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Gilead (GILD) Files BLA for Bulevirtide for Hepatitis Delta Virus
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Gilead Sciences, Inc. (GILD - Free Report) 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%.
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 - Free Report) 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 - Free Report) 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.
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.
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Gilead (GILD) Files BLA for Bulevirtide for Hepatitis Delta Virus
Gilead Sciences, Inc. (GILD - Free Report) 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%.
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 - Free Report) 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 - Free Report) 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 - Free Report) 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.