Acadia Pharmaceuticals Inc.
The law firm of Kirby McInerney LLP announces that a class action lawsuit has been filed in the U.S. District Court for the Southern District of California on behalf of those who acquired Acadia Pharmaceuticals Inc (“Acadia” or the “Company”) (NASDAQ: ACAD) securities during the period from June 15, 2020 through April 4, 2021 (the “Class Period”). Investors have until June 18, 2021 to apply to the Court to be appointed as lead plaintiff in the lawsuit.
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").
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.
If you acquired Acadia securities, have information, or would like to learn more about these claims, please contact Thomas W. Elrod of Kirby McInerney at 212-371-6600, by email at firstname.lastname@example.org, or by filling out this contact form, to discuss your rights or interests with respect to these matters without any cost to you.