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Gilead (GILD) HCV Therapy Application Validated in Europe

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Gilead Sciences, Inc.GILD announced that its Marketing Authorization Application (MAA) for experimental direct-acting antiviral (DAA) of once-daily, single tablet regimen (STR) of Sovaldi, velpatasvir 100 mg and voxilaprevir 100 mg (SOF/VEL/VOX) for the treatment of chronic hepatitis C virus (HCV)-infected patients has been fully validated.

Shares of Gilead have underperformed the Zacks classified industry in the last one year with the stock losing 21.6% during this period, compared with the industry's decline of 12.8%.

Shares of Gilead have underperformed the Zacks classified Medical-Biomedical and Genetics industry in the last one year with the stock losing 21.6% during this period, compared with the industry's decline of 12.8%.

The application is under assessment by the European Medicines Agency (EMA).The application will be reviewed by the EMA under an accelerated procedure given the need for advanced HCV treatments.

We remind investors that in Dec 2016 the company had filed a regulatory application in the U.S., seeking approval for a once-daily fixed-dose combination of Sovaldi/velpatasvir plus voxilaprevir for the treatment of DAA-experienced chronic HCV-infected patients.

Gilead is known for its presence in the HCV market because of its blockbuster drugs, Sovaldi and Harvoni. The HCV portfolio got a huge a boost when Epclusa gained approval in both the U.S. and the EU in 2016 to become the first and only all-oral, pan-genotypic, STR consisting of Sovaldi and velpatasvir (an NS5A inhibitor), for the treatment of adults with genotype 1-6 chronic HCV infection.

Gilead is working on bringing new HCV therapies to market. If the DAA is approved, the combination would be the first once-daily STR available as a salvage therapy for patients infected with HCV genotype 1-6 who have failed prior treatment with DAA regimens including NS5A inhibitors.

However, we note that Gilead's HCV treatments face competition from AbbVie's ABBV Viekira Pak and Viekira XR, Bristol-Myers' BMY Daklinza among others.

Gilead Sciences currently carries a Zacks Rank #3 (Hold).

Gilead Sciences Inc. Price and Consensus

Gilead Sciences Inc. Price and Consensus | Gilead Sciences Inc. Quote

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A better-ranked stock in this industry is Sucampo Pharmaceuticals SCMP . The company currently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today's Zacks #1 Rank stocks here .

Sucampo's estimates increased from $1.58 to $1.74 for 2017 over the last 30 days. The company posted a positive surprise in all of the four trailing quarters with an average beat of 35.55%.

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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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