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Alnylam's Shares Up as Onpattro Gets FDA and EU Approvals

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Shares of Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) have gained 31.8% in the past month. However, shares of Alnylam declined 3.5% year to date compared with the industry’s decline of 1.7%.

 

The factors that have led to the price rise are as follows:

Last month, the company received a major boost when the FDA approved its lead candidate, Onpattro (patisiran) lipid complex injection, a first-of-its-kind RNA interference (RNAi) therapeutic, for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults. This was shortly followed by the European approval of the same. Onpattro, being the first approved drug in Alnylam’s portfolio, should drive growth for the company. The drug will be an important treatment option for people suffering from this often fatal disease.

Alnylam had a partnership with Sanofi (SNY - Free Report) for Onpattro, which was amended in January 2018. Per the amended agreement, Alnylam will fund all development and commercialization costs for Onpattro. Sanofi intends to 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.

The company is also evaluating several other candidates. Alnylam expects to initiate a phase III pivotal study program in late 2018 for ALN-TTRsc02, a once-quarterly, subcutaneously administered investigational RNAi therapeutic in development, for the treatment of ATTR amyloidosis. In June 2018, ALN-TTRsc02 received the Orphan Drug designation from the FDA.

The company along with its partner The Medicines Company (MDCO - Free Report) is evaluating inclisiran in phase III ORION studies for hypercholesterolemia. The company is also conducting fitusiran's ATLAS phase III study for the treatment of patients with hemophilia A or B with and without inhibitors.  Alnylam expects phase III readouts for fitusiran and inclisiran in 2019, leading to potential approvals in 2020.

Alnylam also expects to initiate the lumasiran phase III study for the treatment of primary hyperoxaluria type 1 (PH1) in 2018, with results expected in late 2019 supporting a potential NDA filing in early 2020. Lumisiran is an investigational RNAi therapeutic targeting glycolate oxidase (GO).

Successful development and subsequent approval of these candidates will be a huge boost for the company.

Zacks Rank & Stock to Consider

Alnylam has a Zacks Rank #3 (Hold).

A better-ranked stock in the biotech sector is Gilead Sciences Inc. (GILD - Free Report) carrying 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 5.7% so far this year.

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