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Alnylam Commences Phase III Study for Hemophilia Candidate


Alnylam Pharmaceuticals, Inc. ALNY and Sanofi’s SNY announced that it has commenced phase III ATLAS study for its candidate fitusiran. Fitusiran is an investigational RNA interference (RNAi) therapeutic being developed for the treatment of hemophilia and rare bleeding disorders (RBD).

Shares of the company have outperformed the Zacks classified Medical – Biomedical and Genetics industry so far this year. The stock has soared 124.5%, while the industry gained 7%.

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. Two of these studies include ATLAS-INH and ATLAS-A/B, which will include patients with hemophilia A or B with inhibitors receiving prior on-demand therapy. The duration for both these studies will be nine months.

The third study, ATLAS-PPX, will enroll about 100 patients with hemophilia A or B with or without inhibitors receiving prophylaxis therapy as prior standard of care. Top-line data from the ATLAS trials are expected in mid-to-late 2019.

Notably, Alnylam is a development-stage biopharmaceutical company focused on the development of novel therapeutics based on RNA interference (RNAi). The company’s progress with its pipeline candidates has been impressive. Moving ahead, it expects 2017 to be a pivotal year with its first phase III data read out from the APOLLO study for its late-stage pipeline candidate patisiran.

Additionally, the company plans to advance two additional programs, givosiran and inclisiran, into late-stage trials in 2017. Givosiran is in development for the treatment of acute hepatic porphyrias and inclisiran is being evaluated for the treatment of hypercholesterolemia.

Last week, another pharmaceutical company, Shire plc SHPG, announced that it has filed an investigational new drug (IND) application with the FDA, seeking approval for its recombinant factor VIII (FVIII) gene therapy candidate, SHP654, for the treatment of patients with Hemophilia A. The gene therapy developed by the company treats hemophilia A by selectively targeting the liver.

Zacks Rank & Stocks to Consider

Alnylam currently carries a Zacks Rank #3 (Hold). A better-ranked health care stock is Enzo Biochem, Inc. ENZ, which sports Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Enzo Biochem’s loss per share estimates narrowed from 12 cents to 7 cents for 2017, and from 11 cents to 3 cents for 2018, over the last 30 days. The company delivered positive earnings surprises in all the trailing four quarters, with an average beat of 55.83%. The share price of the company has increased 62.4% year to date.

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