- HC Wainwright says FDA's briefing document on ACADIA Pharmaceuticals Inc's (NASDAQ:ACAD) pimavanserin was not unexpected.
- It reiterates the stock with a Buy rating and a price target of $36.00.
- Related: Why ACADIA Pharmaceuticals Shares Are Trading Higher Today?
- The analysts believe the below points are left open for discussion when the AdCom members meet tomorrow:
- The closeness between Parkinson's disease dementia (PDD) and Alzheimer's disease dementia (ADD) in terms of disease mechanism argues approval of pimavanserin in ADP.
- Acadia's hypothesis that the robust response observed in PDD was due to the concomitant use of dopaminergic drugs resulting in a rapid relapse in the subgroup and thus resulting in the differential treatment effect in PDD when compared to the other subgroups.
- Interaction of treatment by dementia subgroup.
- Additional analyses of the AD subgroup's primary and the exploratory efficacy endpoints.
- Simulation study to see the effect of final analysis after completely removing the PDD subgroup.
- The effect of higher exposure of pimavanserin on the efficacy and analysis of plasma drug concentration and the primary endpoint.
- HC Wainwrights concludes that the documents do not aggressively turn Acadia's rationale down, giving an opportunity to argue in favor of approval of pimavanserin in Alzheimer's disease psychosis (ADP).
- Price Action: ACAD shares are up 5.83% at $19.79 during the market session on the last check Thursday.
