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Glaxo, J&J's Dual Drug HIV Regimen Succeeds in Phase III Study
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GlaxoSmithKline’s (GSK - Free Report) HIV drug subsidiary-ViiV Healthcare and partner Johnson and Johnson (JNJ - Free Report) announced positive headline results from phase III ATLAS study evaluating a two-drug regimen (2DR) for the treatment of HIV.
Shares of the company rose 1.7% following annuncemnet of the news. This year so far, shares of Glaxo have gone up 15.1% compared with the industry’s growth of 2.8%.
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.
The study also showed that overall safety, virologic response and drug resistance results for the injectable 2DR regimen were consistent with earlier phase II LATTE and LATTE-2 study results. The LATTE and LATTE-2 studies assessed cabotegravir plus Edurant, as a two-drug oral antiretroviral regimen, for the maintenance of viral suppression in antiretroviral-naive HIV-1-infected individuals.
The ATLAS study was designed to determine whether HIV-1-infected adults who had maintained viral suppression for at least six months, on a daily oral regimen comprising of two nucleoside reverse transcriptase inhibitors (NRTIs) plus a third agent, maintained similar rates of viral suppression when switched to a long-acting, injectable regimen of cabotegravir and Edurant.
If the 2DR regimen is approved, people living with HIV will get a month between each dose of antiretroviral therapy, changing HIV treatment from 365 dosing days per year, to just 12.
The company will present detailed results at an upcoming scientific meeting. The companies also expect to present topline results from FLAIR, a second study designed to evaluate the investigational long-acting, injectable regimen of Edurant and cabotegravir in people living with HIV, later in 2018.
We remind that Glaxo and J&J’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 received FDA approval, in November last year.
Further, we remind investors that ViiV Healthcare is a HIV company majorly owned by Glaxo and Pfizer (PFE - Free Report) .
Gilead’s earnings per share estimates have increased from $6.12 to $6.57 for 2018 and from $6.36 to $6.48 for 2019 over the past 30 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 6.43%. The stock has rallied 5.6% so far this year.
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It's hard to believe, even for us at Zacks. But while the market gained +21.9% in 2017, our top stock-picking screens have returned +115.0%, +109.3%, +104.9%, +98.6%, and +67.1%.
And this outperformance has not just been a recent phenomenon. Over the years it has been remarkably consistent. From 2000 - 2017, the composite yearly average gain for these strategies has beaten the market more than 19X over. Maybe even more remarkable is the fact that we're willing to share their latest stocks with you without cost or obligation.
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Glaxo, J&J's Dual Drug HIV Regimen Succeeds in Phase III Study
GlaxoSmithKline’s (GSK - Free Report) HIV drug subsidiary-ViiV Healthcare and partner Johnson and Johnson (JNJ - Free Report) announced positive headline results from phase III ATLAS study evaluating a two-drug regimen (2DR) for the treatment of HIV.
Shares of the company rose 1.7% following annuncemnet of the news. This year so far, shares of Glaxo have gone up 15.1% compared with the industry’s growth of 2.8%.
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.
The study also showed that overall safety, virologic response and drug resistance results for the injectable 2DR regimen were consistent with earlier phase II LATTE and LATTE-2 study results. The LATTE and LATTE-2 studies assessed cabotegravir plus Edurant, as a two-drug oral antiretroviral regimen, for the maintenance of viral suppression in antiretroviral-naive HIV-1-infected individuals.
The ATLAS study was designed to determine whether HIV-1-infected adults who had maintained viral suppression for at least six months, on a daily oral regimen comprising of two nucleoside reverse transcriptase inhibitors (NRTIs) plus a third agent, maintained similar rates of viral suppression when switched to a long-acting, injectable regimen of cabotegravir and Edurant.
If the 2DR regimen is approved, people living with HIV will get a month between each dose of antiretroviral therapy, changing HIV treatment from 365 dosing days per year, to just 12.
The company will present detailed results at an upcoming scientific meeting. The companies also expect to present topline results from FLAIR, a second study designed to evaluate the investigational long-acting, injectable regimen of Edurant and cabotegravir in people living with HIV, later in 2018.
We remind that Glaxo and J&J’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 received FDA approval, in November last year.
Further, we remind investors that ViiV Healthcare is a HIV company majorly owned by Glaxo and Pfizer (PFE - Free Report) .
GlaxoSmithKline plc Price
GlaxoSmithKline plc Price | GlaxoSmithKline plc Quote
Zacks Rank & Stocks to Consider
Glaxo carries a Zacks Rank #3 (Hold).
A better-ranked stock from the same space worth considering is Gilead Sciences Inc. (GILD - Free Report) carrying a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Gilead’s earnings per share estimates have increased from $6.12 to $6.57 for 2018 and from $6.36 to $6.48 for 2019 over the past 30 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 6.43%. The stock has rallied 5.6% so far this year.
Today's Stocks from Zacks' Hottest Strategies
It's hard to believe, even for us at Zacks. But while the market gained +21.9% in 2017, our top stock-picking screens have returned +115.0%, +109.3%, +104.9%, +98.6%, and +67.1%.
And this outperformance has not just been a recent phenomenon. Over the years it has been remarkably consistent. From 2000 - 2017, the composite yearly average gain for these strategies has beaten the market more than 19X over. Maybe even more remarkable is the fact that we're willing to share their latest stocks with you without cost or obligation.
See Them Free>>