Acadia is a biopharmaceutical company that develops a drug called 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 U.S. Food and Drug Administration (“FDA”) to expand pimavanserin’s label to include treatment for dementia-related psychosis.
On March 8, 2021, the Company revealed that, as part of its ongoing review of the sNDA, the FDA “has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments 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, thereby injuring investors.
On April 5, 2021, pre-market, the Company disclosed receipt of 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 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, thereby injuring investors further.
The complaint filed in this class action alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants failed to disclose to investors 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, Defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis at all relevant times.
If you purchased Acadia securities during the Class Period, you may move the Court no later than June 18, 2021 to ask the Court to appoint you as lead plaintiff. To be a member of the Class you need not take any action at this time; you may retain counsel of your choice or take no action and remain an absent member of the Class. If you purchased Acadia securities, have information or would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Frank R. Cruz, of The Law Offices of Frank R. Cruz, 1999 Avenue of the Stars, Suite 1100, Los Angeles, California 90067 at 310-914-5007, by email to email@example.com, or visit our website at www.frankcruzlaw.com. If you inquire by email please include your mailing address, telephone number, and number of shares purchased.