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Alnylam (ALNY) Posts Positive Top-Line Data From Vutrisiran Study
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Shares of Alnylam Pharmaceuticals Inc. (ALNY - Free Report) increased 9.9% after it announced positive top-line results from the phase III -HELIOS-A study of vutrisiran, an investigational RNAi therapeutic in development for the treatment of transthyretin-mediated (ATTR) amyloidosis with polyneuropathy. The study met its primary and both secondary endpoints at nine months in patients with hereditary transthyretin (TTR)-mediated amyloidosis with polyneuropathy.
hATTR is an inherited, often fatal disease caused by mutations in the TTR gene.
Shares of Alnylam have increased 18.1% in the past year compared with the industry’s growth of 4.4%.
In the study, patients were randomized 3:1 to receive either 25mg of vutrisiran (N=122) via subcutaneous injection once every three months or 0.3 mg/kg of patisiran (N=42) via intravenous infusion once every three weeks (as a reference comparator) for 18 months. Vutrisiran met primary and all secondary endpoints, demonstrating statistically significant improvements in the progression of neuropathy, quality of life (QOL) and gait speed relative to placebo, after nine months. The primary endpoint of the phase III HELIOS-A study was the change from baseline in the modified Neuropathy Impairment Score (mNIS+7) at nine months as compared to historical placebo data from the APOLLO phase III study of patisiran.
Additionally, a majority of patients in the phase III HELIOS-A study showed reversal of disease manifestations with improvements in neuropathy impairment and QOL, relative to baseline.
In addition, vutrisiran treatment showed improvement compared to placebo on the exploratory cardiac biomarker endpoint, NT-proBNP (nominal p less than 0.05).
Based on the results from the HELIOS-A study, Alnylam intends to submit a new drug application (NDA) for vutrisiran this year in the United States and follow that up with regulatory filings in other countries. The company will seek approval in the European Union after an 18-month analysis, which is expected in late 2021.
Vutrisiran has been granted an Orphan Drug designation in the United States and the European Union for the treatment of ATTR amyloidosis. The drug has also been granted a Fast Track designation in the United States for the treatment of the polyneuropathy of hATTR amyloidosis in adults.
The company also initiated the HELIOS-B phase III study in patients with hereditary and wild-type ATTR amyloidosis with cardiomyopathy in November 2019 and enrollment is ongoing in the study.
Alkermes’ earnings per share estimates have increased from 48 cents to 52 cents for 2021 over the past 60 days. Shares of the company have increased 2% in the past year.
Halozyme’s earnings per share estimates have increased from 85 cents to 92 cents for 2020 and from $1.66 to $1.72 for 2021 over the past 60 days.
ASLAN’s loss per share estimates have narrowed from 42 cents to 40 cents for 2020 and from 60 cents to 57 cents for 2021 over the past 60 days.
It could become the mother of all technological revolutions. Apple sold a mere 1 billion iPhones in 10 years but a new breakthrough is expected to generate more than 27 billion devices in just 3 years, creating a $1.7 trillion market. Zacks has just released a Special Report that spotlights this fast-emerging phenomenon and 6 tickers for taking advantage of it. If you don't buy now, you may kick yourself in 2021.
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Alnylam (ALNY) Posts Positive Top-Line Data From Vutrisiran Study
Shares of Alnylam Pharmaceuticals Inc. (ALNY - Free Report) increased 9.9% after it announced positive top-line results from the phase III -HELIOS-A study of vutrisiran, an investigational RNAi therapeutic in development for the treatment of transthyretin-mediated (ATTR) amyloidosis with polyneuropathy. The study met its primary and both secondary endpoints at nine months in patients with hereditary transthyretin (TTR)-mediated amyloidosis with polyneuropathy.
hATTR is an inherited, often fatal disease caused by mutations in the TTR gene.
Shares of Alnylam have increased 18.1% in the past year compared with the industry’s growth of 4.4%.
In the study, patients were randomized 3:1 to receive either 25mg of vutrisiran (N=122) via subcutaneous injection once every three months or 0.3 mg/kg of patisiran (N=42) via intravenous infusion once every three weeks (as a reference comparator) for 18 months. Vutrisiran met primary and all secondary endpoints, demonstrating statistically significant improvements in the progression of neuropathy, quality of life (QOL) and gait speed relative to placebo, after nine months. The primary endpoint of the phase III HELIOS-A study was the change from baseline in the modified Neuropathy Impairment Score (mNIS+7) at nine months as compared to historical placebo data from the APOLLO phase III study of patisiran.
Additionally, a majority of patients in the phase III HELIOS-A study showed reversal of disease manifestations with improvements in neuropathy impairment and QOL, relative to baseline.
In addition, vutrisiran treatment showed improvement compared to placebo on the exploratory cardiac biomarker endpoint, NT-proBNP (nominal p less than 0.05).
Based on the results from the HELIOS-A study, Alnylam intends to submit a new drug application (NDA) for vutrisiran this year in the United States and follow that up with regulatory filings in other countries. The company will seek approval in the European Union after an 18-month analysis, which is expected in late 2021.
Vutrisiran has been granted an Orphan Drug designation in the United States and the European Union for the treatment of ATTR amyloidosis. The drug has also been granted a Fast Track designation in the United States for the treatment of the polyneuropathy of hATTR amyloidosis in adults.
The company also initiated the HELIOS-B phase III study in patients with hereditary and wild-type ATTR amyloidosis with cardiomyopathy in November 2019 and enrollment is ongoing in the study.
Zacks Rank & Stocks to Consider
Alnylam currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector include Alkermes Plc. ((ALKS - Free Report) ), Halozyme Therapeutics Inc. ((HALO - Free Report) ) and ASLAN Pharmaceuticals Ltd. (ASLN - Free Report) , each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Alkermes’ earnings per share estimates have increased from 48 cents to 52 cents for 2021 over the past 60 days. Shares of the company have increased 2% in the past year.
Halozyme’s earnings per share estimates have increased from 85 cents to 92 cents for 2020 and from $1.66 to $1.72 for 2021 over the past 60 days.
ASLAN’s loss per share estimates have narrowed from 42 cents to 40 cents for 2020 and from 60 cents to 57 cents for 2021 over the past 60 days.
Alnylam Pharmaceuticals, Inc. Price
Alnylam Pharmaceuticals, Inc. price | Alnylam Pharmaceuticals, Inc. Quote
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