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ACADIA Phase II Alzheimer's Drug Hits Primary Endpoint
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ACADIA Pharmaceuticals Inc. (ACAD - Free Report) announced that a phase II exploratory study (-019 Study) evaluating pimavanserin for the treatment of Alzheimer’s disease psychosis (AD Psychosis) met the primary endpoint.
Following the news, ACADIA shares rose more than 12%. In fact , the biotech company’s share price has gained 6.9% in the past one month, compared with the 4.2% fall witnessed by the Zacks classified Medical-Biomedical and Genetics industry.
Note that pimavanserin is approved for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis under the trade name Nuplazid, which was launched in May 2016.
Interestingly, the FDA has not approved any drug to treat AD Psychosis to date.
The double-blind, placebo-controlled exploratory phase II study randomized 181 patients on a one-to-one basis to receive either 34 mg of pimavanserin or placebo once daily. In the study, pimavanserin met the primary endpoint by leading to significant reduction in psychosis, one of the debilitating symptoms of Alzheimer’s disease, compared with placebo.
Psychosis was measured by the Neuropsychiatric Inventory-Nursing Home (NPI-NH) Psychosis score at week 6 of dosing (p=0.0451). The data revealed that pimavanserin led to a 3.76 point improvement in psychosis at week 6 compared to a 1.93 point improvement for placebo.
The secondary endpoint was the mean change in NPI-NH Psychosis score at week 12. While pimavanserin maintained the improvement in psychosis observed at week 6, it failed to demonstrate a statistically significant improvement over placebo.
Nevertheless, pimavanserin was generally well tolerated in the study and its safety profile was consistent with the previous studies.
ACADIA plans to present data from this study at a future medical conference.
Zacks Rank & Key Picks
ACADIA currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector include Cambrex Corporation , Heska Corporation and Anika Therapeutics Inc (ANIK - Free Report) . While Cambrex and Heska sport a Zacks Rank #1 (Strong Buy), Anika carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Heska’s earnings estimates improved 19.5% for 2016 and 10.9% for 2017 in the last 60 days. The company posted a positive earnings surprise in each of the four trailing quarters, with an average beat of 301.64%. Its share price has increased 85.5% year to date.
Cambrex’s earnings estimates increased 3.7% for 2016 and 4.9% for 2017 in the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters, with an average beat of 19.78%. Its share price is up 14.9% year to date.
Anika Therapeutics’ earnings estimates for 2016 and 2017 were up a respective 9.2% and 3.4% respectively in the last 60 days. The company has recorded a positive earnings surprise in each of the last four quarters, the average being 33.14%. Its share price is up 28.1% year to date.
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ACADIA Phase II Alzheimer's Drug Hits Primary Endpoint
ACADIA Pharmaceuticals Inc. (ACAD - Free Report) announced that a phase II exploratory study (-019 Study) evaluating pimavanserin for the treatment of Alzheimer’s disease psychosis (AD Psychosis) met the primary endpoint.
Following the news, ACADIA shares rose more than 12%. In fact , the biotech company’s share price has gained 6.9% in the past one month, compared with the 4.2% fall witnessed by the Zacks classified Medical-Biomedical and Genetics industry.
Note that pimavanserin is approved for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis under the trade name Nuplazid, which was launched in May 2016.
Interestingly, the FDA has not approved any drug to treat AD Psychosis to date.
The double-blind, placebo-controlled exploratory phase II study randomized 181 patients on a one-to-one basis to receive either 34 mg of pimavanserin or placebo once daily. In the study, pimavanserin met the primary endpoint by leading to significant reduction in psychosis, one of the debilitating symptoms of Alzheimer’s disease, compared with placebo.
Psychosis was measured by the Neuropsychiatric Inventory-Nursing Home (NPI-NH) Psychosis score at week 6 of dosing (p=0.0451). The data revealed that pimavanserin led to a 3.76 point improvement in psychosis at week 6 compared to a 1.93 point improvement for placebo.
The secondary endpoint was the mean change in NPI-NH Psychosis score at week 12. While pimavanserin maintained the improvement in psychosis observed at week 6, it failed to demonstrate a statistically significant improvement over placebo.
Nevertheless, pimavanserin was generally well tolerated in the study and its safety profile was consistent with the previous studies.
ACADIA plans to present data from this study at a future medical conference.
Zacks Rank & Key Picks
ACADIA currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector include Cambrex Corporation , Heska Corporation and Anika Therapeutics Inc (ANIK - Free Report) . While Cambrex and Heska sport a Zacks Rank #1 (Strong Buy), Anika carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Heska’s earnings estimates improved 19.5% for 2016 and 10.9% for 2017 in the last 60 days. The company posted a positive earnings surprise in each of the four trailing quarters, with an average beat of 301.64%. Its share price has increased 85.5% year to date.
Cambrex’s earnings estimates increased 3.7% for 2016 and 4.9% for 2017 in the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters, with an average beat of 19.78%. Its share price is up 14.9% year to date.
Anika Therapeutics’ earnings estimates for 2016 and 2017 were up a respective 9.2% and 3.4% respectively in the last 60 days. The company has recorded a positive earnings surprise in each of the last four quarters, the average being 33.14%. Its share price is up 28.1% year to date.
ACADIA PHARMA Price
ACADIA PHARMA Price | ACADIA PHARMA Quote
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In addition to the recommendations that are available to the public on our website, how would you like to follow all Zacks' private buys and sells in real time? Our experts cover all kinds of trades… from value to momentum . . . from stocks under $10 to ETF and option moves . . . from stocks that corporate insiders are buying up to companies that are about to report positive earnings surprises. You can even look inside exclusive portfolios that are normally closed to new investors. Starting today, for the next month, you can have unrestricted access. Click here for Zacks' private trades >>