NEW YORK, May 20, 2021 (GLOBE NEWSWIRE) – Pomerantz LLP announces that a class action lawsuit has been filed against Acadia Pharmaceuticals Inc. (âAcadiaâ or the âCompanyâ) (NASDAQ: ACAD) and certain of its officers. The class action suit, filed in the United States District Court for the Southern District of California, and registered as 21-cv-00762, is in the name of a group consisting of all persons and entities other than the defendants who purchased or otherwise acquired Acadia securities between June 15, 2020 and April 4, 2021, both dates inclusive (the âClass Action Periodâ), seeking to recover damages caused by defendants’ violations of federal securities laws and to bring remedies under sections 10 (b) and 20 (a) of the Securities Exchange Act of 1934 (the âExchange Actâ) and rule 10b-5 promulgated thereunder, against the Company and some of its senior officials.
If you are a shareholder who purchased Acadia securities during the Class Period, you have until June 18, 2021 to ask the court to appoint you as the class lead plaintiff. A copy of the complaint can be obtained at www.pomerantzlaw.com. To discuss this action, contact Robert S. Willoughby at [email protected] or 888.476.6529 (or 888.4-POMLAW), toll free, Ext. 7980. Those inquiring by e-mail are encouraged to provide their mailing address, telephone number and the number of shares purchased.
Acadia is a biopharmaceutical company focused 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 adjunct to schizophrenia, as well as an adjunct to major depressive disorder.
In April 2016, the United States Food and Drug Administration (âFDAâ) 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 (âsNDAâ) to the FDA to expand the label of pimavanserin to include the treatment of dementia-related psychosis (âpimavanserin sNDAâ).
The complaint alleges that throughout the period of the action, the defendants made materially false and misleading statements regarding the activities of the company. Specifically, the defendants made false and / or misleading statements and / or failed to disclose that: (i) the documents submitted in support of pimavanserin sNDA contained statistical and design flaws; (ii) therefore, pimavanserin sNDA did not have the evidence that the Company had led investors to believe that it possessed; (iii) it was unlikely that the FDA would approve pimavanserin sNDA in its current form; and (iv) therefore, the Company’s public statements were materially false and misleading at all material times.
On March 8, 2021, post-marketing, Acadia issued a press release providing a regulatory update on pimavanserin sNDA, revealing âthat the company has received notification from [FDA] on March 3, 2021, stating that, as part of its ongoing review of [sNDA], the FDA has identified gaps that prevent discussion of labeling and post-market requirements / commitments at this time. “Acadia has indicated that”[t]The notification does not specify the shortcomings identified by the FDA and no clarification has been provided by the FDA at this time. “
At 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, prior to market launch, Acadia issued a press release announcing that the company had received a Full Response Letter (âCRLâ) from the FDA stating that pimavanserin sNDA could not be approved in its current form. Specifically, the press release stated that “the [FDA Division of Psychiatry], in CSF, cited a lack of statistical significance in some of the dementia subgroups and an insufficient number of patients with certain less common dementia subtypes due to the lack of substantial evidence of efficacy to support the approval. “
At 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.
Pomerantz, with offices in New York, Chicago, Los Angeles and Paris, is recognized as one of the leading firms in the areas of corporate, securities and antitrust litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz was a pioneer in the field of class actions in securities. Today, more than 80 years later, Pomerantz continues the tradition it established, fighting for the rights of victims of securities fraud, breach of fiduciary duty and professional misconduct. The firm has recovered numerous indemnities of several million dollars on behalf of the members of the group. See www.pomerantzlaw.com
Robert S. Willoughby
888-476-6529 ext. 7980