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Acadia's Nuplazid Hits A Review Roadblock, But Not A CRL (For Now)

 
• By Jessica Merrill

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.

Wooden roadblock in nature
The road to approval for a Nuplazid sNDA is uncertain • Source: Shutterstock

The outlook for the expansion of ACADIA Pharmaceuticals Inc.'s Nuplazid (pimavanserin) to treat hallucinations and delusions associated with dementia-related psychosis is uncertain after the company received an update from the US Food and Drug Administration. The company warned there could be a delay in approval of a supplemental new drug application (sNDA) for Nuplazid, but management did not have any details so the message was a confusing one for investors to absorb.

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