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FDA Confirms Positive Safety Profile of Acadia's Nuplazid

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FDA Confirms Positive Safety Profile of Acadia's Nuplazid

Acadia's shares soar more than 20% as the FDA issues a statement reaffirming the positive benefit-risk profile of Nuplazid for patients with Parkinson's disease psychosis.

Shares of ACADIA Pharmaceuticals Inc. ACAD soared 26.6% after the FDAissued a clear statement reaffirming the positive benefit-risk profile of Nuplazid (pimavanserin) for patients with Parkinson’s disease psychosis. However, shares of the company have decreased 36.5% year to date compared with the industry’s decline of 3.5%.

Nuplazid was approved by the FDA in April 2016 for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis, (PDP). It is the only drug approved in the United States for this indication. The approval was supported by a phase III study that demonstrated clinically robust and highly statistically significant efficacy, combined with other supportive studies.

There were reports of deaths and serious adverse events (SAEs) with the use of Nuplazid. However, based on post-marketing reports, the FDA concluded that it did not identify any new or unexpected safety findings with Nuplazid, or findings that are inconsistent with the established safety profile currently described in the drug label.

The agency stated that the drug’s benefits outweigh its risks for patients with hallucinations and delusions of Parkinson’s disease psychosis. The FDA said that Nuplazid and other antipsychotics already have warnings on their boxes, indicating a higher risk of death in elderly patients with the use of such drugs.

According to the agency, individuals with Parkinson's disease psychosis are more at risk of death due to their age, disease and other medical conditions. The FDA further added that patients taking Nuplazid for Parkinson’s disease psychosis should continue to use it as prescribed by their health care provider.

The FDA, however, reminded the health care providers to be aware of the risks described in the prescribing information. 

Sales of Nuplazid increased 87% in the second quarter.

ACADIA Pharmaceuticals Inc. Price

ACADIA Pharmaceuticals Inc. Price | ACADIA Pharmaceuticals Inc. Quote

Zacks Rank & Stocks to Consider

Acadia is a Zacks Rank #4 (Sell) stock.

Some better-ranked stocks in the biotech sector are Gilead Sciences Inc. GILD, Regeneron Pharmaceuticals Inc. REGN and Ligand Pharmaceuticals Inc. LGND. All of them carry a Zacks Rank #1 (Strong Buy).You can see the complete list of today’s Zacks #1 Rank stocks here.

Gilead’s earnings per share estimates have increased from $6.15 to $6.58 for 2018 and from $6.33 to $6.48 for 2019 over the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 6.43%. The stock has rallied 4.5% so far this year.

Regeneron’s earnings per share estimates have increased from $20.20 to $20.38 for 2018 and from $21.65 to $21.74 for 2019 over the past 30 days. The company delivered a positive earnings surprise in all of the trailing four quarters with an average beat of 8.18%. The stock has rallied 3.0% so far this year.

Ligand’s earnings per share estimates have moved up from $5.64 to $6.33 for 2018 and from $5.59 to $5.74 for 2019 in the last 30 days. The company delivered a positive earnings surprise in all of the trailing four quarters with an average beat of 59.54%. Share price of the company has increased 88.3% year to date.

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