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Sangamo's (SGMO) Hemophilia A Drug Gets Fast-Track Status

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Sangamo Therapeutics, Inc. (SGMO - Free Report) announced that the FDA has granted fast-track designation to pipeline candidate, SB-525.

Sangamo’s shares declined 145.9% year to date compared with the Zacks classified Medical - Biomedical and Genetics industry’s gain of 2.1%.

SB-525 is Sangamo’s clinical stage cDNA gene therapy candidate for hemophilia A.

The fast-track designation from the FDA will facilitate the development and expedite the review of drugs and biologics to treat serious conditions and fill an unmet medical need.

We remind investors that SB-525 already enjoys orphan drug status in the U.S. The FDA has cleared an Investigational New Drug application for this program, and a phase I/II clinical trial evaluating SB-525 in adults with hemophilia A is expected to open and begin screening subjects for enrolment by the end of second-quarter 2017. Data from this study are expected in late 2017 or early 2018.

SB-525 is one of Sangamo's four lead product candidates. The candidate is being developed as part of an exclusive, global collaboration and license agreement with Pfizer Inc. (PFE - Free Report) . Earlier in this month, Sangamo announced an exclusive, global collaboration and license agreement with Pfizer for the development and commercialization of gene therapy programs for Hemophilia A.

Hemophilia A is a monogenic, rare bleeding disorder in which the blood does not clot normally. As per the Centers for Disease Control and Prevention, hemophilia occurs in about one of every 5,000 male births, with an estimated 20,000 males in the U.S. living with the disorder.

Meanwhile, Sangamo also has a collaboration agreement with Shire International GmbH to develop therapeutics for Huntington's disease.

Zacks Rank & Key Picks

Sangamo currently carries a Zacks Rank #3 (Hold). 

A better-ranked stock in the health care sector is VIVUS, Inc. which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

VIVUS’s 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%.

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