April 19, 2021 - An investor in shares of ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD) filed a lawsuit in the U.S. District Court for the Southern District of California over alleged violations of Federal Securities Laws by ACADIA Pharmaceuticals Inc. in connection with certain allegedly false and misleading statements made between June 15, 2020 and April 4, 2021.
San Diego, CA based ACADIA Pharmaceuticals Inc., a biopharmaceutical company, focuses on the development and commercialization of small molecule drugs that address unmet medical needs in central nervous system disorders.
On Jul. 20, 2020, ACADIA Pharmaceuticals Inc. announced the U.S. FDA accepted for filing the sNDA. ACADIA Pharmaceuticals Inc. also reassured investors “[t]he FDA has also informed the company that it has not identified any potential review issues at this point in their evaluation and at this time they are not planning to hold an Advisory Committee meeting.”
On March 8, 2021, ACADIA Pharmaceuticals Inc. announced that on Mar. 3, 2021 the FDA informed the company that during review of the sNDA the agency identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time.
On April 5, 2021, pre-market, ACADIA Pharmaceuticals Inc. announced 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."
Shares of ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD) declined from $52.12 per share on February 22, 2021, to as low as $20.12 per share on April 12, 2021.
According to the complaint the plaintiff alleges on behalf of purchasers of ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD) common shares between June 15, 2020 and April 4, 2021, that the defendants violated Federal Securities Laws. More specifically, the plaintiff claims that between June 15, 2020 and April 4, 2021, the Defendants made false and/or misleading statements and/or failed to disclose that the materials submitted in support of the pimavanserin sNDA contained statistical and design deficiencies, that accordingly, the pimavanserin sNDA lacked the evidentiary support that the Company had led investors to believe it possessed, that the FDA was unlikely to approve the pimavanserin sNDA in its present form, and that as a result, the Company's public statements were materially false and misleading at all relevant times.