We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Glaxo's (GSK) Rukobia Gets CHMP Nod for Heavily Pre-Treated HIV
Read MoreHide Full Article
GlaxoSmithKline plc’s (GSK - Free Report) HIV subsidiary, ViiV Healthcare, announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency has rendered a positive opinion recommending approval for Rukobia (fostemsavir) to treat heavily treatment-experienced adult patients with HIV-1 infection.
The company is seeking approval of its first-in-class attachment inhibitor, Rukobia (600 mg, extended-release tablets), for use in combination with other antiretroviral agents to treat adult patients with multidrug resistant HIV-1 infection, for whom it is otherwise not possible to form a suppressive anti-viral regimen.
The CHMP opinion was based on data from the pivotal phase III BRIGHTE study which evaluated the safety and efficacy of Rukobia in combination with an optimised background therapy (“OBT”) in the given patient population.
Data from the study showed that 60% of heavily treatment-experienced adult patients who received Rukobia with an OBT achieved and maintained viral suppression at 96 weeks of treatment.
ViiV Healthcare filed a marketing authorization application in January 2020. A final decision from the European Commission is expected in the coming months.
Notably, in July 2020, the FDA approved Rukobia for treating heavily treatment-experienced adult patients with HIV-1 infection.
Shares of Glaxo have plunged 20% so far this year against the industry’s increase of 4.2%.
ViiV Healthcare is an HIV company, majorly owned by Glaxo and Pfizer (PFE - Free Report) .
Notably, ViiV Healthcare focuses on advancing HIV care by exploring new treatment paradigms (two-drug regimens), modalities (long-acting injectables) and mechanisms of actions (including maturation inhibitors and broadly neutralizing antibodies).
We remind investors that HIV is a key therapeutic area for Glaxo. However, rising competitive pressure coupled with shift within its portfolio toward two-drug regimens is hurting sales of Glaxo’s HIV business. HIV sales totaled £3.6 billion in the first nine months of 2020, reflecting an increase of only 1% year-over-year. Upon potential approval, new medicines should further boost sales of the HIV franchise.
Last year, it generated $24 billion in global revenues. By 2020, it's predicted to blast through the roof to $77.6 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for regular investors who make the right trades early.
Image: Bigstock
Glaxo's (GSK) Rukobia Gets CHMP Nod for Heavily Pre-Treated HIV
GlaxoSmithKline plc’s (GSK - Free Report) HIV subsidiary, ViiV Healthcare, announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency has rendered a positive opinion recommending approval for Rukobia (fostemsavir) to treat heavily treatment-experienced adult patients with HIV-1 infection.
The company is seeking approval of its first-in-class attachment inhibitor, Rukobia (600 mg, extended-release tablets), for use in combination with other antiretroviral agents to treat adult patients with multidrug resistant HIV-1 infection, for whom it is otherwise not possible to form a suppressive anti-viral regimen.
The CHMP opinion was based on data from the pivotal phase III BRIGHTE study which evaluated the safety and efficacy of Rukobia in combination with an optimised background therapy (“OBT”) in the given patient population.
Data from the study showed that 60% of heavily treatment-experienced adult patients who received Rukobia with an OBT achieved and maintained viral suppression at 96 weeks of treatment.
ViiV Healthcare filed a marketing authorization application in January 2020. A final decision from the European Commission is expected in the coming months.
Notably, in July 2020, the FDA approved Rukobia for treating heavily treatment-experienced adult patients with HIV-1 infection.
Shares of Glaxo have plunged 20% so far this year against the industry’s increase of 4.2%.
ViiV Healthcare is an HIV company, majorly owned by Glaxo and Pfizer (PFE - Free Report) .
Notably, ViiV Healthcare focuses on advancing HIV care by exploring new treatment paradigms (two-drug regimens), modalities (long-acting injectables) and mechanisms of actions (including maturation inhibitors and broadly neutralizing antibodies).
We remind investors that HIV is a key therapeutic area for Glaxo. However, rising competitive pressure coupled with shift within its portfolio toward two-drug regimens is hurting sales of Glaxo’s HIV business. HIV sales totaled £3.6 billion in the first nine months of 2020, reflecting an increase of only 1% year-over-year. Upon potential approval, new medicines should further boost sales of the HIV franchise.
Other key players in the HIV market are Gilead Sciences (GILD - Free Report) , Merck (MRK - Free Report) and AbbVie (ABBV - Free Report) .
Zacks Rank
Glaxo currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
The Hottest Tech Mega-Trend of All
Last year, it generated $24 billion in global revenues. By 2020, it's predicted to blast through the roof to $77.6 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for regular investors who make the right trades early.
See Zacks' 3 Best Stocks to Play This Trend >>