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Acadia Pharmaceuticals Inc.

Case Details

Class Period: June 15, 2020 - April 4, 2021
Date Filed: April 19, 2021
Case Number: 3:21cv00762
Jurisdiction: California Southern District Court
icon-casetype Case Type: Securities Case
Days Left to
Seek Plaintiff:
36

Case Summary

Acadia is a biopharmaceutical company that focuses on the development and commercialization of small molecule drugs that address unmet medical needs in central nervous system disorders. The Company is developing pimavanserin as a treatment for dementia-related psychosis and as an adjunctive treatment for schizophrenia, as well as an adjunctive treatment for major depressive disorder. In April 2016, the U.S. Food and Drug Administration (“FDA”) approved pimavanserin for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis. In June 2020, Acadia submitted a supplemental New Drug Application (“sNDA”) with the FDA to expand pimavanserin’s label to include treatment for dementia-related psychosis (the “pimavanserin sNDA”). The complaint alleges that throughout the Class Period, Defendants made materially false and misleading statements regarding the Company’s business. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) the materials submitted in support of the pimavanserin sNDA contained statistical and design deficiencies; (ii) accordingly, the pimavanserin sNDA lacked the evidentiary support that the Company had led investors to believe it possessed; (iii) the FDA was unlikely to approve the pimavanserin sNDA in its present form; and (iv) as a result, the Company’s public statements were materially false and misleading at all relevant times. On March 8, 2021, post-market, 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 Company’s [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, Acadia’s 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, pre-market, 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, Acadia’s stock price fell $4.41 per share, or 17.23%, to close at $21.18 per share on April 5, 2021.

Documents
Complaint