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Gilead Reports Promising Data on Experimental Coronavirus Drug
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Gilead Sciences, Inc. (GILD - Free Report) announced promising results on experimental antiviral, remdesivir, in patients hospitalized with severe complications of COVID-19.
Remdesivir is an investigational nucleotide analog with broad-spectrum antiviral activity in both vitro and vivo in animal models against multiple emerging viral pathogens, including Ebola, Marburg, MERS and SARS.
Gilead has been providing emergency access to remdesivir for qualifying patients with severe complications of COVID-19 who are unable to enroll in ongoing clinical trials.
This cohort evaluated data from 53 patients in the United States, Europe, Canada and Japan, who received at least one dose of remdesivir on or before Mar 7, 2020, through Gilead’s compassionate use program. All patients were hospitalized with severe acute respiratory coronavirus 2 (SARS-CoV-2) infection, with either an oxygen saturation of 94% or less or a need for oxygen.
Results from this cohort showed that the majority of patients in this international cohort demonstrated clinical improvement and no new safety signals were identified with the remdesivir treatment.
Approximately 64% of patients in this cohort were on mechanical ventilation at baseline, including four also on extracorporeal membrane oxygenation (ECMO). Results showed that treatment with remdesivir resulted in an improvement in oxygen support class for 68% of patients over a median follow-up of 18 days from the first dose of remdesivir. More than half of patients on mechanical ventilation were extubated and nearly half of all patients (47%) were discharged from the hospital following treatment with remdesivir. The cumulative incidence of clinical improvement, defined as discharge from the hospital and/or at least a two-point improvement from baseline on a predefined six-point scale, was 84% after 28 days of follow up, according to the Kaplan-Meier analysis.
However, clinical improvement was less frequent among patients on invasive ventilation versus noninvasive ventilation and patients at least 70 years of age. The overall mortality rate in this cohort was 13%. The mortality rate was higher in the subgroup of patients who were on invasive ventilation (18%) as compared to patients on noninvasive oxygen support (5%). Factors associated with an increased risk of mortality included age greater than 70 years and higher baseline serum creatinine levels, indicating reduced kidney function. Mild–to-moderate liver enzyme (ALT and/or AST) elevations were observed in this cohort. No new safety signals were detected during short-term remdesivir therapy.
Multiple phase III studies are ongoing to determine the safety and efficacy of the candidate for the treatment of COVID-19 as data from ongoing, randomized clinical studies are needed to provide a scientifically robust understanding of the clinical impact of the treatment.
Currently, Gilead is conducting two phase III studies on remdesivir — the SIMPLE studies — in countries with a higher prevalence of COVID-19. Data from the SIMPLE study in patients with severe disease are expected later this month, while data from the SIMPLE study in patients with moderate disease are expected next month.
Additionally, the company is supporting multiple clinical trials led by other organizations, including two studies conducted in Hubei Province, China. However, the study in China in patients with severe disease was terminated early due to low enrollment and the company awaits the publication of these data to enable an in-depth review of the results. The study in China in patients with mild-to-moderate disease is ongoing. A global study of remdesivir led by NIAID continues to enroll patients and data from this study are anticipated next month.
Gilead’s shares have gained 13.1% this year so far against the industry’s decline of 6.6%.
Currently, there are no FDA-approved treatments for the severe illness caused by SARS-CoV-2. Given the alarming levels of spread and severity, some approved drugs or pipeline candidates are being tested to see if these are effective in treating the infected patients.
As remdesivir has shown promising results in infected patients, investors are banking on Gilead for being the first company to come up with a treatment for this deadly disease.
While the company is pioneering the race for developing a potential cure for COVID-19, other companies have joined the bandwagon as well.
Regeneron Pharmaceuticals (REGN - Free Report) too has identified antibodies, which can possibly treat coronavirus. Regeneron and partner Sanofi (SNY - Free Report) are also evaluating their rheumatoid arthritis (RA) drug, Kevzara, to treat patients hospitalized with severe infection due to COVID-19. Johnson & Johnson (JNJ - Free Report) recently announced the selection of a lead coronavirus vaccine candidate.
Experts extracted 7 stocks from the list of 220 Zacks Rank #1 Strong Buys that has beaten the market more than 2X over with a stunning average gain of +24.5% per year.
