Acadia Pharmaceuticals (NASDAQ:ACAD) is a biopharmaceutical company based in San Diego and focused on the development of therapeutics to treat central nervous system disorders. Its lead asset, Nuplazid (pimavanserin), has been approved for the treatment of Parkinson’s disease psychosis. Nuplazid is also in development for the treatment of dementia-related psychosis.
Yesterday, a CNN article on the FAERS database Nuplazid death count highlighted concerns from a non-profit medication-error watchdog organization (ISMP) that the data could represent a safety signal for the drug. As a reminder, the FDA has access to real-world adverse event data through FAERS and through quarterly PADER submissions from Acadia.
Needham analyst Alan Carr spoke with management to get a better sense of about the situation: “Mgmt indicated that at no point since approval of the drug in 2016 has the FDA raised the topic of an elevated mortality risk w/ Nuplazid, despite opportunities to do so during End of Phase 2 Dementia Psychosis mtgs and during the currently ongoing 34mg tablet NDA review. (Rather, we note the FDA did grant another Breakthrough designation for the drug in Oct 2017.)”
“Nevertheless, given the attention brought to the drug by the CNN article, it seems probable the FDA may request additional data from Acadia and conduct a thorough review. Outcome of such a review is uncertain, but based on the publicly available safety/ efficacy data and apparent favorable FDA disposition towards the drug so far, we are inclined to believe Nuplazid is likely to remain available to patients. No other drugs are approved for Parkinsons Disease Psychosis (PDP),” Carr added.
As such, Carr reiterates a Buy rating on ACAD stock, with a $49.00 price target, which implies a 176% upside from today’s closing price. (To watch Carr’s track record, click here)
Wall Street is predominantly showcasing positive sentiment on the drug maker, with TipRanks analytics demonstrating ACAD as a Buy. Based on 7 analysts polled in the last 12 months, six are bullish on Acadia stock while only one remains sidelined. The 12-month average price target stands at $52.83, marking a nearly 200% upside from where the stock is currently trading.