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- The FDA has issued a Complete Response Letter (CRL) to Acadia Pharmaceuticals Inc ACAD regarding its supplemental marketing application (for Nuplazid (pimavanserin) for the treatment of hallucinations and delusions associated with dementia-related psychosis (DRP).
- In the CRL, Psychiatry's division cited a lack of statistical significance in some subgroups of dementia and insufficient numbers of patients with specific less common dementia subtypes.
- In 2019, the company presented topline data from the DRP HARMONY study.
- Pimavanserin met the study's primary endpoint and was stopped at the pre-planned interim analysis by significantly reducing the risk of relapse of psychosis by 2.8 fold compared to placebo.
- Additionally, pimavanserin met the key secondary endpoint by significantly reducing the risk of discontinuation for any reason by 2.2 fold.
- Statistical separation by dementia subgroups and certain minimum numbers of patients with specific subtypes were not among the prespecified requirements.
- The division also stated in the CRL that it considers the Phase 2 Alzheimer's disease psychosis study -019, a supportive study for filing, not to be adequate and well-controlled.
- It stated that the study was a single-center study with no type I error control of secondary endpoints in which certain protocol deviations occurred.
- There were no safety issues or concerns raised in the CRL.
- "We will immediately request a Type A meeting to work with the FDA to address the CRL," said Steve Davis, CEO of Acadia.
- Price Action: ACAD shares dropped 15.2% at $21.87 in the premarket session on the last check Monday.
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ACADACADIA Pharmaceuticals Inc
$22.51-0.18%
Edge Rankings
Momentum
83.21
Growth
N/A
Quality
N/A
Value
52.46
Price Trend
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Medium
Long
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