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Alnylam (ALNY) Reports Positive Results From APOLLO-B Study
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Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) announced new positive results from an interim analysis of exploratory data from the open-label extension (“OLE”) period of the phase III APOLLO-B study of patisiran for the treatment of transthyretin-mediated (“ATTR”) amyloidosis with cardiomyopathy.
The results were presented at the Annual Congress of the Heart Failure Association of the European Society of Cardiology.
Patisiran is currently marketed as Onpattro in the United States and Europe for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. Onpattro is the first and only FDA-approved treatment for this indication.
Alnylam is planning to expand the label of Onpattro in ATTR amyloidosis patients with cardiomyopathy. In September 2022, Alnylam reported that the phase III APOLLO-B study, evaluating patisiran for the treatment of ATTR amyloidosis with cardiomyopathy, met its primary endpoint of change from baseline in the 6-Minute Walk Test versus placebo at 12 months. The study also met the first secondary endpoint of change from baseline in quality of life versus placebo.
In the past year, shares of Alnylam have shot up 48.6% against the industry’s 6.5% decline.
Image Source: Zacks Investment Research
The reported interim analysis was carried out on 18-month data of the APOLLO-B study. Results indicated that the previously achieved primary endpoint, health status and quality of life, observed at the end of 12 months of the same study, were sustained with continued treatment with patisiran during the OLE period (at the end of 18 months).
It was observed that the patients, who received patisiran for 18 months, experienced no cardiac stress and injury. Moreover, patients who were previously treated with placebo for 12 months, upon moving to the OLE period for treatment with patisiran, appeared to show slowing of disease progression or relative stabilization across these same endpoints at month 18.
Observations made in the interim analysis were not statistically significant. However, the results showed favorable evidence of benefits in cardiac outcomes between treatment with patisiran and placebo, although the APOLLO-B study was not designed to demonstrate the same.
The safety profile of the drug was encouraging, consistent with the underlying disease and the known safety profile of patisiran, with no new safety concerns identified. Adverse events observed were mostly mild or moderate in severity. The most common treatment-related adverse event was infusion-related reactions.
In December 2022, Alnylam filed a supplemental new drug application (sNDA) with the FDA, which has been accepted by the FDA for review. The application seeks approval to expand Onpattro’s label for treating cardiomyopathy of ATTR amyloidosis in adults. A decision is expected on Oct 8, 2023. The company further reported that the 18-month data, from the interim analysis of the OLE period, was submitted to the FDA as an amendment to the sNDA for patisiran for the treatment of the cardiomyopathy of ATTR amyloidosis.
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ALLO beat estimates in three of the trailing four quarters, missing the mark on one occasion, delivering an average earnings surprise of 5.08%.
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Alnylam (ALNY) Reports Positive Results From APOLLO-B Study
Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) announced new positive results from an interim analysis of exploratory data from the open-label extension (“OLE”) period of the phase III APOLLO-B study of patisiran for the treatment of transthyretin-mediated (“ATTR”) amyloidosis with cardiomyopathy.
The results were presented at the Annual Congress of the Heart Failure Association of the European Society of Cardiology.
Patisiran is currently marketed as Onpattro in the United States and Europe for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. Onpattro is the first and only FDA-approved treatment for this indication.
Alnylam is planning to expand the label of Onpattro in ATTR amyloidosis patients with cardiomyopathy. In September 2022, Alnylam reported that the phase III APOLLO-B study, evaluating patisiran for the treatment of ATTR amyloidosis with cardiomyopathy, met its primary endpoint of change from baseline in the 6-Minute Walk Test versus placebo at 12 months. The study also met the first secondary endpoint of change from baseline in quality of life versus placebo.
In the past year, shares of Alnylam have shot up 48.6% against the industry’s 6.5% decline.
Image Source: Zacks Investment Research
The reported interim analysis was carried out on 18-month data of the APOLLO-B study. Results indicated that the previously achieved primary endpoint, health status and quality of life, observed at the end of 12 months of the same study, were sustained with continued treatment with patisiran during the OLE period (at the end of 18 months).
It was observed that the patients, who received patisiran for 18 months, experienced no cardiac stress and injury. Moreover, patients who were previously treated with placebo for 12 months, upon moving to the OLE period for treatment with patisiran, appeared to show slowing of disease progression or relative stabilization across these same endpoints at month 18.
Observations made in the interim analysis were not statistically significant. However, the results showed favorable evidence of benefits in cardiac outcomes between treatment with patisiran and placebo, although the APOLLO-B study was not designed to demonstrate the same.
The safety profile of the drug was encouraging, consistent with the underlying disease and the known safety profile of patisiran, with no new safety concerns identified. Adverse events observed were mostly mild or moderate in severity. The most common treatment-related adverse event was infusion-related reactions.
In December 2022, Alnylam filed a supplemental new drug application (sNDA) with the FDA, which has been accepted by the FDA for review. The application seeks approval to expand Onpattro’s label for treating cardiomyopathy of ATTR amyloidosis in adults. A decision is expected on Oct 8, 2023. The company further reported that the 18-month data, from the interim analysis of the OLE period, was submitted to the FDA as an amendment to the sNDA for patisiran for the treatment of the cardiomyopathy of ATTR amyloidosis.
Alnylam Pharmaceuticals, Inc. Price and Consensus
Alnylam Pharmaceuticals, Inc. price-consensus-chart | Alnylam Pharmaceuticals, Inc. Quote
Zacks Rank and Stocks to Consider
Alnylam currently has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Allogene Therapeutics (ALLO - Free Report) , Anixa Biosciences (ANIX - Free Report) and ADMA Biologics, Inc. (ADMA - Free Report) , 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 Allogene Therapeutics’ 2023 loss per share has narrowed from $2.83 to $2.32. In the past year, shares of Allogene Therapeutics have fallen by 18.5%.
ALLO beat estimates in three of the trailing four quarters, missing the mark on one occasion, delivering an average earnings surprise of 5.08%.
In the past 90 days, the Zacks Consensus Estimate for Anixa Therapeutics’ 2023 loss per share has narrowed from 62 cents to 43 cents. In the past year, shares of Anixa Therapeutics have increased by 5.5%.
ANIX beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 24.04%.
In the past 90 days, the Zacks Consensus Estimate for ADMA Biologics’ 2023 loss per share has narrowed from 19 cents to 9 cents. In the past year, shares of ADMA Biologics have increased by 98.1%.
ADMA beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 19.13%.