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Lilly (LLY)/UnitedHealth Launch COVID-19 Study on Bamlanivimab
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Eli Lilly & Company (LLY - Free Report) announced a partnership with UnitedHealth Group’s (UNH - Free Report) research and innovation center, Optum Labs to conduct a pragmatic study to evaluate its COVID-19 antibody drug, bamlanivimab (LY-CoV555)in high-risk, COVID-19 infected individuals.
Bamlanivimab (700 mg injection) was granted Emergency Use Authorization (EUA) by the FDA last month as a monotherapy for the treatment of recently diagnosed mild-to-moderate COVID-19 illness at high risk of progressing to severe COVID-19 or hospitalization.
The study will evaluate the efficacy and safety of bamlanivimab versus a propensity-matched control in people who meet the EUA criteria. The large pragmatic study to be conducted across a diverse population of high-risk individuals for COVID-19 will give further understanding of such antibody drugs in a real-world setting. The study will detect and treat high-risk symptomatic patients who test positive for COVID-19 and includes in-home testing and in-home infusions. This will help identify, intercept and treat COVID-19 early. The study will enroll up to 500,000 people. At least 5,000 of them are expected to be administered bamlanivimab therapy.
Lilly’s shares were up 3% on Friday in response to the news. So far this year, Lilly’s stock has risen 13% compared with an increase of 2.9% for the industry
The EUA for bamlanivimab was based on data from the phase II BLAZE-1 study. The study also evaluated bamlanivimab in combination with Lilly’s another COVID-19 antibody candidate etesevimab (LY-CoV016) in patients recently diagnosed with COVID-19 in the ambulatory (non-hospitalized) setting. Another study, BLAZE-2, a phase III study of bamlanivimab for the prevention (prophylaxis) of COVID-19 in residents and staff at long-term care facilities is also ongoing.
Meanwhile, a NIH-led ACTIV-2 study is testing bamlanivimab in recently diagnosed mild-to-moderate COVID-19 patients.
In November, the FDA also granted EUA to Lilly and Incyte’s (INCY - Free Report) oral JAK inhibitor Olumiant for use in combination with Gilead’s (GILD - Free Report) remdesivir in hospitalized COVID-19 patients based on positive phase III results from the ACTT-2 study.
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Lilly (LLY)/UnitedHealth Launch COVID-19 Study on Bamlanivimab
Eli Lilly & Company (LLY - Free Report) announced a partnership with UnitedHealth Group’s (UNH - Free Report) research and innovation center, Optum Labs to conduct a pragmatic study to evaluate its COVID-19 antibody drug, bamlanivimab (LY-CoV555)in high-risk, COVID-19 infected individuals.
Bamlanivimab (700 mg injection) was granted Emergency Use Authorization (EUA) by the FDA last month as a monotherapy for the treatment of recently diagnosed mild-to-moderate COVID-19 illness at high risk of progressing to severe COVID-19 or hospitalization.
The study will evaluate the efficacy and safety of bamlanivimab versus a propensity-matched control in people who meet the EUA criteria. The large pragmatic study to be conducted across a diverse population of high-risk individuals for COVID-19 will give further understanding of such antibody drugs in a real-world setting. The study will detect and treat high-risk symptomatic patients who test positive for COVID-19 and includes in-home testing and in-home infusions. This will help identify, intercept and treat COVID-19 early. The study will enroll up to 500,000 people. At least 5,000 of them are expected to be administered bamlanivimab therapy.
Lilly’s shares were up 3% on Friday in response to the news. So far this year, Lilly’s stock has risen 13% compared with an increase of 2.9% for the industry
The EUA for bamlanivimab was based on data from the phase II BLAZE-1 study. The study also evaluated bamlanivimab in combination with Lilly’s another COVID-19 antibody candidate etesevimab (LY-CoV016) in patients recently diagnosed with COVID-19 in the ambulatory (non-hospitalized) setting. Another study, BLAZE-2, a phase III study of bamlanivimab for the prevention (prophylaxis) of COVID-19 in residents and staff at long-term care facilities is also ongoing.
Meanwhile, a NIH-led ACTIV-2 study is testing bamlanivimab in recently diagnosed mild-to-moderate COVID-19 patients.
In November, the FDA also granted EUA to Lilly and Incyte’s (INCY - Free Report) oral JAK inhibitor Olumiant for use in combination with Gilead’s (GILD - Free Report) remdesivir in hospitalized COVID-19 patients based on positive phase III results from the ACTT-2 study.
Lilly currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Breakout Biotech Stocks with Triple-Digit Profit Potential
The biotech sector is projected to surge beyond $775 billion by 2024 as scientists develop treatments for thousands of diseases. They’re also finding ways to edit the human genome to literally erase our vulnerability to these diseases.
Zacks has just released Century of Biology: 7 Biotech Stocks to Buy Right Now to help investors profit from 7 stocks poised for outperformance. Our recent biotech recommendations have produced gains of +50%, +83% and +164% in as little as 2 months. The stocks in this report could perform even better.
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