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Alexion to Evaluate Rare Disease Drug for COVID-19, Shares Up
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Shares of Alexion Pharmaceuticals, Inc. increased 3.13% after it announced that it will initiate a study to evaluate its rare disease drug, Ultomiris (ravulizumab-cwvz), for the COVID-19 infection.
The initiation follows the FDA’s rapid review and acceptance of Alexion’s investigational new drug (IND) application for Ultomiris for severe COVID-19.
The global phase III study will evaluate Ultomiris in a subset of adults with COVID-19 — those who are hospitalized with severe pneumonia or acute respiratory distress syndrome (ARDS).
The study will begin in May and enroll approximately 270 patients across countries with high numbers of diagnosed cases. The study will evaluate the impact of Ultomiris, a biologic medicine, on the survival, the duration of mechanical ventilation and the hospital stay compared to best supportive care. The primary endpoint is survival at day 29. Secondary endpoints will assess the need for mechanical ventilation, oxygenation, duration of ICU stay and hospitalization, and safety, among others.
Alexion decided to initiate the trial after published preclinical data suggested that inhibition of terminal complement can lower cytokine and chemokine levels and significantly reduce lung inflammation and pathology in animal models of viral pneumonia. Additionally, elevated complement biomarkers and promising preliminary clinical evidence from patients who have accessed Alexion’s lead drug Soliris (eculizumab) through its compassionate use program suggested that complement inhibition may improve coronaviral-mediated lung injury.
Ultomiris is approved in the United States and the European Union as a treatment for adults with paroxysmal nocturnal hemoglobinuria (PNH) and in the United States for the atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA) in adult and pediatric (one month of age and older) patients.
Thus, Alexion becomes the latest entrant in the bandwagon of companies repurposing their existing drugs for the treatment of coronavirus.
Alexion’s shares have lost 1.3% in the year so far against the industry’s growth of 3.3%.
Currently, there are no FDA-approved treatments for the severe illness caused by SARS-CoV-2. The pharma/biotech sector is running a race against time to come up with treatments and vaccines to cure the contagion. Given the alarming levels of spread and severity, some approved drugs are being tested to see if they are effective in treating infected patients.
Earlier, Incyte (INCY - Free Report) initiated RUXCOVID, a global, randomized, double-blind, placebo-controlled phase III study evaluating the efficacy and safety of Jakafi plus standard-of-care (SoC) in patients aged 12 and above with COVID-19-associated cytokine storm. The study is sponsored by Incyte in the United States and Novartis (NVS - Free Report) outside of the country. Regeneron (REGN - Free Report) and partner Sanofi are also evaluating their rheumatoid arthritis (RA) drug, Kevzara, to treat patients hospitalized with severe infection due to COVID-19. Roche too is evaluating Actemra for the same.
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Alexion to Evaluate Rare Disease Drug for COVID-19, Shares Up
Shares of Alexion Pharmaceuticals, Inc. increased 3.13% after it announced that it will initiate a study to evaluate its rare disease drug, Ultomiris (ravulizumab-cwvz), for the COVID-19 infection.
The initiation follows the FDA’s rapid review and acceptance of Alexion’s investigational new drug (IND) application for Ultomiris for severe COVID-19.
The global phase III study will evaluate Ultomiris in a subset of adults with COVID-19 — those who are hospitalized with severe pneumonia or acute respiratory distress syndrome (ARDS).
The study will begin in May and enroll approximately 270 patients across countries with high numbers of diagnosed cases. The study will evaluate the impact of Ultomiris, a biologic medicine, on the survival, the duration of mechanical ventilation and the hospital stay compared to best supportive care. The primary endpoint is survival at day 29. Secondary endpoints will assess the need for mechanical ventilation, oxygenation, duration of ICU stay and hospitalization, and safety, among others.
Alexion decided to initiate the trial after published preclinical data suggested that inhibition of terminal complement can lower cytokine and chemokine levels and significantly reduce lung inflammation and pathology in animal models of viral pneumonia. Additionally, elevated complement biomarkers and promising preliminary clinical evidence from patients who have accessed Alexion’s lead drug Soliris (eculizumab) through its compassionate use program suggested that complement inhibition may improve coronaviral-mediated lung injury.
Ultomiris is approved in the United States and the European Union as a treatment for adults with paroxysmal nocturnal hemoglobinuria (PNH) and in the United States for the atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA) in adult and pediatric (one month of age and older) patients.
Thus, Alexion becomes the latest entrant in the bandwagon of companies repurposing their existing drugs for the treatment of coronavirus.
Alexion’s shares have lost 1.3% in the year so far against the industry’s growth of 3.3%.
Currently, there are no FDA-approved treatments for the severe illness caused by SARS-CoV-2. The pharma/biotech sector is running a race against time to come up with treatments and vaccines to cure the contagion. Given the alarming levels of spread and severity, some approved drugs are being tested to see if they are effective in treating infected patients.
Earlier, Incyte (INCY - Free Report) initiated RUXCOVID, a global, randomized, double-blind, placebo-controlled phase III study evaluating the efficacy and safety of Jakafi plus standard-of-care (SoC) in patients aged 12 and above with COVID-19-associated cytokine storm. The study is sponsored by Incyte in the United States and Novartis (NVS - Free Report) outside of the country. Regeneron (REGN - Free Report) and partner Sanofi are also evaluating their rheumatoid arthritis (RA) drug, Kevzara, to treat patients hospitalized with severe infection due to COVID-19. Roche too is evaluating Actemra for the same.
Alexion 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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This outperformance has not just been a recent phenomenon. From 2000 – 2019, while the S&P averaged +6.0% per year, our top strategies averaged up to +54.7% per year.
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