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Gilead (GILD) MAA for HIV Inhibitor Under the EMA's Review
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Gilead Sciences, Inc. (GILD - Free Report) recently announced that its Marketing Authorization Application (MAA) for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor, has been fully validated. The MAA is now under evaluation with the European Medicines Agency (“EMA”).
The application is seeking approval of the candidate for the treatment of HIV-1 infection, in combination with other antiretroviral(s), in adults with multidrug resistant HIV-1 infection who are currently on a failing antiretroviral treatment regimen due to resistance, intolerance or safety considerations.
The application will be reviewed by the EMA’s Committee for Medicinal Products for Human Use (CHMP) under the centralized licensing procedure.
The MAA is supported by encouraging data from the ongoing CAPELLA study. The study achieved its primary endpoint by showing that a significantly higher proportion of participants randomly allocated to receive oral lenacapavir in combination with an optimized background regimen (n=24) achieved a clinically meaningful viral load reduction of at least 0.5 log10 copies/mL from baseline compared with those randomly allocated to receive placebo (n=12) during the 14-day functional monotherapy period. The candidate was generally well-tolerated.
While most antivirals act on just one stage of viral replication, lenacapavir is designed to inhibit HIV-1 at multiple stages of its lifecycle.
Gilead has also submitted a New Drug Application (NDA) for lenacapavir seeking FDA approval for the treatment of HIV-1 infection in heavily treatment-experienced people with multi-drug resistant HIV-1 infection in combination with other antiretrovirals.
The agency had granted Breakthrough Therapy Designation to the candidate for the same.
Gilead’s stock has gained 23.5% this year against the industry's decline of 2.6%.
Image Source: Zacks Investment Research
Gilead’s second-quarter results were better than expected. HIIV therapy, Biktarvy, registered continued growth and gains in market share despite the ongoing impact of the pandemic. However, the loss of exclusivity of Truvada and Atripla has affected the HIV franchise’s performance. Competition is stiff as well from the likes of GlaxoSmithKline (GSK - Free Report) .
Gilead has also collaborated with a subsidiary of Merck & Co., Inc., (MRK - Free Report) to develop and commercialize long-acting, investigational treatment combinations of Gilead’s lenacapavir and Merck’s islatravir in HIV.
Image: Shutterstock
Gilead (GILD) MAA for HIV Inhibitor Under the EMA's Review
Gilead Sciences, Inc. (GILD - Free Report) recently announced that its Marketing Authorization Application (MAA) for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor, has been fully validated. The MAA is now under evaluation with the European Medicines Agency (“EMA”).
The application is seeking approval of the candidate for the treatment of HIV-1 infection, in combination with other antiretroviral(s), in adults with multidrug resistant HIV-1 infection who are currently on a failing antiretroviral treatment regimen due to resistance, intolerance or safety considerations.
The application will be reviewed by the EMA’s Committee for Medicinal Products for Human Use (CHMP) under the centralized licensing procedure.
The MAA is supported by encouraging data from the ongoing CAPELLA study. The study achieved its primary endpoint by showing that a significantly higher proportion of participants randomly allocated to receive oral lenacapavir in combination with an optimized background regimen (n=24) achieved a clinically meaningful viral load reduction of at least 0.5 log10 copies/mL from baseline compared with those randomly allocated to receive placebo (n=12) during the 14-day functional monotherapy period. The candidate was generally well-tolerated.
While most antivirals act on just one stage of viral replication, lenacapavir is designed to inhibit HIV-1 at multiple stages of its lifecycle.
Gilead has also submitted a New Drug Application (NDA) for lenacapavir seeking FDA approval for the treatment of HIV-1 infection in heavily treatment-experienced people with multi-drug resistant HIV-1 infection in combination with other antiretrovirals.
The agency had granted Breakthrough Therapy Designation to the candidate for the same.
Gilead’s stock has gained 23.5% this year against the industry's decline of 2.6%.
Image Source: Zacks Investment Research
Gilead’s second-quarter results were better than expected. HIIV therapy, Biktarvy, registered continued growth and gains in market share despite the ongoing impact of the pandemic. However, the loss of exclusivity of Truvada and Atripla has affected the HIV franchise’s performance. Competition is stiff as well from the likes of GlaxoSmithKline (GSK - Free Report) .
Gilead has also collaborated with a subsidiary of Merck & Co., Inc., (MRK - Free Report) to develop and commercialize long-acting, investigational treatment combinations of Gilead’s lenacapavir and Merck’s islatravir in HIV.
Gilead currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the same space is Repligen Corporation (RGEN - Free Report) , which currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Earnings estimates for Repligen for 2021 are up 50 cents in the past 30 days. The stock is up 35.5% in the year so far.