U.S. markets closed
  • S&P Futures

    4,411.00
    +21.00 (+0.48%)
     
  • Dow Futures

    34,288.00
    +131.00 (+0.38%)
     
  • Nasdaq Futures

    14,529.50
    +103.00 (+0.71%)
     
  • Russell 2000 Futures

    1,995.40
    +10.00 (+0.50%)
     
  • Crude Oil

    85.81
    +0.67 (+0.79%)
     
  • Gold

    1,834.00
    +2.20 (+0.12%)
     
  • Silver

    24.32
    0.00 (0.00%)
     
  • EUR/USD

    1.1338
    -0.0017 (-0.15%)
     
  • 10-Yr Bond

    1.7470
    -0.0860 (-4.69%)
     
  • Vix

    28.85
    +3.26 (+12.74%)
     
  • GBP/USD

    1.3550
    +0.0005 (+0.03%)
     
  • USD/JPY

    113.7670
    +0.1120 (+0.10%)
     
  • BTC-USD

    36,050.97
    +880.83 (+2.50%)
     
  • CMC Crypto 200

    870.86
    +628.18 (+258.85%)
     
  • FTSE 100

    7,494.13
    -90.88 (-1.20%)
     
  • Nikkei 225

    27,522.26
    0.00 (0.00%)
     

Gilead (GILD) Files BLA for Bulevirtide for Hepatitis Delta Virus

  • Oops!
    Something went wrong.
    Please try again later.
  • Oops!
    Something went wrong.
    Please try again later.
  • Oops!
    Something went wrong.
    Please try again later.
  • Oops!
    Something went wrong.
    Please try again later.
·3 min read
In this article:
  • Oops!
    Something went wrong.
    Please try again later.
  • Oops!
    Something went wrong.
    Please try again later.
  • Oops!
    Something went wrong.
    Please try again later.
  • Oops!
    Something went wrong.
    Please try again later.
  • GILD
  • MRK
  • GSK
  • DTIL

Gilead Sciences, Inc. GILD announced that it has submitted a biologics license application (“BLA”) to the FDA for its first-in-class antiviral medicine, bulevirtide (2 mg injection), for the treatment of chronic hepatitis delta virus (“HDV”) infection in adult patients with compensated liver disease.

The FDA has already granted Breakthrough Therapy and Orphan Drug designations to bulevirtide for the given indication.

If approved, bulevirtide will become the first treatment for adult patients with chronic HDV infection with compensated liver disease in the United States.

The BLA filing was based on data from completed and ongoing phase II studies as well as the ongoing phase III MYR301 study that supported the safety and efficacy of bulevirtide (2 mg) administered once daily following 24 weeks of treatment.

Per the company, interim data from the phase III MYR301 study showed that the proportion of people with HDV infection achieving the combined virological and biochemical response was 36.7% in treatment with bulevirtide 2 mg, 28% in participants who received bulevirtide 10 mg and 0% in participants who have not received antiviral treatment following 24 weeks of therapy. Treatment with bulevirtide 2 mg led to a statistically significant response versus the no-treatment group after 24 weeks.

Shares of Gilead have increased 17.9% so far this year against the industry’s decrease of 14.3%.

Zacks Investment Research
Zacks Investment Research

Image Source: Zacks Investment Research

We remind investors that the European Commission has granted conditional marketing authorization to bulevirtide for treating adults suffering from chronic HDV infection with compensated liver disease in Europe. The medicine is marketed under the brand name Hepcludex.

In the first nine months of 2021, Hepcludex generated sales worth $25 million while launch activities continued across Europe.

Gilead is a dominant player in the HIV market. Its HIV therapy, Biktarvy, continues to drive growth 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 in the HIV market as well from the likes of GlaxoSmithKline GSK among others.

GlaxoSmithKline reported an 8% growth in its HIV franchise in the third quarter, driven by its new HIV products Dovato, Juluca, Rukobia, and Cabenuva.

To further strengthen its HIV franchise, Gilead has collaborated with a subsidiary of Merck MRK to develop and commercialize long-acting, investigational treatment combinations of Gilead’s lenacapavir and Merck’s islatravir in HIV.

Gilead and Merck have recently initiated a phase II study evaluating an oral weekly combination of lenacapavir and islatravir in people who are living with HIV who are virologically suppressed on an antiretroviral therapy.

Zacks Rank & Stock to Consider

Gilead currently carries a Zacks Rank #3 (Hold). A top-ranked stock in the biotech sector is Precision BioSciences, Inc. DTIL which has a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Precision BioSciences’ loss per share estimates have narrowed 44.4% for 2021 and 20.1% for 2022, over the past 60 days. The stock has rallied 12.1% year to date.

Earnings of Precision BioSciences have surpassed estimates in each of the trailing four quarters.


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

GlaxoSmithKline plc (GSK) : Free Stock Analysis Report

Merck & Co., Inc. (MRK) : Free Stock Analysis Report

Gilead Sciences, Inc. (GILD) : Free Stock Analysis Report

Precision BioSciences, Inc. (DTIL) : Free Stock Analysis Report

To read this article on Zacks.com click here.