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.
GlaxoSmithKline's Long-Acting HIV Regimen Gets CRL From FDA
Read MoreHide Full Article
GlaxoSmithKline plc’s (GSK - Free Report) HIV subsidiary, ViiV Healthcare, and partner J&J (JNJ - Free Report) received a complete response letter (CRL) from the FDA for its investigational long-acting injectable regimen of cabotegravir and J&J’s Edurant (rilpivirine) for the treatment of HIV-1 infection in virologically suppressed adults.
Glaxo said the CRL was related to to chemistry, manufacturing and controls (CMC) and there were no reported safety issues related to CMC.
ViiV Healthcare had filed the NDA for the long-acting regimen in April which was granted priority review by the FDA in July.
ViiV Healthcare is an HIV company, majorly owned by Glaxo and Pfizer (PFE - Free Report) .
So far this year, Glaxo’s shares have rallied 23.8% compared with the industry’s 11.9% growth.
HIV is a key therapeutic area for Glaxo, with successful dolutegravir-based regimens — Tivicay, Triumeq and Juluca — in its portfolio. In April, ViiV Healthcare obtained FDA approval for a single-tablet, two-drug regimen Dovato for the treatment of naïve HIV-1 adults.
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). Other than the long-acting, injectable, two-drug regimen of cabotegravir and rilpivirine, Glaxo has fostemsavir in its HIV pipeline, developed to treat heavily pretreated HIV patients. An NDA for fostemsavir was filed in December.
Other key players in the HIV market are Gilead (GILD - Free Report) , Merck, AbbVie and J&J.
Just Released: Zacks’ 7 Best Stocks for Today Experts extracted 7 stocks from the list of 220 Zacks Rank #1 Strong Buys that has beaten the market more than 2X over with a stunning average gain of +24.6% per year. These 7 were selected because of their superior potential for immediate breakout.
Image: Bigstock
GlaxoSmithKline's Long-Acting HIV Regimen Gets CRL From FDA
GlaxoSmithKline plc’s (GSK - Free Report) HIV subsidiary, ViiV Healthcare, and partner J&J (JNJ - Free Report) received a complete response letter (CRL) from the FDA for its investigational long-acting injectable regimen of cabotegravir and J&J’s Edurant (rilpivirine) for the treatment of HIV-1 infection in virologically suppressed adults.
Glaxo said the CRL was related to to chemistry, manufacturing and controls (CMC) and there were no reported safety issues related to CMC.
ViiV Healthcare had filed the NDA for the long-acting regimen in April which was granted priority review by the FDA in July.
ViiV Healthcare is an HIV company, majorly owned by Glaxo and Pfizer (PFE - Free Report) .
So far this year, Glaxo’s shares have rallied 23.8% compared with the industry’s 11.9% growth.
HIV is a key therapeutic area for Glaxo, with successful dolutegravir-based regimens — Tivicay, Triumeq and Juluca — in its portfolio. In April, ViiV Healthcare obtained FDA approval for a single-tablet, two-drug regimen Dovato for the treatment of naïve HIV-1 adults.
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). Other than the long-acting, injectable, two-drug regimen of cabotegravir and rilpivirine, Glaxo has fostemsavir in its HIV pipeline, developed to treat heavily pretreated HIV patients. An NDA for fostemsavir was filed in December.
Other key players in the HIV market are Gilead (GILD - Free Report) , Merck, AbbVie and J&J.
Glaxo currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
GlaxoSmithKline plc Price
GlaxoSmithKline plc price | GlaxoSmithKline plc Quote
Just Released: Zacks’ 7 Best Stocks for Today Experts extracted 7 stocks from the list of 220 Zacks Rank #1 Strong Buys that has beaten the market more than 2X over with a stunning average gain of +24.6% per year. These 7 were selected because of their superior potential for immediate breakout.
See these time-sensitive tickers now >>