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Alnylam's (ALNY) Rare Disease Drug Amvuttra Gets EC Nod
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Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) announced that the European Commission (EC) has granted marketing authorization to its RNAi therapeutic Amvuttra (vutrisiran) for the treatment of hereditary transthyretin-mediated (hATTR) amyloidosis in adult patients with stage 1 or stage 2 polyneuropathy.
The EC nod was based on positive 18-month data from the phase III HELIOS-A study that evaluated Amvuttra for the given indication.
Data from the same showed that treatment with Amvuttra significantly improved the signs and symptoms of hATTR amyloidosis, with more than 50% of the patients experiencing halting or reversal of their polyneuropathy manifestations.
The approval in Europe was expected as the European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion recommending the approval for Amvuttra in July 2022.
Shares of Alnylam have rallied 25% this year so far against the industry’s decline of 24.6%.
Image Source: Zacks Investment Research
The FDA approved Amvuttra in June for the treatment of adult patients with polyneuropathy of hATTR amyloidosis. hATTR is an inherited disease, often proved to be fatal, caused by mutations in the TTR gene.
Amvuttra is approved as a subcutaneous injection to be administered once every three months (quarterly) for the given indication.
Both the FDA and the EMA granted Orphan Drug designation to vutrisiran for the treatment of ATTR amyloidosis.
Regulatory applications seeking approval for vutrisiran to address a similar indication are also under review in Japan and Brazil.
Investors must note that Alnylam’s marketed product Onpattr, is already approved for treating polyneuropathy of hATTR amyloidosis. The injection recorded sales of $290.4 million in the first six months of 2022, up around 34.5% year over year, driven by new patient demand.
Aptose Biosciences’ loss per share estimates has narrowed 14% for 2022 and 10% for 2023 in the past 60 days.
Earnings of Aptose Biosciences surpassed estimates in three of the trailing four quarters and missed the mark on the remaining occasion. APTO delivered an earnings surprise of 2.23%, on average.
Atara Biotherapeutics’ loss per share estimates has narrowed 43.2% for 2022 and 21.3% for 2023 in the past 60 days.
Earnings of Atara Biotherapeutics surpassed estimates in three of the trailing four quarters and missed the mark on the remaining occasion. ATRA delivered an earnings surprise of 4.83%, on average.
ORIC Pharmaceuticals’ loss per share estimates has narrowed 8.6% for 2022 and 22% for 2023 in the past 60 days.
Earnings of ORIC Pharmaceuticals surpassed estimates in three of the trailing four quarters and missed the same on the remaining occasion. ORIC delivered an earnings surprise of 8.85%, on average.
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Alnylam's (ALNY) Rare Disease Drug Amvuttra Gets EC Nod
Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) announced that the European Commission (EC) has granted marketing authorization to its RNAi therapeutic Amvuttra (vutrisiran) for the treatment of hereditary transthyretin-mediated (hATTR) amyloidosis in adult patients with stage 1 or stage 2 polyneuropathy.
The EC nod was based on positive 18-month data from the phase III HELIOS-A study that evaluated Amvuttra for the given indication.
Data from the same showed that treatment with Amvuttra significantly improved the signs and symptoms of hATTR amyloidosis, with more than 50% of the patients experiencing halting or reversal of their polyneuropathy manifestations.
The approval in Europe was expected as the European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion recommending the approval for Amvuttra in July 2022.
Shares of Alnylam have rallied 25% this year so far against the industry’s decline of 24.6%.
Image Source: Zacks Investment Research
The FDA approved Amvuttra in June for the treatment of adult patients with polyneuropathy of hATTR amyloidosis. hATTR is an inherited disease, often proved to be fatal, caused by mutations in the TTR gene.
Amvuttra is approved as a subcutaneous injection to be administered once every three months (quarterly) for the given indication.
Both the FDA and the EMA granted Orphan Drug designation to vutrisiran for the treatment of ATTR amyloidosis.
Regulatory applications seeking approval for vutrisiran to address a similar indication are also under review in Japan and Brazil.
Investors must note that Alnylam’s marketed product Onpattr, is already approved for treating polyneuropathy of hATTR amyloidosis. The injection recorded sales of $290.4 million in the first six months of 2022, up around 34.5% year over year, driven by new patient demand.
Zacks Rank & Stocks to Consider
Alnylam currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Aptose Biosciences Inc. (APTO - Free Report) , Atara Biotherapeutics, Inc. (ATRA - Free Report) and ORIC Pharmaceuticals, Inc. (ORIC - Free Report) , all carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Aptose Biosciences’ loss per share estimates has narrowed 14% for 2022 and 10% for 2023 in the past 60 days.
Earnings of Aptose Biosciences surpassed estimates in three of the trailing four quarters and missed the mark on the remaining occasion. APTO delivered an earnings surprise of 2.23%, on average.
Atara Biotherapeutics’ loss per share estimates has narrowed 43.2% for 2022 and 21.3% for 2023 in the past 60 days.
Earnings of Atara Biotherapeutics surpassed estimates in three of the trailing four quarters and missed the mark on the remaining occasion. ATRA delivered an earnings surprise of 4.83%, on average.
ORIC Pharmaceuticals’ loss per share estimates has narrowed 8.6% for 2022 and 22% for 2023 in the past 60 days.
Earnings of ORIC Pharmaceuticals surpassed estimates in three of the trailing four quarters and missed the same on the remaining occasion. ORIC delivered an earnings surprise of 8.85%, on average.