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Acadia (ACAD) Begins Study on ACP-101 for Hyperphagia in PWS
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Acadia Pharmaceuticals Inc. (ACAD - Free Report) announced that it has initiated a late-stage study evaluating the efficacy and safety of carbetocin nasal spray (ACP-101) for the treatment of hyperphagia in Prader-Willi syndrome (PWS).
Acadia had previously acquired worldwide rights to develop and commercialize ACP-101 with the acquisition of Levo Therapeutics in June 2022.
PWS is a rare neurobehavioral genetic disorder that affects approximately 8,000 to 10,000 patients in the United States. PWS affects the functioning of the hypothalamus and other aspects of the brain giving rise to a variety of behavioral problems among different individuals.
The most common symptom of PWS is hyperphagia. Notably, hyperphagia is described as a false and unrelenting state of starvation, which is a characteristic of PWS. The patients of PWS require constant supervision to prevent life-threatening risks, including gastric rupture, irregular swallowing and choking.
There is currently no FDA-approved treatment for the hyperphagia associated with PWS, constituting a serious unmet medical need.
Year to date, shares of Acadia have gained 39.9% against the industry’s 23.2% fall.
Image Source: Zacks Investment Research
The planned phase III COMPASS PWS study will be conducted over 12 weeks to evaluate the safety and efficacy of carbetocin nasal spray 3.2 mg, which will be administered thrice daily in 170 PWS patients. The intended patient population will comprise both pediatric and adult patients aged five to 30 years.
The primary efficacy endpoint of the COMPASS PWS study is the change from baseline to week 12 on the hyperphagia questionnaire for clinical trials (HQ-CT) score. The HQ-CT is a caregiver’s assessment for hyperphagia-related behaviors.
Enrolled patients who complete the late-stage study will be given the option to participate in a long-term extension study, which is designed to investigate the safety and tolerability of long-term treatment with ACP-101.
In a previously conducted phase III study by Levo (before getting acquired by Acadia), carbetocin nasal spray 3.2 mg was observed to reduce hyperphagia-related behaviors.
Subject to the success of the phase III COMPASS PWS study, Acadia plans to submit a new drug application for the treatment of hyperphagia in PWS to the FDA.
Currently, carbetocin nasal spray enjoys the FDA’s Orphan Drug, Fast Track and Rare Pediatric Disease designations in the United States.
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 7.8%.
PBYI’s earnings beat estimates in three of the last four quarters while missing on one occasion, delivering a four-quarter average earnings surprise of 76.55%.
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ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 63.57%.
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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%.
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Acadia (ACAD) Begins Study on ACP-101 for Hyperphagia in PWS
Acadia Pharmaceuticals Inc. (ACAD - Free Report) announced that it has initiated a late-stage study evaluating the efficacy and safety of carbetocin nasal spray (ACP-101) for the treatment of hyperphagia in Prader-Willi syndrome (PWS).
Acadia had previously acquired worldwide rights to develop and commercialize ACP-101 with the acquisition of Levo Therapeutics in June 2022.
PWS is a rare neurobehavioral genetic disorder that affects approximately 8,000 to 10,000 patients in the United States. PWS affects the functioning of the hypothalamus and other aspects of the brain giving rise to a variety of behavioral problems among different individuals.
The most common symptom of PWS is hyperphagia. Notably, hyperphagia is described as a false and unrelenting state of starvation, which is a characteristic of PWS. The patients of PWS require constant supervision to prevent life-threatening risks, including gastric rupture, irregular swallowing and choking.
There is currently no FDA-approved treatment for the hyperphagia associated with PWS, constituting a serious unmet medical need.
Year to date, shares of Acadia have gained 39.9% against the industry’s 23.2% fall.
Image Source: Zacks Investment Research
The planned phase III COMPASS PWS study will be conducted over 12 weeks to evaluate the safety and efficacy of carbetocin nasal spray 3.2 mg, which will be administered thrice daily in 170 PWS patients. The intended patient population will comprise both pediatric and adult patients aged five to 30 years.
The primary efficacy endpoint of the COMPASS PWS study is the change from baseline to week 12 on the hyperphagia questionnaire for clinical trials (HQ-CT) score. The HQ-CT is a caregiver’s assessment for hyperphagia-related behaviors.
Enrolled patients who complete the late-stage study will be given the option to participate in a long-term extension study, which is designed to investigate the safety and tolerability of long-term treatment with ACP-101.
In a previously conducted phase III study by Levo (before getting acquired by Acadia), carbetocin nasal spray 3.2 mg was observed to reduce hyperphagia-related behaviors.
Subject to the success of the phase III COMPASS PWS study, Acadia plans to submit a new drug application for the treatment of hyperphagia in PWS to the FDA.
Currently, carbetocin nasal spray enjoys the FDA’s Orphan Drug, Fast Track and Rare Pediatric Disease designations in the United States.
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 7.8%.
PBYI’s earnings beat estimates in three of the last four quarters while missing on one 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 4.6%.
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 67.6%.
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%.