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Alnylam's Givosiran Gets Breakthrough Therapy Status by FDA

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Alnylam Pharmaceuticals, Inc.ALNY announced that it has received Breakthrough Therapy designation from the FDA for pipeline candidate givosiran (ALN-AS1), for the prophylaxis of attacks in patients with acute hepatic porphyria (AHP).

We note that Givosiran is being evaluated for the treatment of acute hepatic porphyrias, including acute intermittent porphyria (AIP).

A look at Alnylam's year-to-date share price movement shows that the stock has outperformed the Zacks classified Medical-Biomed/Genetics industry. Share price has increased 74.8% year to date against the industry's decline of 0.5%.

The Breakthrough Therapy designation was based on the encouraging results from the ongoing phase I study of givosiran. Findings demonstrated robust and durable reduction in the occurrence of porphyria attacks. Updated results from this trial will be provided in an oral presentation on Jun 26, 2017 at the International Congress on Porphyrins and Porphyrias (ICPP).

Breakthrough Therapy Designation from the FDA will expedite the development and review of drugs that are intended to treat serious diseases and should provide access of the drug to patients as soon as possible.

Givosiran has also been granted Orphan Drug Designations in both the E.U. and the U.S. for the treatment of acute hepatic porphyrias. In Mar 2017, the European Medicines Agency (EMA) granted givosiran PRIME Designation for accelerated assessment for the treatment of porphyria based on positive data from the phase I study. The company plans to initiate the phase III study with givosiran in late 2017.

A potential approval will significantly boost the growth prospects of the company.

Alnylam Pharmaceuticals, Inc. Price

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

Zacks Rank and Stocks to Consider

Alnylam carries a Zacks Rank#3 (Hold). Some better ranked stocks in the health care sector include VIVUS, Inc. VVUS , MEI Pharma, Inc. MEIP and Aeglea BioTherapeutics AGLE . While VIVUS and MEI Pharma sport a Zacks Rank #1 (Strong Buy), Aeglea carries a Zacks Rank #2 (Buy). You can see the complete list of today's Zacks #1 Rank stocks here .

VIVUS' loss per share estimates narrowed from 50 cents to 39 cents for 2017 over the last 30 days. The company posted positive earnings surprises in all of the four trailing quarters, with an average beat of 233.69%.

MEI Pharma's estimates narrowed from loss per share of 1 cent to gain per share of 1 cent for 2017 over the last 30 days. The company posted positive earnings surprises in three of the four trailing quarters, with an average beat of 66.56%.

Aeglea's loss per share estimates narrowed from $3.64 to $2.48 for 2017 over the last 60 days. The company posted positive earnings surprises in three of the four trailing quarters, with an average beat of 20.75%.

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


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

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