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Glaxo (GSK) Files Regulatory Application for Shingrix in EU

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GlaxoSmithKline plc GSK announced that it has filed a Marketing Authorisation Application (MAA) in the EU for its shingles vaccine candidate, Shingrix.

The company is seeking an approval of the vaccine for intramuscularly use in two doses, with a two- to six-month interval between doses, for the prevention of herpes zoster (shingles) in people aged 50 years and above.

The regulatory submission was based on data from a clinical trial program comprising two phase III studies – ZOE-50 and ZOE-70 – that evaluated the safety, efficacy and immunogenicity of the candidate in more than 37,000 individuals. Results showed that, in addition to reducing the incidence of shingles, the candidate was able to reduce the overall incidence of postherpetic neuralgia.

In Oct 2016, Glaxo filed a regulatory application for Shingrix vaccine for the prevention of shingles in the U.S. Moreover, a regulatory application was filed in Canada this month. In addition, the company plans to file regulatory application for Shingrix in Japan in 2017.

Approval of the candidate for the prevention of shingles and the pain associated with it will be a positive for the eligible patient population as well as the company.

Meanwhile, Glaxo is conducting a study to evaluate revaccination in subjects who were previously vaccinated against shingles with the currently available live-attenuated vaccine. Shingrix is also being evaluated in immuno-compromised patient populations, including solid and hematological cancer patients, hematopoietic stem cell and renal transplant recipients and HIV-infected people.

These studies are expected to provide additional information on the efficacy and safety profile of the candidate along with its potential to stimulate immune responses in individuals who are at high risk of shingles.

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Zacks Rank & Key Picks

Glaxo currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Cambrex Corporation CBM, Heska Corporation HSKA and Vanda Pharmaceuticals, Inc. VNDA. Each of these stocks sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Cambrex’s earnings estimates increased from $2.46 to $2.55 for 2016 and from $2.91 to $3.06 for 2017 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 19.78%. Its share price has increased 6.2% year to date.

Heska’s earnings estimates have increased from $1.13 to $1.35 for 2016 and from $1.38 to $1.53 for 2017 over the last 60 days. The company posted a positive earnings surprise in all of the four trailing quarters with an average beat of 301.64%. Its share price has surged 71.5% year to date.

Vanda’s loss estimates narrowed from 68 cents to 56 cents for 2016, while its earnings estimates have increased from 16 cents to 17 cents for 2017 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average positive surprise of 56.65%. Its share price has surged 85.8% year to date.

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