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Alnylam (ALNY) Files MAA to EMA for Rare Disease Drug Vutrisiran

·2-min read

Alnylam Pharmaceuticals, Inc. ALNY 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%.

Zacks Investment Research
Zacks Investment Research


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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, Vertex Pharmaceuticals Incorporated VRTX and Corvus Pharmaceuticals, Inc. CRVS, 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.


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Alnylam Pharmaceuticals, Inc. (ALNY) : Free Stock Analysis Report

Vertex Pharmaceuticals Incorporated (VRTX) : Free Stock Analysis Report

Corvus Pharmaceuticals, Inc. (CRVS) : Free Stock Analysis Report

Spero Therapeutics, Inc. (SPRO) : Free Stock Analysis Report

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