Shares of San Diego-based Acadia Pharmaceuticals (ACAD) rose 20% in Wednesday trading, one day ahead of an important FDA panel review for Nuplazid (pimavanserin), the company’s experimental Parkinson’s disease medication. The spike underscores investor confidence despite a mixed-bag internal review of the medication released last week.
The company focuses on central nervous system (CNS) disorders and has a collaboration deal with Allergan (AGN) focused on potential pain meds. Nuplazid is being tested on a variety of CNS diseases in clinical trials, including for psychosis associated with Parkinson’s and Alzheimer’s.
Regulators at the FDA didn’t clearly telegraph which way they’re leaning on the drug candidate. But Tuesday’s advisory committee meeting, which will involve an independent panel which gives the FDA guidance, will almost certainly feature some tough questions regarding Nuplazid’s safety and efficacy profile.
The FDA isn’t bound to follow these panels’ recommendations, but usually does.
According to the agency’s review, serious adverse events occurred in more than twice as many patients taking a 34-mg dose of Nuplazid than in those in the clinical trial’s placebo group. That includes an appreciably higher death rate.
However, regulators couldn’t pinpoint a precise reason driving the safety disparity between the drug and placebo arms and noted that there was some evidence of a clinical benefit reducing Parkinson’s-related psychotic symptoms.
If Acadia does manage to nab an FDA approval for the drug, it could become a blockbuster treatment which surpasses $1 billion in sales by the end of the decade, according to some analysts.
