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Gilead's (GILD) Veklury Gets Positive CHMP View for Extended Use
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Gilead Sciences (GILD - Free Report) announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency adopted a positive opinion for the use of Veklury (remdesivir) in COVID-19 patients with severe renal impairment, including those on dialysis.
The European Commission is yet to review the CHMP recommendation. However, subject to approval, Veklury can become the first and only authorized antiviral COVID-19 treatment that can be used across all stages of renal disease.
In Europe, approximately 75 million people suffer from chronic kidney disease (CKD). Patients with advanced CKD or end-stage kidney disease represent a population that is highly vulnerable to COVID-19. Per the company, these patients are at increased risk of morbidity and mortality from COVID-19, with mortality rates as high as 21-25%.
Safe and effective treatment options for these patients are also limited at present. Gilead believes that it can address this unmet clinical need with Veklury, upon approval.
In the past year, shares of Gilead have climbed 19.9% against the industry’s 8.2% fall.
Image Source: Zacks Investment Research
The benefit experienced by hospitalized patients with COVID-19, treated with Veklury, can be observed in randomized controlled trials, real-world evidence and meta-analyses. However, the use of the drug was previously restricted among patients with severe renal impairment due to insufficiency of available data.
The positive opinion adopted by the CHMP for use in people with severe renal impairment, was based on results from Gilead’s phase I pharmacokinetic study as well as the phase III REDPINE study. These studies evaluated the safety of Veklury in patients hospitalized for Covid-19 with severe renal impairment. No additional safety concerns were observed in either of the studies.
In the United States, Veklury is indicated for the treatment of COVID-19 in adults and pediatric patients (≥28 days old and weighing ≥3 kg). These patients are either hospitalized or non-hospitalized having mild-to-moderate Covid-19 and at high risk for progression to severe Covid-19.
In the European Economic Area, Veklury is the only antiviral indicated for both the treatment of COVID-19 in adult and adolescent patients who do not require supplemental oxygen and are at increased risk of developing severe Covid-19, as well as adults, adolescent and pediatric patients with pneumonia requiring supplemental oxygen.
Gilead is also working on an oral direct-acting nucleoside inhibitor, obeldesivir, for the treatment of COVID-19. Currently, there is a significant dearth of new and effective oral treatment options for people with Covid-19. Post metabolization, obeldesivir has the same mechanism of action as Veklury to stop SARS-CoV-2 virus replication.
In the past 90 days, the Zacks Consensus Estimate for Allogene Therapeutics’ 2023 loss per share has narrowed from $2.83 to $2.31. In the past year, shares of Allogene Therapeutics have fallen by 31.6%.
ALLO beat estimates in three of the trailing four quarters, missing the mark on one occasion, delivering an average earnings surprise of 5.08%.
In the past 90 days, the Zacks Consensus Estimate for Akero Therapeutics’ 2023 loss per share has narrowed from $3.46 to $2.78. In the past year, shares of Akero Therapeutics have rallied by 395.6%.
AKRO beat estimates in three of the trailing four quarters, missing the mark on one occasion, delivering an average earnings surprise of 7.96%.
In the past 90 days, the Zacks Consensus Estimate for ADMA Biologics’ 2023 loss per share has narrowed from 19 cents to 9 cents. In the past year, shares of ADMA Biologics have gained by 93.2%.
ADMA beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 19.13%.
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Gilead's (GILD) Veklury Gets Positive CHMP View for Extended Use
Gilead Sciences (GILD - Free Report) announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency adopted a positive opinion for the use of Veklury (remdesivir) in COVID-19 patients with severe renal impairment, including those on dialysis.
The European Commission is yet to review the CHMP recommendation. However, subject to approval, Veklury can become the first and only authorized antiviral COVID-19 treatment that can be used across all stages of renal disease.
In Europe, approximately 75 million people suffer from chronic kidney disease (CKD). Patients with advanced CKD or end-stage kidney disease represent a population that is highly vulnerable to COVID-19. Per the company, these patients are at increased risk of morbidity and mortality from COVID-19, with mortality rates as high as 21-25%.
Safe and effective treatment options for these patients are also limited at present. Gilead believes that it can address this unmet clinical need with Veklury, upon approval.
In the past year, shares of Gilead have climbed 19.9% against the industry’s 8.2% fall.
Image Source: Zacks Investment Research
The benefit experienced by hospitalized patients with COVID-19, treated with Veklury, can be observed in randomized controlled trials, real-world evidence and meta-analyses. However, the use of the drug was previously restricted among patients with severe renal impairment due to insufficiency of available data.
The positive opinion adopted by the CHMP for use in people with severe renal impairment, was based on results from Gilead’s phase I pharmacokinetic study as well as the phase III REDPINE study. These studies evaluated the safety of Veklury in patients hospitalized for Covid-19 with severe renal impairment. No additional safety concerns were observed in either of the studies.
In the United States, Veklury is indicated for the treatment of COVID-19 in adults and pediatric patients (≥28 days old and weighing ≥3 kg). These patients are either hospitalized or non-hospitalized having mild-to-moderate Covid-19 and at high risk for progression to severe Covid-19.
In the European Economic Area, Veklury is the only antiviral indicated for both the treatment of COVID-19 in adult and adolescent patients who do not require supplemental oxygen and are at increased risk of developing severe Covid-19, as well as adults, adolescent and pediatric patients with pneumonia requiring supplemental oxygen.
Gilead is also working on an oral direct-acting nucleoside inhibitor, obeldesivir, for the treatment of COVID-19. Currently, there is a significant dearth of new and effective oral treatment options for people with Covid-19. Post metabolization, obeldesivir has the same mechanism of action as Veklury to stop SARS-CoV-2 virus replication.
Gilead Sciences, Inc. Price and Consensus
Gilead Sciences, Inc. price-consensus-chart | Gilead Sciences, Inc. Quote
Zacks Rank and Stocks to Consider
Gilead currently has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Allogene Therapeutics (ALLO - Free Report) , Akero Therapeutics (AKRO - Free Report) and ADMA Biologics, Inc. (ADMA - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 90 days, the Zacks Consensus Estimate for Allogene Therapeutics’ 2023 loss per share has narrowed from $2.83 to $2.31. In the past year, shares of Allogene Therapeutics have fallen by 31.6%.
ALLO beat estimates in three of the trailing four quarters, missing the mark on one occasion, delivering an average earnings surprise of 5.08%.
In the past 90 days, the Zacks Consensus Estimate for Akero Therapeutics’ 2023 loss per share has narrowed from $3.46 to $2.78. In the past year, shares of Akero Therapeutics have rallied by 395.6%.
AKRO beat estimates in three of the trailing four quarters, missing the mark on one occasion, delivering an average earnings surprise of 7.96%.
In the past 90 days, the Zacks Consensus Estimate for ADMA Biologics’ 2023 loss per share has narrowed from 19 cents to 9 cents. In the past year, shares of ADMA Biologics have gained by 93.2%.
ADMA beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 19.13%.