL) from the FDA regarding the sNDA “to indicate that they have completed their review of the application and has determined that the application cannot be approved in its present form.”  The press release further disclosed 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.”  Following this additional news, shares of Acadia’s common stock fell an additional $4.41 per share, or over 17% in value, to close on April 5, 2021 at $21.18 per share, again on heavy trading volume.

Current Acadia stockholders who purchased or acquired shares of the company’s common stock prior to September 9, 2019 are encouraged to contact Kaskela Law LLC (D. Seamus Kaskela, Esq. or Adrienne Bell, Esq.) at (484) 229 – 0750, or by completing the form on this page, for additional information about this investigation and their legal rights and options.

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