HENDERSONVILLE, TN / May 1, 2021/ The Law Offices of Timothy L. Miles, who has been leading the fight to protect shareholder rights for over 20 years, is investigating Acadia Pharmaceuticals Inc. (NASDAQ: ACAD) on behalf of shareholders to determine whether certain Acadia officers and directors violated the Securities Exchange Act of 1934 and breached their fiduciary duties to the Company. Acadia is developing pimavanserin as a treatment for dementia-related psychosis and as an adjunctive treatment for schizophrenia and major depressive disorder.
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Acadia Pharmaceuticals Inc. (ACAD) Misled Shareholders Regarding the Viability of Pimavanserin for Dementia-Related Psychosis
According to a class action complaint filed against Acadia, 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 Shareholders Urged to Contact the Firm
If you purchased Peloton securities, have information, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Timothy L. Miles, Esquire, at 615-587-7384, Toll-Free at 855-846-6529, or by email to firstname.lastname@example.org. If you inquire by email please include your mailing address, telephone number, and the number shares owned.
About Timothy L. Miles
Timothy L. Miles is a nationally recognized shareholder rights attorney raised in Nashville, Tennessee. Last year, Mr Miles was recognized as a 2020 Top Ranked Lawyer; 2020 Top Rated Litigator; and a 2020 Elite Lawyer of The South by Martindale-Hubbell® and ALM. Mr. Miles also maintains the AV Preeminent Rating by Martindale-Hubbell®, their highest rating for both legal ability and ethics. Mr. Miles is a member of the prestigious Top 100 Civil Plaintiff Trial Lawyers: The National Trial Lawyers Association, a superb rated attorney by Avvo, a recipient of the Lifetime Achievement Award by Premier Lawyers of America (2019) and recognized as a Distinguished Lawyer, Recognizing Excellence in Securities Law, by Lawyers of Distinction (2019). Awards: Top Rated Litigator by Martindale-Hubbell® and ALM (2019-2021); Top Rated Lawyer by Martindale-Hubbell® and ALM (2019-2021); Elite Lawyer of The South by Martindale-Hubbell® and ALM (2019-2020); Member of the Top 100 Civil Plaintiff Trial Lawyers: The National Trial Lawyers Association (2017-2019); AV® Preeminent™ Rating by Martindale-Hubble® (2014-2020); PRR AV Preeminent Rating on Lawyers.com (2018-2020); The Top-Rated Lawyer in Litigation™ for Ethical Standards and Legal Ability (Martindale-Hubble® 2015); Lifetime Achievement Award by Premier Lawyers of America (2019); Distinguished Lawyer, Recognizing Excellence in Securities Law, by Lawyers of Distinction (2019-2020); Superb Rated Attorney (Avvo); Avvo Top Rated Lawyer for (Avvo 2017-2020). Mr. Miles has authored numerous publications advocating for shareholdings including most recently: Free Portfolio Monitoring Services Offered by Plaintiff Securities Firms Provides Significant Benefits to Investors (Timothy L. Miles, Dec. 3, 2019).
Timothy L. Miles, Esq.
Law Offices of Timothy L. Miles
124 Shiloh Ridge
Hendersonville, TN 37075
Leading the Fight to Protect Shareholder Rights for Over 19 Years