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Case Page

 

Case Status:    ONGOING  
—On or around 07/07/2025 (Date of last review)
Current/Last Presiding Judge:  
Hon. William Q. Hayes

Filing Date: April 19, 2021

According to the Complaint, Acadia Pharmaceuticals Inc. 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 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 Complaint alleges that throughout the Class Period, Defendants made materially false and misleading statements regarding the Company's business. Specifically, the Complaint alleges 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 September 29, 2021, the Court issued an Order appointing Lead Plaintiff and Counsel. Lead Plaintiff filed an amended Complaint on December 10. Defendants filed a Motion to Dismiss the amended Complaint on February 15, 2022. On September 27, the Court issued an Order denying Defendants' Motion to Dismiss.

Lead Plaintiff filed a Motion for Class Certification on August 21, 2023. On March 11, 2024, the Court issued an Order granting Plaintiff's Motion for Class Certification.

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