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.
Gilead Sciences (GILD) Announces Positive HDV Treatment Data
Read MoreHide Full Article
Gilead Sciences, Inc. (GILD - Free Report) announced results from the late-stage MYR301 study evaluating the first-in-class entry inhibitor Hepcludex (bulevirtide) for the treatment of adults with chronic hepatitis delta virus (HDV) infection at week 96.
MYR301 is an ongoing, phase III study evaluating the long-term efficacy and safety of bulevirtide in 150 people living with chronic HDV randomly allocated to treatment with bulevirtide 2 mg once daily (n=49), 10 mg once daily (n=50) or no antiviral treatment (delayed treatment, n=51).
The primary efficacy and safety data were assessed after 48 weeks, post which participants in the delayed treatment group of the study were switched to bulevirtide 10 mg once daily for an additional 96 weeks. The total duration of treatment across all groups in the study is 144 weeks.
The new data presented at week 96 reinforced the efficacy and safety of bulevirtide and demonstrated additional improvements in combined response. These improvements were observed at week 96 compared with week 48, with no signs of treatment resistance.
Further analysis from the MYR301 study showed that study participants who did not respond or only partially responded to bulevirtide treatment at week 24 went on to achieve a virologic response at week 96 with continued bulevirtide monotherapy.
These results highlight that prolonged treatment with bulevirtide led to a virological and/or biochemical response even in patients who initially had a suboptimal virologic response (after 24 weeks of treatment). These data were presented at the 2023 European Association for the Study of the Liver (EASL) Congress.
Please note that bulevirtide was initially granted conditional marketing authorization (MA) in July 2020 for patients living with HDV in the European Union. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended granting full MA to bulevirtide for treating adults with chronic HDV and compensated liver disease in April 2023.
Bulevirtide was granted Breakthrough Therapy and Orphan Drug designations by the FDA in the United States.
HDV is the most severe form of viral hepatitis and affects an estimated 5% of people living with hepatitis B (HBV).
Shares of Gilead have lost 9.4% in the year so far compared with the industry’s 7.6% decline.
Image Source: Zacks Investment Research
Gilead’s first-quarter results were pretty ordinary, as the decline in Veklury sales dragged the top line.
Nevertheless, HIV treatment Biktarvy remains the leading treatment for those seeking to switch to a new regimen in the United States as well as those starting treatments in both the United States and Europe. Earlier, the FDA approved Sunlenca (lenacapavir), in combination with other antiretroviral(s), for the treatment of HIV-1 infection in heavily treatment-experienced adults with multi-drug-resistant HIV-1 infection.
The oncology business also continues to perform well and the label expansion of Trodelvy will further boost the franchise. Currently, the company is also looking to diversify its portfolio.
Some top-ranked stocks in the healthcare sector are Ligand Pharmaceuticals (LGND - Free Report) and Novartis (NVS - Free Report) . LGND currently sports a Zacks Rank #1 and Novartis carries a Zacks Rank #2 (Buy).
Over the past 60 days, earnings estimates for LGND have increased by 86 cents per share to $5.25. LGND topped earnings estimates in two of the last four quarters and missed in the remaining two, the average surprise being 21.50%.
Over the past 60 days, NVS’ earnings estimates have increased to $6.74 from $6.57 for 2023. Novartis surpassed estimates in all the trailing four quarters, the average surprise being 5.15%.
See More Zacks Research for These Tickers
Normally $25 each - click below to receive one report FREE:
Image: Bigstock
Gilead Sciences (GILD) Announces Positive HDV Treatment Data
Gilead Sciences, Inc. (GILD - Free Report) announced results from the late-stage MYR301 study evaluating the first-in-class entry inhibitor Hepcludex (bulevirtide) for the treatment of adults with chronic hepatitis delta virus (HDV) infection at week 96.
MYR301 is an ongoing, phase III study evaluating the long-term efficacy and safety of bulevirtide in 150 people living with chronic HDV randomly allocated to treatment with bulevirtide 2 mg once daily (n=49), 10 mg once daily (n=50) or no antiviral treatment (delayed treatment, n=51).
The primary efficacy and safety data were assessed after 48 weeks, post which participants in the delayed treatment group of the study were switched to bulevirtide 10 mg once daily for an additional 96 weeks. The total duration of treatment across all groups in the study is 144 weeks.
The new data presented at week 96 reinforced the efficacy and safety of bulevirtide and demonstrated additional improvements in combined response. These improvements were observed at week 96 compared with week 48, with no signs of treatment resistance.
Further analysis from the MYR301 study showed that study participants who did not respond or only partially responded to bulevirtide treatment at week 24 went on to achieve a virologic response at week 96 with continued bulevirtide monotherapy.
These results highlight that prolonged treatment with bulevirtide led to a virological and/or biochemical response even in patients who initially had a suboptimal virologic response (after 24 weeks of treatment). These data were presented at the 2023 European Association for the Study of the Liver (EASL) Congress.
Please note that bulevirtide was initially granted conditional marketing authorization (MA) in July 2020 for patients living with HDV in the European Union. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended granting full MA to bulevirtide for treating adults with chronic HDV and compensated liver disease in April 2023.
Bulevirtide was granted Breakthrough Therapy and Orphan Drug designations by the FDA in the United States.
HDV is the most severe form of viral hepatitis and affects an estimated 5% of people living with hepatitis B (HBV).
Shares of Gilead have lost 9.4% in the year so far compared with the industry’s 7.6% decline.
Image Source: Zacks Investment Research
Gilead’s first-quarter results were pretty ordinary, as the decline in Veklury sales dragged the top line.
Nevertheless, HIV treatment Biktarvy remains the leading treatment for those seeking to switch to a new regimen in the United States as well as those starting treatments in both the United States and Europe. Earlier, the FDA approved Sunlenca (lenacapavir), in combination with other antiretroviral(s), for the treatment of HIV-1 infection in heavily treatment-experienced adults with multi-drug-resistant HIV-1 infection.
The oncology business also continues to perform well and the label expansion of Trodelvy will further boost the franchise. Currently, the company is also looking to diversify its portfolio.
Zacks Rank and Stocks to Consider
Gilead currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Some top-ranked stocks in the healthcare sector are Ligand Pharmaceuticals (LGND - Free Report) and Novartis (NVS - Free Report) . LGND currently sports a Zacks Rank #1 and Novartis carries a Zacks Rank #2 (Buy).
Over the past 60 days, earnings estimates for LGND have increased by 86 cents per share to $5.25. LGND topped earnings estimates in two of the last four quarters and missed in the remaining two, the average surprise being 21.50%.
Over the past 60 days, NVS’ earnings estimates have increased to $6.74 from $6.57 for 2023. Novartis surpassed estimates in all the trailing four quarters, the average surprise being 5.15%.