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Acadia (ACAD) Begins Alzheimer's Disease Psychosis Study (Revised)
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Acadia Pharmaceuticals Inc. (ACAD - Free Report) announced that it has initiated a mid-stage study to evaluate the safety and efficacy of its investigational candidate, ACP-204, in the treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis (ADP).
ACP-204 has a novel mechanism of action, working primarily as an inverse agonist at the 5-HT2A receptor. Currently, there are no FDA-approved treatments for ADP. With ACP-204, Acadia is looking to address the large unmet medical need in this indication.
The phase II study initiated by the company is the first part of the planned phase II/III clinical program for ACP-204 in the treatment of ADP. The mid-late-stage program comprise a single phase II study and two phase III studies which have almost identical design.
Year to date, shares of Acadia have shot up 39% against the industry’s 23.8% decline.
Image Source: Zacks Investment Research
The initiated mid-stage study is set to enroll approximately 318 ADP patients and will evaluate treatment with two doses of ACP-204 (30 mg and 60 mg) compared with placebo. The primary endpoint of the phase II study is the change from baseline in the Scale for the Assessment of Positive Symptoms–Hallucinations and Delusions subscales total score in the sixth week.
After completing the phase II portion of the mid-late-stage clinical program for ACP-204, eligible patients will then progress into phase III. Acadia expects to enroll approximately 378 ADP patients in each of the planned phase III studies.
ACAD also reported that patients who complete the phase III studies will have the option to participate in a long-term open-label extension study.
Per the Alzheimer’s Association, more than 6.5 million people in the United States are living with Alzheimer’s disease. Of these 6.5 million people, about 30% of Alzheimer’s disease patients experience psychosis, commonly consisting of hallucinations and delusions.
These symptoms of ADP are often frequent and severe in nature and may recur over time. This takes a serious toll on the quality of life of patients living with ADP. In rare severe cases, psychosis in patients with dementia has also resulted in death.
At present, Acadia markets the first and the only FDA-approved treatment for hallucinations and delusions associated with Parkinson’s disease psychosis, Nuplazid (pimavanserin). The drug was launched in May 2016 in the U.S. market.
ACAD is also simultaneously evaluating Nuplazid in schizophrenia-negative symptoms.
Some other top-ranked stocks worth mentioning are Puma Biotechnology, Inc. (PBYI - Free Report) , ADMA Biologics (ADMA - Free Report) and Agenus (AGEN - Free Report) . While PBYI sports a Zacks Rank #1 (Strong Buy), ADMA and AGEN carry a Zacks Rank #2 each at present.
In the past 30 days, the Zacks Consensus Estimate for Puma Biotech’s 2023 earnings per share has increased from 67 cents to 73 cents. During the same time frame, the estimate for Puma Biotech’s 2024 earnings per share has increased from 56 cents to 62 cents. Year to date, shares of PBYI have lost 8.3%.
PBYI’s earnings beat estimates in three of the last four quarters while missing the same on the remaining occasion, delivering a four-quarter average earnings surprise of 76.55%.
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2023 loss per share has narrowed from 6 cents to 3 cents. The estimate for ADMA Biologics’ 2024 earnings per share is pegged at 16 cents. Year to date, shares of ADMA have lost 3.9%.
ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 63.57%.
In the past 30 days, the Zacks Consensus Estimate for Agenus’ 2023 loss per share has narrowed from 77 cents to 63 cents. During the same time frame, the estimate for Agenus’ 2024 loss per share has narrowed from 70 cents to 45 cents. Year to date, shares of AGEN have plunged 70.8%.
AGEN beat estimates in one of the trailing four quarters, matching in one and missing the mark on the other two occasions, delivering an average earnings surprise of 0.49%.
(We are reissuing this article to correct a mistake. The original article, issued on November 28, 2023, should no longer be relied upon.)
