- A panel of the FDA's outside experts voted 9-3 that Acadia Pharmaceuticals Inc's (NASDAQ: ACAD) pimavanserin doesn't appear to be effective at treating patients with Alzheimer's-related psychosis.
- The drug, Nuplazid, is already indicated for Parkinson's-related psychosis.
- Acadia tried and failed last year to get another FDA approval for Alzheimer's psychosis.
- Related: Acadia Stock Drops After FDA CRL For Pimavanserin Application In Hallucinations and Dementia-Related Psychosis.
- "We are disappointed with the outcome of today's vote. We will continue to work closely with the FDA as it completes its review of the totality of our efficacy and safety data to enable a full assessment of pimavanserin's benefit-risk in patients with ADP (NASDAQ:ADP)," said Steve Davis, CEO.
- Pimavanserin has slogged through a rough journey, with a late-stage fail in trials of patients with major depressive disorder in July 2020 and Phase 3 disappointment in schizophrenia patients in 2019.
- Analyst Reactions:
- HC Wainwright & Co maintains Acadia with a Buy and lowers the price target from $36 to $20.
- RBC Capital analyst keeps the rating unchanged at Outperform but lowers the price target from $32 to $26.
- Price Action: ACAD shares are down 31.42% at $13.38 during the premarket session on the last check Tuesday.
Read at Benzinga