- The FDA has issued a Complete Response Letter (CRL) to Acadia Pharmaceuticals Inc (NASDAQ:ACAD) regarding its supplemental marketing application for pimavanserin in hallucinations and delusions associated with Alzheimer’s disease psychosis (ADP).
- The CRL recommended that Acadia conduct an additional trial in ADP.
- The advisory committee voted 9-3 that Acadia’s pimavanserin doesn’t appear effective in treating ADP patients.
- While the FDA stated that Study 019 demonstrated a statistically significant treatment effect on its primary endpoint, they concluded that there are limitations in the interpretability of the 019 results.
- Also Read: Analysts Try To See Beyond Acadia’s Alzheimer’s Disease Psychosis.
- The FDA also stated that the positive treatment effect of pimavanserin on dementia-related psychosis in Study 045 (HARMONY) appeared to be driven by positive results in the Parkinson’s disease dementia (PDD) subgroup.
- The agency stated that PDD is subsumed within the currently approved Nuplazid Parkinson’s disease psychosis (PDP) indication. Up to 50% of PDP patients have dementia.
- Nuplazid was approved in the U.S. in 2016 and is the first and only treatment for hallucinations and delusions associated with PDP.
- Price Action: ACAD shares are down 3.01% at $15.15 during the premarket session on the last check Friday.
Bitcoin Drops Below $27,000; Pepe, Optimism Among Top Losers
Bitcoin (CRYPTO: BTC) moved lower, with the cryptocurrency prices falling below the key $27,000 level on Friday.
Ethereum (CRYPTO: ETH) also edged lower, but remained above the key $1,800 mark this morning.