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Acadia (ACAD) Begins Alzheimer's Disease Psychosis Study (Revised)
Acadia Pharmaceuticals Inc. (ACAD - Free Report) announced that it has initiated a mid-stage study to evaluate the safety and efficacy of its investigational candidate, ACP-204, in the treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis (ADP).
ACP-204 has a novel mechanism of action, working primarily as an inverse agonist at the 5-HT2A receptor. Currently, there are no FDA-approved treatments for ADP. With ACP-204, Acadia is looking to address the large unmet medical need in this indication.
The phase II study initiated by the company is the first part of the planned phase II/III clinical program for ACP-204 in the treatment of ADP. The mid-late-stage program comprise a single phase II study and two phase III studies which have almost identical design.
Year to date, shares of Acadia have shot up 39% against the industry’s 23.8% decline.
Image Source: Zacks Investment Research
The initiated mid-stage study is set to enroll approximately 318 ADP patients and will evaluate treatment with two doses of ACP-204 (30 mg and 60 mg) compared with placebo. The primary endpoint of the phase II study is the change from baseline in the Scale for the Assessment of Positive Symptoms–Hallucinations and Delusions subscales total score in the sixth week.
After completing the phase II portion of the mid-late-stage clinical program for ACP-204, eligible patients will then progress into phase III. Acadia expects to enroll approximately 378 ADP patients in each of the planned phase III studies.
ACAD also reported that patients who complete the phase III studies will have the option to participate in a long-term open-label extension study.
Per the Alzheimer’s Association, more than 6.5 million people in the United States are living with Alzheimer’s disease. Of these 6.5 million people, about 30% of Alzheimer’s disease patients experience psychosis, commonly consisting of hallucinations and delusions.
These symptoms of ADP are often frequent and severe in nature and may recur over time. This takes a serious toll on the quality of life of patients living with ADP. In rare severe cases, psychosis in patients with dementia has also resulted in death.
At present, Acadia markets the first and the only FDA-approved treatment for hallucinations and delusions associated with Parkinson’s disease psychosis, Nuplazid (pimavanserin). The drug was launched in May 2016 in the U.S. market.
ACAD is also simultaneously evaluating Nuplazid in schizophrenia-negative symptoms.
ACADIA Pharmaceuticals Inc. Price and Consensus
ACADIA Pharmaceuticals Inc. price-consensus-chart | ACADIA Pharmaceuticals Inc. Quote
Zacks Rank and Other Stocks to Consider
Acadia currently carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks worth mentioning are Puma Biotechnology, Inc. (PBYI - Free Report) , ADMA Biologics (ADMA - Free Report) and Agenus (AGEN - Free Report) . While PBYI sports a Zacks Rank #1 (Strong Buy), ADMA and AGEN carry a Zacks Rank #2 each at present.
You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, the Zacks Consensus Estimate for Puma Biotech’s 2023 earnings per share has increased from 67 cents to 73 cents. During the same time frame, the estimate for Puma Biotech’s 2024 earnings per share has increased from 56 cents to 62 cents. Year to date, shares of PBYI have lost 8.3%.
PBYI’s earnings beat estimates in three of the last four quarters while missing the same on the remaining occasion, delivering a four-quarter average earnings surprise of 76.55%.
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2023 loss per share has narrowed from 6 cents to 3 cents. The estimate for ADMA Biologics’ 2024 earnings per share is pegged at 16 cents. Year to date, shares of ADMA have lost 3.9%.
ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 63.57%.
In the past 30 days, the Zacks Consensus Estimate for Agenus’ 2023 loss per share has narrowed from 77 cents to 63 cents. During the same time frame, the estimate for Agenus’ 2024 loss per share has narrowed from 70 cents to 45 cents. Year to date, shares of AGEN have plunged 70.8%.
AGEN beat estimates in one of the trailing four quarters, matching in one and missing the mark on the other two occasions, delivering an average earnings surprise of 0.49%.
(We are reissuing this article to correct a mistake. The original article, issued on November 28, 2023, should no longer be relied upon.)