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GlaxoSmithKline plc (GSK - Free Report) announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency has a positive opinion, recommending a marketing approval for its shingles vaccine, Shingrix. A final decision from the EU is expected in April 2018.
The company filed a marketing authorization application for Shingrix in the EU for prevention of shingles (herpes zoster) and post-herpetic neuralgia (PHN) in older patients (aged 50 years or above) in November 2016.
Notably, Shingrix was already approved in the United States and Canada for preventing shingles. The candidate is also under review in Australia and Japan for the same indication.
Glaxo’s shares have underperformed the industry in a year’s time. The stock has inched up 0.1% compared with the industry’s 29% rally.
The committee’s positive feedback was based on data from a clinical trial program comprising two phase III studies — ZOE-50 and ZOE-70 — evaluating the safety, efficacy and immunogenicity of the candidate in more than 37,000 individuals. Significantly, Shingrix is the only shingles vaccine to achieve 90% efficacy or more in adults aged 50 and above.
The vaccine is also being evaluated in immuno-compromised patient populations, including solid and hematological cancer patients, hematopoietic stem cell and renal transplant recipients as well as HIV-infected people.
Importantly, Glaxo expects its line-up of new pharmaceutical and vaccine products including potential contributions from the Shingrix to deliver sales of £6 billion per annum by 2018.
Per the company’s press release, around one in three people worldwide is vulnerable to develop shingles in a lifetime with increasing age. Moreover, approximately 1.7 million people in Europe are affected by Shingles, leading to a painful and potentially serious condition. Additionally, 30% of shingle patients develops PNH. Hence, the potential market opportunity to prevent this serious life-threatening disease adopting precautionary measures, is huge in the EU.
Glaxo carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are Exelixis, Inc. (EXEL - Free Report) , XOMA Corporation (XOMA - Free Report) and Sucampo Pharmaceuticals, Inc. . While Exelixis and XOMA sport a Zacks Rank #1 (Strong Buy), Sucampo carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Exelixis’ earnings per share estimates have been revised upward from 72 cents to 77 cents for 2018 over the last 60 days. The company pulled off a positive earnings surprise in each of the trailing four quarters with an average beat of 572.92%. Share price of the company has soared 65.6% in a year’s time.
XOMA’s loss per share estimates have narrowed from 99 cents to 42 cents for 2018 over the last 60 days. The company came up with an average beat of 47.92%. The stock has skyrocketed 693.1% in the last 12 months.
Sucampo delivered a positive surprise in three of the last four quarters with an average beat of 15.63%. The company’s share price has surged 67% in a year.
Zacks Top 10 Stocks for 2018
In addition to the stocks discussed above, would you like to know about our 10 finest buy-and-hold tickers for the entirety of 2018?
Last year's 2017 Zacks Top 10 Stocks portfolio produced double-digit winners, including FMC Corp. and VMware which racked up stellar gains of +67.9% and +61%. Now a brand-new portfolio has been handpicked from over 4,000 companies covered by the Zacks Rank. Don’t miss your chance to get in on these long-term buys.
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Glaxo's Shingles Vaccine Shingrix Gets Positive CHMP Opinion
GlaxoSmithKline plc (GSK - Free Report) announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency has a positive opinion, recommending a marketing approval for its shingles vaccine, Shingrix. A final decision from the EU is expected in April 2018.
The company filed a marketing authorization application for Shingrix in the EU for prevention of shingles (herpes zoster) and post-herpetic neuralgia (PHN) in older patients (aged 50 years or above) in November 2016.
Notably, Shingrix was already approved in the United States and Canada for preventing shingles. The candidate is also under review in Australia and Japan for the same indication.
Glaxo’s shares have underperformed the industry in a year’s time. The stock has inched up 0.1% compared with the industry’s 29% rally.
The committee’s positive feedback was based on data from a clinical trial program comprising two phase III studies — ZOE-50 and ZOE-70 — evaluating the safety, efficacy and immunogenicity of the candidate in more than 37,000 individuals. Significantly, Shingrix is the only shingles vaccine to achieve 90% efficacy or more in adults aged 50 and above.
The vaccine is also being evaluated in immuno-compromised patient populations, including solid and hematological cancer patients, hematopoietic stem cell and renal transplant recipients as well as HIV-infected people.
Importantly, Glaxo expects its line-up of new pharmaceutical and vaccine products including potential contributions from the Shingrix to deliver sales of £6 billion per annum by 2018.
Per the company’s press release, around one in three people worldwide is vulnerable to develop shingles in a lifetime with increasing age. Moreover, approximately 1.7 million people in Europe are affected by Shingles, leading to a painful and potentially serious condition. Additionally, 30% of shingle patients develops PNH. Hence, the potential market opportunity to prevent this serious life-threatening disease adopting precautionary measures, is huge in the EU.
GlaxoSmithKline PLC Price
GlaxoSmithKline PLC Price | GlaxoSmithKline PLC Quote
Zacks Rank & Key Picks
Glaxo carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are Exelixis, Inc. (EXEL - Free Report) , XOMA Corporation (XOMA - Free Report) and Sucampo Pharmaceuticals, Inc. . While Exelixis and XOMA sport a Zacks Rank #1 (Strong Buy), Sucampo carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Exelixis’ earnings per share estimates have been revised upward from 72 cents to 77 cents for 2018 over the last 60 days. The company pulled off a positive earnings surprise in each of the trailing four quarters with an average beat of 572.92%. Share price of the company has soared 65.6% in a year’s time.
XOMA’s loss per share estimates have narrowed from 99 cents to 42 cents for 2018 over the last 60 days. The company came up with an average beat of 47.92%. The stock has skyrocketed 693.1% in the last 12 months.
Sucampo delivered a positive surprise in three of the last four quarters with an average beat of 15.63%. The company’s share price has surged 67% in a year.
Zacks Top 10 Stocks for 2018
In addition to the stocks discussed above, would you like to know about our 10 finest buy-and-hold tickers for the entirety of 2018?
Last year's 2017 Zacks Top 10 Stocks portfolio produced double-digit winners, including FMC Corp. and VMware which racked up stellar gains of +67.9% and +61%. Now a brand-new portfolio has been handpicked from over 4,000 companies covered by the Zacks Rank. Don’t miss your chance to get in on these long-term buys.
Access Zacks Top 10 Stocks for 2018 today >>