Acadia (ACAD) to Begin Study on ACP-101 for Hyperphagia in PWS
Acadia Pharmaceuticals ACAD announced adding a new phase III development candidate, ACP-101, to its rare disease portfolio. The investigational, intranasal formulation of ACP-101 is set to be evaluated for the treatment of hyperphagia in Prader-Willi syndrome (PWS).
We would like to remind the investors that Acadia had previously acquired worldwide rights to develop and commercialize ACP-101 with the acquisition of Levo Therapeutics in June 2022.
Year to date, shares of Acadia have gained 57.2% against the industry’s 6.3% fall.
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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. There is currently no FDA-approved treatment for the hyperphagia associated with PWS, constituting a serious unmet medical need.
Prior to this acquisition, Levo had conducted a phase III study to evaluate two doses of ACP-101, 3.2 mg and 9.6 mg, versus placebo three times daily. The study comprised three equally distributed cohorts of patients who received either of the two doses of ACP-101 or placebo thrice daily.
Top-line results from the phase III study conducted by Levo showed that ACP-101 was safe and overall well-tolerated, demonstrating nominally statistically significant efficacy at the 3.2 mg dose.
Acadia reported recently meeting with the FDA, reaching alignment to further evaluate the 3.2 mg dose of ACP-101 in a pivotal phase III study. If the phase III study becomes successful, Acadia plans to submit a new drug application for the treatment of hyperphagia in PWS to the FDA.
ACADIA Pharmaceuticals Inc. Price and Consensus
ACADIA Pharmaceuticals Inc. price-consensus-chart | ACADIA Pharmaceuticals Inc. Quote
Zacks Rank and Stocks to Consider
Acadia currently has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Adaptimmune Therapeutics ADAP, Akero Therapeutics AKRO and ADMA Biologics, Inc. ADMA, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 90 days, the Zacks Consensus Estimate for Adaptimmune Therapeutics’ 2023 loss per share has remained stable at 46 cents. During the same period, the estimate for Adaptimmune Therapeutics’ 2024 loss per share has narrowed from 74 cents to 56 cents. Year to date, shares of ADAP have fallen by 30.9%.
ADAP beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 36.89%.
In the past 90 days, the Zacks Consensus Estimate for Akero Therapeutics’ 2023 loss per share has narrowed from $3.46 to $2.80. During the same period, the estimate for Akero Therapeutics’ 2024 loss per share has narrowed from $3.66 to $3.27. Year to date, shares of AKRO have gained by 3.8%.
AKRO beat estimates in three of the trailing four quarters, missing the mark on one occasion, delivering an average earnings surprise of 7.96%.
In the past 90 days, the Zacks Consensus Estimate for ADMA Biologics’ 2023 loss per share has narrowed from 19 cents to 9 cents. The consensus estimate for 2024 earnings is currently pegged at 7 cents per share. Year to date, shares of ADMA have gained by 3.1%.
ADMA beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 19.13%.
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