Leerink Affirms ACADIA Pharma (ACAD) at 'Outperform'; Pimavanserin Briefing Docs More Crticial than Expected
Leerink affirms ACADIA Pharma (Nasdaq: ACAD) with an Outperform rating and $40 price target after the FDA Psychopharmacologic Drugs Advisory Committee released the pimavanserin briefing documents last Friday.
Analyst Paul Matteis commented, On balance, the documents are more critical than we expected, though FDA's three voting questions appear to set a favorable framework for discussion of risk/benefit. The questions the panel will be exploring are: (1) is there substantial evidence of pimavanserin efficacy, (2) whether ACAD has fully characterized the safety profile of pimavanserin and (3) do the benefits of the drug outweigh its risks. Surprisingly, QTc prolongation, although mentioned, was not characterized as a meaningful safety issue.
The documents instead focus on the clinically meaningfulness of a -23.1% improvement in SAPS-PD (Scale for Assessment of Positive Symptoms - Parkinson's Disease) score and how this should be viewed in the context of higher rates of serious adverse events (SAEs) and deaths (3 to 1) observed on pimavanserin relative to placebo. In sum, given the (1) lack of approved agents for Parkinson's disease psychosis [PDP], (2) the widespread off-label use of antipsychotics, which have safety risks, and (3) the generally positive voting history of the psychopharm committee, we continue to believe pimavanserin approval (with a black box warning, if this comes up) will be the most likely recommendation of the panel,
Matteis noted.
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