Alnylam Gets European Nod for First-Ever RNAi Therapeutic

Shutterstock photo

Alnylam Pharmaceuticals, Inc.  ALNY 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 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.

Alnylam Pharmaceuticals, Inc. Price

Alnylam Pharmaceuticals, Inc. Price | Alnylam Pharmaceuticals, Inc. Quote

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 and Ligand Pharmaceuticals Inc. LGND . 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.

5 Companies Verge on Apple-Like Run

Did you miss Apple's 9X stock explosion after they launched their iPhone in 2007? Now 2018 looks to be a pivotal year to get in on another emerging technology expected to rock the market.

Demand could soar from almost nothing to $42 billion by 2025. Reports suggest it could save 10 million lives per decade which could in turn save $200 billion in U.S. healthcare costs.

A bonus Zacks Special Report names this breakthrough and the 5 best stocks to exploit it. Like Apple in 2007, these companies are already strong and coiling for potential mega-gains.

Click to see them right now >>

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

Sanofi (SNY): Free Stock Analysis Report

Ligand Pharmaceuticals Incorporated (LGND): Free Stock Analysis Report

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

Gilead Sciences, Inc. (GILD): Free Stock Analysis Report

To read this article on Zacks.com click here.

Zacks Investment Research

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

This article appears in: Investing , Business , Stocks
Referenced Symbols: SNY , LGND , ALNY , GILD

More from Zacks.com




Equity Research

Research Brokers before you trade

Want to trade FX?