The Newsroom

Investigations  /  04.23.2021

Investigation of Acadia Pharmaceuticals Inc.

You Have Legal Options

Acadia Pharmaceuticals Inc. (ACAD) Misled Shareholders Regarding the Viability of Pimavanserin for Dementia-Related Psychosis      

In April 2016, the 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.

On March 8, 2021, 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.”  On this news, Acadia’s stock price fell $20.76 per share or over 45%, to close at $25.092 per share on March 9, 2021.  Then, on April 5, 2021, Acadia issued a press release announcing it had received a Complete Response Letter from the FDA indicating that the pimavanserin sNDA could not be approved in its current form.  Specifically, the FDA Division of Psychiatry “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 over 17% to close at $21.18 per share on April 5, 2021.

Acadia Pharmaceuticals Inc. (ACAD) Shareholders Have Options

  • If you would like more information about your rights and potential remedies please send us a message. 

  • Please Note: Neither the submission to nor the receipt of information by Robbins LLP or one of its attorneys through this website constitutes an agreement by our firm to represent the individual and does not create an attorney-client relationship. Please do not send confidential or sensitive information through this website. This information should be communicated through a direct contact with an individual at the firm.

How can we help you?

CONTACT US TODAY | 1 800 350 6003 or [email protected]

Tell us your concerns