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Glaxo Seeks EU Approval for Two-Drug Regimen in First-Line HIV
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GlaxoSmithKline (GSK - Free Report) announced that its HIV-focused company, ViiV Healthcare submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for a single-tablet, two-drug regimen of dolutegravir (Tivicay) and lamivudine (Epivir) for the treatment of HIV-1 infection.
ViiV Healthcare was established by Glaxo and Pfizer (PFE - Free Report) in 2009. After certain amendments in Oct 2012, Shionogi joined as a shareholder.
Shares of Glaxo have outperformed the industry so far this year. The stock has gained 10.0% comparing favorably with the industry’s 6.0% growth.
The submission is based on data from the global GEMINI 1 & 2 studies that included more than 1400 HIV-1 infected adults. The two phase III studies — GEMINI-1 and GEMINI-2 — evaluated the two-drug regimen in treatment naïve who have not received prior antiviral therapy, HIV-1 infected adults compared to a three-drug regimen of dolutegravir plus tenofovir alafenamide fumarate and emtricitabine.
The studies demonstrated that the dolutegravir and lamivudine regimen was non-inferior to the standard three-drug regimen in HIV control. This means a two-drug HIV regimen can control HIV in treatment-naïve patients as effectively as a three-drug regimen.
The company expects to file a new drug application (NDA) for this single-tablet regimen in October, using a priority review voucher.
We remind that Glaxo’s HIV portfolio includes Juluca, which is the first two-drug regimen that reduces the number of medicines HIV patients take without compromising on the efficacy of a conventional three-drug regimen. Juluca is developed and marketed by Glaxo in partnership with Johnson and Johnson (JNJ - Free Report) . Juluca received the FDA approval in November last year.
Last month, ViiV Healthcare and partner Johnson and Johnson announced positive headline results from phase III ATLAS study, evaluating another two-drug HIV regimen (2DR). The ATLAS study results showed that the combination of long-acting Edurant (rilpivirine) marketed by Johnson and Johnson and cabotegravir being developed by ViiV Healthcare injected once a month had similar efficacy to a standard of care, daily, oral three-drug regimen at Week 48. The study met its primary endpoint of non-inferiority.
Lilly’s earnings per share estimates have increased from $5.16 to $5.47 for 2018 and from $5.56 to $5.73 for 2019 over the past 60 days. The company delivered a positive earnings surprise in all of the trailing four quarters with an average beat of 10.15%. The stock has rallied 25.3% year to date.
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Much like petroleum 150 years ago, lithium battery power is set to shake the world, creating millionaires and reshaping geo-politics. Soon electric vehicles (EVs) may be cheaper than gas guzzlers. Some are already reaching 265 miles on a single charge. With battery prices plummeting and charging stations set to multiply, revenues that were already at $31 billion in 2016 are expected to blast to over $67 billion by the end of 2022.
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Glaxo Seeks EU Approval for Two-Drug Regimen in First-Line HIV
GlaxoSmithKline (GSK - Free Report) announced that its HIV-focused company, ViiV Healthcare submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for a single-tablet, two-drug regimen of dolutegravir (Tivicay) and lamivudine (Epivir) for the treatment of HIV-1 infection.
ViiV Healthcare was established by Glaxo and Pfizer (PFE - Free Report) in 2009. After certain amendments in Oct 2012, Shionogi joined as a shareholder.
Shares of Glaxo have outperformed the industry so far this year. The stock has gained 10.0% comparing favorably with the industry’s 6.0% growth.
The submission is based on data from the global GEMINI 1 & 2 studies that included more than 1400 HIV-1 infected adults. The two phase III studies — GEMINI-1 and GEMINI-2 — evaluated the two-drug regimen in treatment naïve who have not received prior antiviral therapy, HIV-1 infected adults compared to a three-drug regimen of dolutegravir plus tenofovir alafenamide fumarate and emtricitabine.
The studies demonstrated that the dolutegravir and lamivudine regimen was non-inferior to the standard three-drug regimen in HIV control. This means a two-drug HIV regimen can control HIV in treatment-naïve patients as effectively as a three-drug regimen.
The company expects to file a new drug application (NDA) for this single-tablet regimen in October, using a priority review voucher.
We remind that Glaxo’s HIV portfolio includes Juluca, which is the first two-drug regimen that reduces the number of medicines HIV patients take without compromising on the efficacy of a conventional three-drug regimen. Juluca is developed and marketed by Glaxo in partnership with Johnson and Johnson (JNJ - Free Report) . Juluca received the FDA approval in November last year.
Last month, ViiV Healthcare and partner Johnson and Johnson announced positive headline results from phase III ATLAS study, evaluating another two-drug HIV regimen (2DR). The ATLAS study results showed that the combination of long-acting Edurant (rilpivirine) marketed by Johnson and Johnson and cabotegravir being developed by ViiV Healthcare injected once a month had similar efficacy to a standard of care, daily, oral three-drug regimen at Week 48. The study met its primary endpoint of non-inferiority.
GlaxoSmithKline plc Price
GlaxoSmithKline plc Price | GlaxoSmithKline plc Quote
Zacks Rank & Stock to Consider
Glaxo is a Zacks Rank #3 (Hold) stock.
A better-ranked stock in the same space is Eli Lilly and Company (LLY - Free Report) carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Lilly’s earnings per share estimates have increased from $5.16 to $5.47 for 2018 and from $5.56 to $5.73 for 2019 over the past 60 days. The company delivered a positive earnings surprise in all of the trailing four quarters with an average beat of 10.15%. The stock has rallied 25.3% year to date.
Best Electric Car Stock? You'll Never Guess It.
Zacks Research has released a report that may shock many investors. One stock stands out as the best way to invest in the surge to electric cars. And it's not the one you may think!
Much like petroleum 150 years ago, lithium battery power is set to shake the world, creating millionaires and reshaping geo-politics. Soon electric vehicles (EVs) may be cheaper than gas guzzlers. Some are already reaching 265 miles on a single charge. With battery prices plummeting and charging stations set to multiply, revenues that were already at $31 billion in 2016 are expected to blast to over $67 billion by the end of 2022.
See Zacks Best EV Stock Free >>