We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Alnylam (ALNY) Files MAA to EMA for Rare Disease Drug Vutrisiran
Read MoreHide Full Article
Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) announced that it has submitted a marketing authorization application (“MAA”) to the European Medicines Agency (“EMA”), seeking approval of its investigational RNAi therapeutic, vutrisiran, for the treatment of adult patients with polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis.
If approved in the European Union, vutrisiran might become a new, subcutaneously administered, once-quarterly treatment option for the given patient population.
Alnylam also plans to submit regulatory filings for vutrisiran in Brazil and Japan, later in 2021.
Shares of Alnylam have rallied 43% so far this year compared with the industry’s rise of 0.8%.
Image Source: Zacks Investment Research
In June 2021, the FDA accepted the new drug application for vutrisiran to treat adult patients with polyneuropathy of hATTR amyloidosis. A decision from the regulatory body is expected on Apr 14, 2022.
Both the FDA and the EMA have granted Orphan Drug designation to vutrisiran for the treatment of ATTR amyloidosis.
We remind investors that Alnylam’s Onpattro is already approved for the treatment of polyneuropathy of hATTR amyloidosis. The injection recorded sales of $215.8 million in the first six months of 2021, up 62% year over year, driven by new patient demand.
Hence, the potential approval of vutrisiran should help Alnylam strengthen its portfolio and drive growth further in the days ahead.
Image: Bigstock
Alnylam (ALNY) Files MAA to EMA for Rare Disease Drug Vutrisiran
Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) announced that it has submitted a marketing authorization application (“MAA”) to the European Medicines Agency (“EMA”), seeking approval of its investigational RNAi therapeutic, vutrisiran, for the treatment of adult patients with polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis.
If approved in the European Union, vutrisiran might become a new, subcutaneously administered, once-quarterly treatment option for the given patient population.
Alnylam also plans to submit regulatory filings for vutrisiran in Brazil and Japan, later in 2021.
Shares of Alnylam have rallied 43% so far this year compared with the industry’s rise of 0.8%.
Image Source: Zacks Investment Research
In June 2021, the FDA accepted the new drug application for vutrisiran to treat adult patients with polyneuropathy of hATTR amyloidosis. A decision from the regulatory body is expected on Apr 14, 2022.
Both the FDA and the EMA have granted Orphan Drug designation to vutrisiran for the treatment of ATTR amyloidosis.
We remind investors that Alnylam’s Onpattro is already approved for the treatment of polyneuropathy of hATTR amyloidosis. The injection recorded sales of $215.8 million in the first six months of 2021, up 62% year over year, driven by new patient demand.
Hence, the potential approval of vutrisiran should help Alnylam strengthen its portfolio and drive growth further in the days ahead.
Zacks Rank & Stocks to Consider
Alnylam currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector include Spero Therapeutics, Inc. (SPRO - Free Report) , Vertex Pharmaceuticals Incorporated (VRTX - Free Report) and Corvus Pharmaceuticals, Inc. (CRVS - 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.
Spero Therapeutics’ loss per share estimates have narrowed 8.2% for 2021 and 10.6% for 2022 over the past 60 days.
Vertex’s earnings estimates have been revised 10.2% upward for 2021 and 7.1% upward for 2022 over the past 60 days.
Corvus Pharmaceuticals’ loss per share estimates have narrowed 24.4% for 2021 and 21.4% for 2022 over the past 60 days.