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Regeneron Initiates Study on Antibody Cocktail for Coronavirus
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Regeneron Pharmaceuticals, Inc. (REGN - Free Report) has initiated the first study on its experimental dual antibody cocktail, REGN-COV2, for the prevention and treatment of COVID-19.
This program consists of four separate study populations — hospitalized COVID-19 patients, non-hospitalized symptomatic COVID-19 patients, uninfected patients in groups that are at high risk of exposure (such as healthcare workers or first responders) and uninfected patients with close exposure to a COVID-19 patient (such as the patient's housemate). The placebo-controlled studies will be conducted at multiple sites.
The first two adaptive phase I/II/III studies are evaluating REGN-COV2 (REGN10933+REGN10987) as a treatment for hospitalized and non-hospitalized patients with COVID-19. The phase I portion will focus on virologic and safety endpoints while the phase II portion will focus on virologic and clinical endpoints. Data from the phase I and phase II studies will be used to refine the endpoints and determine size for the phase III studies.
The antibody cocktail approach may also have long-term utility for elderly and immuno-compromised patients, who often do not respond well to vaccines.
We note that the Biomedical Advanced Research and Development Authority (BARDA) partly funded REGN-COV2's preclinical development and preclinical/clinical manufacturing.
A positive outcome will significantly boost the growth prospects of the company. Regeneron’s share price has surged 64.9% in the year so far compared with 4.4% growth for the industry.
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, quite a few biotechs are developing antibodies or evaluating their approved drugs or pipeline candidates to determine if they are effective in treating the infected patients.
Regeneron has had a great year so far, soaring high and pioneering the race for a possible coronavirus treatment along with other biotechs like Gilead Sciences, Inc. (GILD - Free Report) .
Gilead’s remdesivir is leading the race for a possible treatment of this deadly virus. The company recently reported mixed results from a late-stage study on investigational antiviral remdesivir in hospitalized patients with moderate COVID-19 pneumonia. It was recently granted regulatory approval in Japan under the brand name, Veklury, as a treatment for SARS-CoV-2 infection. The approval came under an exceptional approval pathway.
Roche too has initiated a late-stage study on its arthritis drug, Actemra/RoActemra, in combination with remdesivir, in hospitalized patients with severe COVID-19 pneumonia.
Alexion is evaluating its rare disease drug, Ultomiris (ravulizumab-cwvz), for the COVID-19 infection. 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 SoC in patients 12 years and above with COVID-19-associated cytokine storm.
Be among the early investors in the new type of device that experts say could impact society as much as the discovery of electricity. Current technology will soon be outdated and replaced by these new devices. In the process, it’s expected to create 22 million jobs and generate $12.3 trillion in activity.
A select few stocks could skyrocket the most as rollout accelerates for this new tech. Early investors could see gains similar to buying Microsoft in the 1990s. Zacks’ just-released special report reveals 8 stocks to watch. The report is only available for a limited time.
Image: Bigstock
Regeneron Initiates Study on Antibody Cocktail for Coronavirus
Regeneron Pharmaceuticals, Inc. (REGN - Free Report) has initiated the first study on its experimental dual antibody cocktail, REGN-COV2, for the prevention and treatment of COVID-19.
This program consists of four separate study populations — hospitalized COVID-19 patients, non-hospitalized symptomatic COVID-19 patients, uninfected patients in groups that are at high risk of exposure (such as healthcare workers or first responders) and uninfected patients with close exposure to a COVID-19 patient (such as the patient's housemate). The placebo-controlled studies will be conducted at multiple sites.
The first two adaptive phase I/II/III studies are evaluating REGN-COV2 (REGN10933+REGN10987) as a treatment for hospitalized and non-hospitalized patients with COVID-19. The phase I portion will focus on virologic and safety endpoints while the phase II portion will focus on virologic and clinical endpoints. Data from the phase I and phase II studies will be used to refine the endpoints and determine size for the phase III studies.
The antibody cocktail approach may also have long-term utility for elderly and immuno-compromised patients, who often do not respond well to vaccines.
We note that the Biomedical Advanced Research and Development Authority (BARDA) partly funded REGN-COV2's preclinical development and preclinical/clinical manufacturing.
A positive outcome will significantly boost the growth prospects of the company. Regeneron’s share price has surged 64.9% in the year so far compared with 4.4% growth for the industry.
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, quite a few biotechs are developing antibodies or evaluating their approved drugs or pipeline candidates to determine if they are effective in treating the infected patients.
Regeneron has had a great year so far, soaring high and pioneering the race for a possible coronavirus treatment along with other biotechs like Gilead Sciences, Inc. (GILD - Free Report) .
Gilead’s remdesivir is leading the race for a possible treatment of this deadly virus. The company recently reported mixed results from a late-stage study on investigational antiviral remdesivir in hospitalized patients with moderate COVID-19 pneumonia. It was recently granted regulatory approval in Japan under the brand name, Veklury, as a treatment for SARS-CoV-2 infection. The approval came under an exceptional approval pathway.
Roche too has initiated a late-stage study on its arthritis drug, Actemra/RoActemra, in combination with remdesivir, in hospitalized patients with severe COVID-19 pneumonia.
Alexion is evaluating its rare disease drug, Ultomiris (ravulizumab-cwvz), for the COVID-19 infection. 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 SoC in patients 12 years and above with COVID-19-associated cytokine storm.
Regeneron currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Biggest Tech Breakthrough in a Generation
Be among the early investors in the new type of device that experts say could impact society as much as the discovery of electricity. Current technology will soon be outdated and replaced by these new devices. In the process, it’s expected to create 22 million jobs and generate $12.3 trillion in activity.
A select few stocks could skyrocket the most as rollout accelerates for this new tech. Early investors could see gains similar to buying Microsoft in the 1990s. Zacks’ just-released special report reveals 8 stocks to watch. The report is only available for a limited time.
See 8 breakthrough stocks now>>