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Alnylam Gets European Nod for First-Ever RNAi Therapeutic

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Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) announced that the European Commission (EC) has granted marketing authorization for Onpattro (patisiran), the first ever RNA interference (RNAi) therapeutic, for the treatment of hereditary transthyretin-mediated (hATTR) amyloidosis in adults with stage 1 or stage 2 polyneuropathy. The European Medicines Agency reviewed patisiran under the accelerated assessment procedure.

The European approval of Onpattro was based on the results from the APOLLO study that met its primary as well as all secondary endpoints

hATTR amyloidosis is a rare, inherited, rapidly progressive and life-threatening disease. The approval of Onpattro marks the arrival of a first-of-its kind treatment option for a rare and devastating disease with limited treatment options. The approval also represents an entirely new approach to treating patients with polyneuropathy in hATTR amyloidosis.

We remind investors that Onpattro was approved by the FDA in the United States in August. The drug is the first and only FDA approved therapy for the treatment of the polyneuropathy of hATTR amyloidosis in adults.

Onpattro, which is the first approved drug in Alnylam’s portfolio, is expected to be drive revenue for the company.

So far this year, shares of Alnylam declined 4.1% compared with the industry’s fall of 1.7%.

Alnylam had a partnership with Sanofi (SNY - Free Report) for Onpattro. The agreement was amended in January 2018 and per the amended agreement, Alnylam will fund all development and commercialization costs for Onpattro. Sanofi intends to substantially complete the transition of its Onpattro activities in regions outside the United States, Canada, and Western Europe, consistent with the original scope of its license rights to Onpattro.

 Zacks Rank & Stocks to Consider

Alnylam has a Zacks Rank #3 (Hold).

Some better-ranked stocks from the same space worth considering are Gilead Sciences Inc. (GILD - Free Report) and Ligand Pharmaceuticals Inc. (LGND - Free Report) . Both the stocks carry a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Gilead’s earnings per share estimates have increased from $6.11 to $6.57 for 2018 and from $6.36 to $6.48 for 2019 over the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 6.43%. The stock has rallied 6.5% so far this year.

Ligand’s earnings per share estimates moved up from $4.93 to $5.64 for 2018 and from $5.39 to $5.59 for 2019 in the last 30 days. The company delivered a positive earnings surprise in all of the trailing four quarters with an average beat of 59.54%. Share price of the company has increased 88.1% year to date.

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