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.
