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

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.

After markets closed on 8 March, Acadia provided an update on the status of the review, stating that the FDA told the company on 3 March that it had identified deficiencies that would prevent the agency from moving forward with labeling and post-marketing commitment discussions