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The Law Offices of Frank R. Cruz announces an investigation of Acadia Pharmaceuticals Inc. ("Acadia" or the "Company") (NASDAQ: ACAD) on behalf of investors concerning the Company’s possible violations of federal securities laws.
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Acadia is a biopharmaceutical company that develops a drug called pimavanserin as a treatment for dementia-related psychosis and as an adjunctive treatment for schizophrenia, as well as an adjunctive treatment for major depressive disorder. In June 2020, Acadia submitted a supplemental New Drug Application ("sNDA") with the U.S. Food and Drug Administration ("FDA") to expand pimavanserin’s label to include treatment for dementia-related psychosis.
On March 8, 2021, the Company revealed that, as part of its ongoing review of the 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 45.35%, to close at $25.02 per share on March 9, 2021, thereby injuring investors.
On April 5, 2021, pre-market, the Company disclosed receipt of 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 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."
On 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, thereby injuring investors further.
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If you purchased Acadia securities, have information or would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Frank R. Cruz, of The Law Offices of Frank R. Cruz, 1999 Avenue of the Stars, Suite 1100, Los Angeles, California 90067 at 310-914-5007, by email to firstname.lastname@example.org, or visit our website at www.frankcruzlaw.com. If you inquire by email please include your mailing address, telephone number, and number of shares purchased.
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