Acadia Pharmaceuticals Inc. ACAD announced that it has initiated a mid-phase 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 new mechanism of action, working mainly as an inverse agonist at 5-HT.2A receiver Currently, there are no FDA-approved treatments for ADP. With ACP-204, Acadia seeks 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-phase program consists of a single phase II study and two phase III studies that have an almost identical design.
Year to date, shares of Acadia are up 39% versus the industry’s 23.8% decline.
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The ongoing 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 to placebo. The primary endpoint of the phase II study is the change from baseline in the Scale for the Rating 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.
According to 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 patients with Alzheimer’s disease experience psychosis, often consisting of hallucinations and delusions.
These symptoms of ADP are often frequent and severe in nature and may recur over time. This affects the quality of life of patients living with ADP. In rare severe cases, psychosis in patients with dementia has also resulted in death.
Currently, Acadia markets the first and 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 US market.
ACAD is also simultaneously evaluating Nuplazid in schizophrenia-negative symptoms.
ACADIA Pharmaceuticals Inc. Price and Agreement
ACADIA Pharmaceuticals Inc. price consensus chart | Quote from ACADIA Pharmaceuticals Inc
Zacks Rank and Other Stocks to Consider
Acadia currently carries a Zacks Rank #2 (Buy).
Some other top rated stocks worth mentioning are Puma Biotechnology, Inc. bye ADMA Biologics ADMA and Agenus AGEN. While PBYI has a Zacks Rank #1 (Strong Buy), ADMA and AGEN carry a Zacks Rank #2 each currently.
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 earnings per share in 2024 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 in the remaining occasion, delivering a four-quarter average surprise of 76.55%.
In the past 30 days, ADMA Biologics’ 2023 loss per share narrowed from 6 cents to 3 cents. The estimate for ADMA Biologics’ earnings per share in 2024 is set at 16 cents. Year to date, shares of ADMA have lost 3.9%.
ADMA beat estimates in three of the back four quarters and matched in one, delivering an average surprise of 63.57%.
In the past 30 days, the Zacks Consensus Estimate for Agenus’ 2023 earnings per share narrowed from 77 cents to 63 cents. During the same time frame, the estimate for the loss per share of Agenus in 2024 narrowed from 70 cents to 45 cents. Year to date, AGEN shares have plunged 70.8%.
AGEN beat estimates in one of the back four quarters, matching in one and missing the mark on the other two occasions, delivering an average earnings surprise of 0.49%.
(We are republishing this article to correct an error. The original article, published on November 28, 2023, should no longer be trusted.)
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