Advertisement
Canada markets close in 3 hours 11 minutes

  • S&P/TSX

    21,845.44
    -28.28 (-0.13%)
     

  • S&P 500

    5,029.10
    -42.53 (-0.84%)
     

  • DOW

    37,981.14
    -479.78 (-1.25%)
     

  • CAD/USD

    0.7310
    +0.0012 (+0.17%)
     

  • CRUDE OIL

    82.56
    -0.25 (-0.30%)
     

  • Bitcoin CAD

    87,901.70
    -609.94 (-0.69%)
     

  • CMC Crypto 200

    1,386.10
    +3.53 (+0.26%)
     

  • GOLD FUTURES

    2,339.60
    +1.20 (+0.05%)
     

  • RUSSELL 2000

    1,971.54
    -23.89 (-1.20%)
     

  • 10-Yr Bond

    4.7020
    +0.0500 (+1.07%)
     

  • NASDAQ

    15,523.60
    -189.15 (-1.20%)
     

  • VOLATILITY

    16.51
    +0.54 (+3.38%)
     

  • FTSE

    8,078.86
    +38.48 (+0.48%)
     

  • NIKKEI 225

    37,628.48
    -831.60 (-2.16%)
     

  • CAD/EUR

    0.6809
    -0.0010 (-0.15%)
     
MARKETS LIVE BLOG:

STOCKS SLIDE AFTER META'S REALITY CHECK, WITH GDP ON DECK

Owner of Facebook and Instagram plans to spend up to US$10B on AI infrastructure investments

Gilead's EU Regulatory Application for HIV Drug Validated

Zacks Equity Research
Updated

HIV is one of the primary areas of focus for Gilead Sciences Inc. GILD. The company has submitted a marketing application for yet another tenofovir alafenamide (TAF)-based regimen for the treatment of HIV.

Gilead’s regulatory application for a once-daily single tablet regimen combining Gilead’s Emtriva (emtricitabine) and TAF along with Johnson & Johnson’s JNJ Edurant (rilpivirine) has been fully validated and is now under regulatory review in the EU.

Last year, Gilead and Johnson & Johnson had expanded their agreement for the development and commercialization of the TAF, Emtriva and Edurant combination. If approved, Gilead will undertake the responsibility of manufacturing, registration, distribution and commercialization of the cocktail therapy in most countries, while Johnson & Johnson will distribute it in approximately 17 markets.

Other TAF-based Regimens at Gilead

We remind investors that this is the third TAF-based regulatory application that is under review by the European Medicines Agency (EMA).

Earlier, the company had submitted a marketing authorization application (MAA) for a TAF-based single tablet regimen comprising TAF, Vitekta (elvitegravir), Tybost (cobicistat) and Emtriva, for the treatment of adults suffering from HIV-1 infection.

Gilead had filed another MAA for two doses of a fixed-dose combination of Emtriva and TAF for HIV-1 infection in combination with other HIV antiretroviral drugs.

The company is also looking to get all the three TAF-based combinations approved in the U.S. and has submitted regulatory applications for the same.

Gilead’s pipeline includes a fourth TAF-based regimen comprising TAF, Emtriva, Tybost and Johnson & Johnson’s Prezista (darunavir).

Our Take

We are pleased with the pipeline progress at Gilead. If approved, we believe that the TAF-based regimens would complement the company’s current portfolio. Gilead’s portfolio includes several drugs targeting HIV among which Tybost and Vitekta were approved last year.

Gilead carries a Zacks Rank #1 (Strong Buy). A couple of other favorably ranked stocks in the health care sector are Valeant Pharmaceuticals International, Inc. VRX and Infinity Pharmaceuticals, Inc. INFI. While Valeant carries a Zacks Rank #1 (Strong Buy), Infinity Pharma holds a Zacks Rank #2 (Buy).

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days.Click to get this free report >>


Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
 
GILEAD SCIENCES (GILD): Free Stock Analysis Report
 
VALEANT PHARMA (VRX): Free Stock Analysis Report
 
JOHNSON & JOHNS (JNJ): Free Stock Analysis Report
 
INFINITY PHARMA (INFI): Free Stock Analysis Report
 
To read this article on Zacks.com click here.
 
Zacks Investment Research