These 7 were selected because of their superior potential for immediate breakout.
Image: Bigstock
Gilead Reports Promising Data on Experimental Coronavirus Drug
Gilead Sciences, Inc. (GILD - Free Report) announced promising results on experimental antiviral, remdesivir, in patients hospitalized with severe complications of COVID-19.
Remdesivir is an investigational nucleotide analog with broad-spectrum antiviral activity in both vitro and vivo in animal models against multiple emerging viral pathogens, including Ebola, Marburg, MERS and SARS.
Gilead has been providing emergency access to remdesivir for qualifying patients with severe complications of COVID-19 who are unable to enroll in ongoing clinical trials.
This cohort evaluated data from 53 patients in the United States, Europe, Canada and Japan, who received at least one dose of remdesivir on or before Mar 7, 2020, through Gilead’s compassionate use program. All patients were hospitalized with severe acute respiratory coronavirus 2 (SARS-CoV-2) infection, with either an oxygen saturation of 94% or less or a need for oxygen.
Results from this cohort showed that the majority of patients in this international cohort demonstrated clinical improvement and no new safety signals were identified with the remdesivir treatment.
Approximately 64% of patients in this cohort were on mechanical ventilation at baseline, including four also on extracorporeal membrane oxygenation (ECMO). Results showed that treatment with remdesivir resulted in an improvement in oxygen support class for 68% of patients over a median follow-up of 18 days from the first dose of remdesivir. More than half of patients on mechanical ventilation were extubated and nearly half of all patients (47%) were discharged from the hospital following treatment with remdesivir. The cumulative incidence of clinical improvement, defined as discharge from the hospital and/or at least a two-point improvement from baseline on a predefined six-point scale, was 84% after 28 days of follow up, according to the Kaplan-Meier analysis.
However, clinical improvement was less frequent among patients on invasive ventilation versus noninvasive ventilation and patients at least 70 years of age.
The overall mortality rate in this cohort was 13%. The mortality rate was higher in the subgroup of patients who were on invasive ventilation (18%) as compared to patients on noninvasive oxygen support (5%). Factors associated with an increased risk of mortality included age greater than 70 years and higher baseline serum creatinine levels, indicating reduced kidney function. Mild–to-moderate liver enzyme (ALT and/or AST) elevations were observed in this cohort. No new safety signals were detected during short-term remdesivir therapy.
Multiple phase III studies are ongoing to determine the safety and efficacy of the candidate for the treatment of COVID-19 as data from ongoing, randomized clinical studies are needed to provide a scientifically robust understanding of the clinical impact of the treatment.
Currently, Gilead is conducting two phase III studies on remdesivir — the SIMPLE studies — in countries with a higher prevalence of COVID-19. Data from the SIMPLE study in patients with severe disease are expected later this month, while data from the SIMPLE study in patients with moderate disease are expected next month.
Additionally, the company is supporting multiple clinical trials led by other organizations, including two studies conducted in Hubei Province, China. However, the study in China in patients with severe disease was terminated early due to low enrollment and the company awaits the publication of these data to enable an in-depth review of the results. The study in China in patients with mild-to-moderate disease is ongoing. A global study of remdesivir led by NIAID continues to enroll patients and data from this study are anticipated next month.
Gilead’s shares have gained 13.1% this year so far against the industry’s decline of 6.6%.
Currently, there are no FDA-approved treatments for the severe illness caused by SARS-CoV-2. Given the alarming levels of spread and severity, some approved drugs or pipeline candidates are being tested to see if these are effective in treating the infected patients.
As remdesivir has shown promising results in infected patients, investors are banking on Gilead for being the first company to come up with a treatment for this deadly disease.
While the company is pioneering the race for developing a potential cure for COVID-19, other companies have joined the bandwagon as well.
Regeneron Pharmaceuticals (REGN - Free Report) too has identified antibodies, which can possibly treat coronavirus. Regeneron and partner Sanofi (SNY - Free Report) are also evaluating their rheumatoid arthritis (RA) drug, Kevzara, to treat patients hospitalized with severe infection due to COVID-19. Johnson & Johnson (JNJ - Free Report) recently announced the selection of a lead coronavirus vaccine candidate.
Gilead currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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