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Anavex (AVXL) Up 12% on Regulatory Update for Alzheimer's Drug
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Anavex Life Sciences (AVXL - Free Report) announced that it has initiated a regulatory submission of investigational oral blarcamesine (Anavex 2-73) for the treatment of Alzheimer’s Disease to the European Medicines Agency (EMA).
The marketing authorization application, subject to approval, will grant the company direct access to the European Union (EU) market for oral blarcamesine in the treatment of Alzheimer’s disease.
The company recently met with the EMA to discuss the debilitating pathology of Alzheimer’s disease as well as results obtained from its clinical program of blarcamesine in the same indication. The discussion included data obtained in the mid-late-stage ANAVEX 2-73-AD-004 study of blarcamesine in Alzheimer’s disease.
The stock of the company gained 11.6% on Monday, in response to the encouraging regulatory update. Year to date, shares of Anavex have lost 24.4% compared with the industry’s 23.1% decline.
Image Source: Zacks Investment Research
Anavex’s orally administered blarcamesine is an easier-to-use formulation than the currently available Alzheimer’s disease treatments. An oral treatment option for the same does not require complex logistics resources and added personnel for drug administration and monitoring for brain edema and brain bleeds.
Per AVXL, Alzheimer’s patients, taking the class of drugs called monoclonal antibodies, sometimes suffer from amyloid-related imaging abnormalities (ARIA). Notably, ARIA is a common side effect in this course of treatment and requires constant and repeated magnetic resonance imaging examination, which is challenging due to the scarcity of such equipment in certain regions of the EU. In addition, there are issues regarding affordability and inequalities in patient access within EU countries.
However, when Alzheimer’s patients were treated with blarcamesine in the phase IIb/III study, the candidate demonstrated a reduction of pathological aggregation of amyloid in early Alzheimer’s disease as well as a reduction of brain volume loss, a well-known marker of neurodegeneration. In the study, a statistically significant improvement in dementia symptoms was also observed upon treatment with blarcamesine.
Per the European Brain Council, there are approximately seven million people in Europe with Alzheimer’s disease, which is expected to double by 2030.
Anavex is also evaluating blarcamesine in several other central nervous system (CNS) indications. For instance, blarcamesine has successfully completed a phase IIa and phase IIb/III clinical study for Alzheimer's disease, phase II proof-of-concept study in Parkinson's disease dementia, and both phase II and phase III study in adult patients with Rett syndrome.
AVXL’s clinical-stage pipeline consists of another candidate, Anavex 3-71 (AF710B), which is currently in late-stage development to treat several CNS disorders, including Alzheimer’s disease.
In the past 30 days, the Zacks Consensus Estimate for Ligand’s 2023 earnings per share has remained constant at $5.10. During the same time frame, the estimate for Ligand’s 2024 earnings per share has remained constant at $4.59. Year to date, shares of LGND have lost 13%.
LGND’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 67.19%.
In the past 30 days, the Zacks Consensus Estimate for Acadia’s 2023 loss per share has narrowed from 37 cents to 34 cents. The estimate for Acadia’s 2024 earnings per share is pegged at 90 cents. Year to date, shares of ACAD have shot up 44%.
ACAD beat estimates in two of the trailing four quarters, missing the mark on the other two occasions, delivering an average earnings surprise of 20.69%.
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 declined 69.1%.
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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Anavex (AVXL) Up 12% on Regulatory Update for Alzheimer's Drug
Anavex Life Sciences (AVXL - Free Report) announced that it has initiated a regulatory submission of investigational oral blarcamesine (Anavex 2-73) for the treatment of Alzheimer’s Disease to the European Medicines Agency (EMA).
The marketing authorization application, subject to approval, will grant the company direct access to the European Union (EU) market for oral blarcamesine in the treatment of Alzheimer’s disease.
The company recently met with the EMA to discuss the debilitating pathology of Alzheimer’s disease as well as results obtained from its clinical program of blarcamesine in the same indication. The discussion included data obtained in the mid-late-stage ANAVEX 2-73-AD-004 study of blarcamesine in Alzheimer’s disease.
The stock of the company gained 11.6% on Monday, in response to the encouraging regulatory update. Year to date, shares of Anavex have lost 24.4% compared with the industry’s 23.1% decline.
Image Source: Zacks Investment Research
Anavex’s orally administered blarcamesine is an easier-to-use formulation than the currently available Alzheimer’s disease treatments. An oral treatment option for the same does not require complex logistics resources and added personnel for drug administration and monitoring for brain edema and brain bleeds.
Per AVXL, Alzheimer’s patients, taking the class of drugs called monoclonal antibodies, sometimes suffer from amyloid-related imaging abnormalities (ARIA). Notably, ARIA is a common side effect in this course of treatment and requires constant and repeated magnetic resonance imaging examination, which is challenging due to the scarcity of such equipment in certain regions of the EU. In addition, there are issues regarding affordability and inequalities in patient access within EU countries.
However, when Alzheimer’s patients were treated with blarcamesine in the phase IIb/III study, the candidate demonstrated a reduction of pathological aggregation of amyloid in early Alzheimer’s disease as well as a reduction of brain volume loss, a well-known marker of neurodegeneration. In the study, a statistically significant improvement in dementia symptoms was also observed upon treatment with blarcamesine.
Per the European Brain Council, there are approximately seven million people in Europe with Alzheimer’s disease, which is expected to double by 2030.
Anavex is also evaluating blarcamesine in several other central nervous system (CNS) indications. For instance, blarcamesine has successfully completed a phase IIa and phase IIb/III clinical study for Alzheimer's disease, phase II proof-of-concept study in Parkinson's disease dementia, and both phase II and phase III study in adult patients with Rett syndrome.
AVXL’s clinical-stage pipeline consists of another candidate, Anavex 3-71 (AF710B), which is currently in late-stage development to treat several CNS disorders, including Alzheimer’s disease.
Anavex Life Sciences Corp. Price and Consensus
Anavex Life Sciences Corp. price-consensus-chart | Anavex Life Sciences Corp. Quote
Zacks Rank and Stocks to Consider
Anavex currently has a Zacks Rank #3 (Hold).
Some better-ranked stocks worth mentioning are Ligand Pharmaceuticals (LGND - Free Report) , Acadia Pharmaceuticals (ACAD - Free Report) and Agenus (AGEN - Free Report) . While LGND sports a Zacks Rank #1 (Strong Buy), ACAD and AGEN carry a Zacks Rank #2 (Buy) 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 Ligand’s 2023 earnings per share has remained constant at $5.10. During the same time frame, the estimate for Ligand’s 2024 earnings per share has remained constant at $4.59. Year to date, shares of LGND have lost 13%.
LGND’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 67.19%.
In the past 30 days, the Zacks Consensus Estimate for Acadia’s 2023 loss per share has narrowed from 37 cents to 34 cents. The estimate for Acadia’s 2024 earnings per share is pegged at 90 cents. Year to date, shares of ACAD have shot up 44%.
ACAD beat estimates in two of the trailing four quarters, missing the mark on the other two occasions, delivering an average earnings surprise of 20.69%.
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 declined 69.1%.
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%.