After suffering rejection from the FDA in April, Acadia Pharmaceuticals Inc (NASDAQ:ACAD) is making another bid to expand the scope of its Parkinson's disease med Nuplazid.
- Acadia plans to resubmit its application for Nuplazid (pimavanserin) to treat hallucinations and delusions associated with dementia, homing specifically on patients with Alzheimer's disease psychosis (ADP).
- The Company is targeting Q1 of 2022 for its resubmission.
- "Following our recent meetings with the FDA, we plan to resubmit our sNDA for pimavanserin, narrowing the proposed indication from dementia-related psychosis to Alzheimer's disease psychosis," Steve Davis, Acadia's CEO, said in a statement.
- Related: Acadia Pharma Jumps After Rett Syndrome Candidate Aces Phase 3 Study
- The resubmission should demonstrate Nuplazid's benefit in ADP patients, without worsening cognition or motor function, Acadia predicts.
- The Company will also supply the regulator with additional analyses of the studies "that validate the primary conclusions from each study and address the concerns raised in the FDA's complete response letter."
- Price Action: ACAD shares are down 20.50% at $21.52 during the market session on the last check Tuesday.
