Alnylam (ALNY) Upgraded To Buy On Solid Pipeline Growth

On Jul 11, Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY) was upgraded to a Zacks Rank #2 (Buy).

Why the Upgrade?

Alnylam’s key pipeline candidate, Fitusiran , aRNA interference (RNAi) therapeutic being developed for the treatment of hemophilia A and B and rare bleeding disorders (RBD), has been progressing well lately.

On Jul 10, Alnylam along with Sanofi, (NYSE:SNY) announced positive results from an ongoing phase II open-label extension (OLE) study evaluating fitusiran for the treatment of patients with hemophilia A and B, with or without inhibitors. In the phase II study, the patients were treated for up to 20 months. In fact, the safety and tolerability profile of fitusiran was maintained in the study.

Moreover, the once-monthly subcutaneous (SC) administration of fitusiran led to an 80% lowering of antithrombin (AT) with corresponding increases in thrombin generation. Also, in an exploratory post-hoc analysis of bleeding events, a median annualized bleeding rate (ABR) of one was achieved for all patients compared to zero for the subset of patients with inhibitors.

Last week, Alnylam commenced a phase III ATLAS study for fitusiran as well. The phase III study will assess the safety and efficacy of fitusiran in three separate trials, including patients with hemophilia A and B with or without inhibitors and patients receiving prophylactic therapy.

Notably, Alnylam’s progress with its other pipeline candidates has also been impressive. Patisiran, one of the most advanced candidates, has progressed successfully so far. Alnylam is currently evaluating patisiran in the phase III APOLLO study in ATTR-PN patients. Alnylam plans to submit regulatory application for patisiran both in the U.S. and the EU by 2017 end.

Moreover, the company is evaluating inclisiran (formerly known as PCSK9si or ALN-PCSsc) in phase II ORION studies for hypercholesterolemia.

Other candidates in its pipeline include ALN-CC5 (phase I/II; complement-mediated diseases), givosiran (phase I – acute hepatic porphyrias and ALN-HBV (phase I/II – HBV infection. Successful development and subsequent approval of these candidates will be a huge boost for the company.

Alnylam plans to advance givosiran and inclisiran into phase III program in 2017. A deep pipeline with most candidates under its promising RNAi technology poises the company for growth.

The company’s RNAi technology has allowed it to ink collaborations with leading pharmaceutical and life sciences companies like Novartis (NYSE:NVS) , Roche (OTC:RHHBY) , Monsanto (NYSE:MON) and Sanofi. These deals not only provide it with funds but also take its RNAi technology outside the core focus area.

Other than a strong rank, Alnylam has witnessed favorable estimate movement and share price growth lately.

Although the company’s share price declined last year, it is up so far this year.

In fact, the stock surged 111% this year so far compared with the Zacks classified Medical - Biomedical and Genetics industry’s gain of 7.1%.

Loss estimates for Alnylam narrowed 0.2% and 0.3% for 2017 and 2018, respectively, over the past 60 days. Also, the company’s earnings performance has been pretty impressive, as it has delivered positive surprises in two of the trailing four quarters. In fact, the average earnings beat over the last four quarters is 3.69%.

You can see the complete list of today’s Zacks Rank #1 (Strong Buy) stocks here.

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