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SAN FRANCISCO, April 5, 2021 /PRNewswire/ -- Hagens Berman invites Acadia Pharmaceuticals Inc. (NASDAQ: ACAD) investors with significant losses to submit your losses now. The firm is investigating possible securities law violations and certain investors may have valuable claims.
Acadia Pharmaceuticals Inc. (NASDAQ: ACAD) Investigation:
The investigation focuses on the accuracy of Acadia's disclosures concerning its supplemental new drug application ("sNDA") for NUPLAZID® (pimavanserin) for the treatment of hallucinations and delusions associated with dementia-related psychosis ("DRP").
On July 20, 2020, Acadia announced the U.S. FDA accepted for filing the sNDA. The company 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."
But on March 8, 2021, Acadia shocked its shareholders when it announced that on March 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.
Analysts were stunned by this news. RBC Capital Markets analyst Gregory Renza reportedly said that after receiving the notice on March 3rd and "a subsequent five days of ghosting," he now expects the FDA to issue a Complete Response Letter rejecting Acadia's application.
In response to these disclosures, Acadia's share price fell $20.76, or 45%, in a single trading day, on unusually heavy trading volume.
Most recently, on April 5, 2021, Acadia announced the FDA rejected the sNDA citing a lack of statistical significance regarding some of the subgroups of dementia and inadequate numbers of patients with some less common dementia subtypes. This news sent the price of Acadia shares crashing lower.
"We're focused on investors' losses and whether Acadia may have misled investors by concealing FDA-related review risks for the sNDA," said Reed Kathrein, the Hagens Berman partner leading the investigation.
If you are an Acadia investor and have significant losses, or have knowledge that may assist the firm's investigation, click here to discuss your legal rights with Hagens Berman.
Whistleblowers: Persons with non-public information regarding Acadia should consider their options to help in the investigation or take advantage of the SEC Whistleblower program. Under the new program, whistleblowers who provide original information may receive rewards totaling up to 30 percent of any successful recovery made by the SEC. For more information, call Reed Kathrein at 844-916-0895 or email ACAD@hbsslaw.com.
About Hagens Berman
Hagens Berman is a national law firm with nine offices in eight cities around the country and eighty attorneys. The firm represents investors, whistleblowers, workers and consumers in complex litigation. More about the firm and its successes is located at hbsslaw.com. For the latest news visit our newsroom or follow us on Twitter at @classactionlaw.
Reed Kathrein, 844-916-0895
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SOURCE Hagens Berman Sobol Shapiro LLP