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Gilead (GILD) Gets FDA Nod for Label Expansion of Epclusa
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Gilead Sciences, Inc. (GILD - Free Report) announced that the FDA has approved a label expansion of its hepatitis C virus (HCV) drug, Epclusa.
The drug has now been approved for treating children as young as 3 years of age, regardless of HCV genotype or liver disease severity. The FDA approved a New Drug Application (NDA) for two strengths of an oral pellet formulation of Epclusa (sofosbuvir 200 mg/velpatasvir 50 mg and sofosbuvir 150 mg/velpatasvir 37.5 mg) developed for use by younger children who cannot swallow tablets. The recommended dosage of Epclusa in children aged 3 years and older is based on weight.
The new oral pellet formulation enables treatment in early childhood with pangenotypic, panfibrotic regimen.
The approval was based on data from a phase II, open-label clinical study that enrolled 41 children, aged 3 years to less than 6 years, to be treated with Epclusa for 12 weeks. At 12 weeks after treatment completion, Epclusa achieved a sustained virologic response (SVR12) or cure rate of 83% (34/41) among all patients, 88% (28/32) in children with HCV genotype 1, 50% (3/6) in children with HCV genotype 2, and 100% in children with HCV genotype 3 (2/2) and HCV genotype 4 (1/1) each. Of the seven patients who did not achieve a cure, all discontinued treatment within one to 20 days of starting treatment.
Gilead’s stock has gained 18.1% this year compared with the industry's gain of 1.9%.
Image Source: Zacks Investment Research
The company’s first-quarter results were disappointing as the HIV business was adversely impacted by the ongoing pandemic. Competition is stiff as well from the likes of GlaxoSmithKline (GSK - Free Report) .
The COVID-19 pandemic is expected to adversely impact HCV treatment initiations and HIV new starts and switches. Gilead expects a more gradual recovery in COVID-related dynamics, starting the second quarter of 2021.
The company is looking to diversify its revenue base as the virology business faces challenges. Gilead recently expanded its collaboration with Novo Nordisk (NVO - Free Report) in non-alcoholic steatohepatitis (“NASH”) with plans to launch a new phase IIb study for a triple combination regimen in NASH patients with cirrhosis.
Gilead currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the health care sector includes Repligen Corp. (RGEN - Free Report) , which carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Repligen’s earnings estimates for 2021 have increased to $2.21 from $1.91 in the past 90 days.
+1,500% Growth: One of 2021’s Most Exciting Investment Opportunities
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Zacks has released a special report to help you capitalize on the Internet of Things’s exponential growth. It reveals 4 under-the-radar stocks that could be some of the most profitable holdings in your portfolio in 2021 and beyond.
Image: Bigstock
Gilead (GILD) Gets FDA Nod for Label Expansion of Epclusa
Gilead Sciences, Inc. (GILD - Free Report) announced that the FDA has approved a label expansion of its hepatitis C virus (HCV) drug, Epclusa.
The drug has now been approved for treating children as young as 3 years of age, regardless of HCV genotype or liver disease severity. The FDA approved a New Drug Application (NDA) for two strengths of an oral pellet formulation of Epclusa (sofosbuvir 200 mg/velpatasvir 50 mg and sofosbuvir 150 mg/velpatasvir 37.5 mg) developed for use by younger children who cannot swallow tablets. The recommended dosage of Epclusa in children aged 3 years and older is based on weight.
The new oral pellet formulation enables treatment in early childhood with pangenotypic, panfibrotic regimen.
The approval was based on data from a phase II, open-label clinical study that enrolled 41 children, aged 3 years to less than 6 years, to be treated with Epclusa for 12 weeks. At 12 weeks after treatment completion, Epclusa achieved a sustained virologic response (SVR12) or cure rate of 83% (34/41) among all patients, 88% (28/32) in children with HCV genotype 1, 50% (3/6) in children with HCV genotype 2, and 100% in children with HCV genotype 3 (2/2) and HCV genotype 4 (1/1) each. Of the seven patients who did not achieve a cure, all discontinued treatment within one to 20 days of starting treatment.
Gilead’s stock has gained 18.1% this year compared with the industry's gain of 1.9%.
The company’s first-quarter results were disappointing as the HIV business was adversely impacted by the ongoing pandemic. Competition is stiff as well from the likes of GlaxoSmithKline (GSK - Free Report) .
The COVID-19 pandemic is expected to adversely impact HCV treatment initiations and HIV new starts and switches. Gilead expects a more gradual recovery in COVID-related dynamics, starting the second quarter of 2021.
The company is looking to diversify its revenue base as the virology business faces challenges. Gilead recently expanded its collaboration with Novo Nordisk (NVO - Free Report) in non-alcoholic steatohepatitis (“NASH”) with plans to launch a new phase IIb study for a triple combination regimen in NASH patients with cirrhosis.
Gilead currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the health care sector includes Repligen Corp. (RGEN - Free Report) , which carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Repligen’s earnings estimates for 2021 have increased to $2.21 from $1.91 in the past 90 days.
+1,500% Growth: One of 2021’s Most Exciting Investment Opportunities
In addition to the stocks you read about above, would you like to see Zacks’ top picks to capitalize on the Internet of Things (IoT)? It is one of the fastest-growing technologies in history, with an estimated 77 billion devices to be connected by 2025. That works out to 127 new devices per second.
Zacks has released a special report to help you capitalize on the Internet of Things’s exponential growth. It reveals 4 under-the-radar stocks that could be some of the most profitable holdings in your portfolio in 2021 and beyond.
Click here to download this report FREE >>