Acadia Pharmaceuticals Inc. (NASDAQ: ACAD) Securities Fraud Action:
The complaint alleges that Defendants misrepresented facts concerning Acadia’s supplemental new drug application (“sNDA”) for NUPLAZID® (pimavanserin), which treats dementia-related psychosis (“DRP”).
Specifically, on July 20, 2020, Acadia announced the FDA accepted for filing the sNDA and stated that its pivotal study for the drug showed a meaningful reduction of psychosis symptoms and a nearly 3X reduction in the risk of relapse for patients continuing on pimavanserin vs. placebo. Thereafter, the company repeatedly stated the FDA had not identified any potential review issues and reiterated the drug’s efficacy.
But the truth began to emerge on Mar. 8, 2021, when Acadia announced that on Mar. 3, 2021 the FDA informed the company that it had identified deficiencies in the sNDA.
Then, on Apr. 5, 2021, Acadia announced the FDA had 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.
“We’re focused on investors’ losses and proving Acadia 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.
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Reed Kathrein, 844