Acadia's Nuplazid Hits A Review Roadblock, But Not A CRL (For Now)
Deficiencies identified by the US FDA could delay the approval of pimavanserin for hallucinations associated with dementia-related psychosis, but Acadia did not have details for investors.
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Nuplazid Complete Response Letter For Dementia Psychosis Driven By Effectiveness Concerns In Subgroups
Acadia says the US FDA’s view has shifted from what was previously agreed upon for approval of an sNDA for pimavanserin in a broad dementia-related psychosis indication.
US FDA Throws Acadia A Curveball On Nuplazid For Dementia Psychosis
Acadia strikes out on potential near-term sNDA approval in a broad dementia-related psychosis indication. The firm said the agency’s view has shifted from what was previously agreed upon.
April User Fee Goal Calendar: Forecast Uncertain For Atopic Dermatitis Candidates, Nuplazid; Eohilia Could Be First For Orphan Use
While some of the most prominent applications with user fee goal dates in April could be delayed, thanks to JAK inhibitor safety concerns and US FDA communications, the upcoming month should see more than 15 decisions on applications.