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Lilly's (LLY) Coronavirus Treatment Gets Interim Nod in Canada
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Eli Lilly and Company (LLY - Free Report) announced that Health Canada has granted interim authorization to its antibody drug bamlanivimab (LY-CoV555) for the treatment of patients with mild-to-moderate COVID-19. The drug is authorized to treat adults and pediatric patients aged 12 years and above weighing at least 40 kg and who stand at high risk of progressing to severe COVID-19 or hospitalization.
Per the press release, the authorization in Canada came under an interim order respecting the importation, sale and advertising of drugs for addressing the COVID-19 disease.
Earlier this month, the FDA granted an emergency use authorization (EUA) to bamlanivimab as a monotherapy for the treatment of recently-diagnosed patients with mild-to-moderate COVID-19 illness at a high risk of progressing to severe COVID-19 or hospitalization based on data from the phase II BLAZE-1 study. The interim authorization in Canada was also based on the same study. Data from the same showed that treatment with bamlanivimab reduced viral load and rates of symptoms and hospitalization with mild-to-moderate COVID-19.
Shares of Lilly have rallied 9.1% so far this year against the industry’s decrease of 0.2%.
Meanwhile, the BLAZE-1 study is also evaluating bamlanivimab in combination with Lilly’s another COVID-19 antibody candidate etesevimab (LY-CoV016) in patients who were recently diagnosed with COVID-19 in the ambulatory (non-hospitalized) setting. Another study, BLAZE-2, which is 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.
We remind investors that, last week, the FDA also granted an EUA to Lilly and Incyte’s (INCY - Free Report) rheumatoid arthritis drug Olumiant (baricitinib) in combination with Gilead’s (GILD - Free Report) Veklury (remdesivir) for treating hospitalized patients with COVID-19 infection. The EUA was granted based on data from the phase III ACTT-2 study.
In a separate press release, Lilly announced that it entered into a research collaboration and an exclusive license agreement with North Carolina-based biotech Precision BioSciences, Inc. (DTIL - Free Report) for using the latter’s proprietary genome editing platform to develop potential in vivo therapies for treating genetic disorders, especially Duchenne muscular dystrophy (DMD) and two other undisclosed gene targets.
Per the deal, Lilly will make an upfront cash payment of $100 million to Precision and also make an equity investment of $35 million in the latter’s common stock. Precision will also be entitled to receive up to $420 million as milestone fees as well as tiered royalties if a drug is successfully developed and commercialized from the above collaboration.
Precisely, Precision will take responsibility of the pre-clinical research and investigational new drug (IND)-enabling activities while Lilly will lead the clinical development and commercialization. Also, Lilly will have the option to select up to three additional gene targets for this collaboration.
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.
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Lilly's (LLY) Coronavirus Treatment Gets Interim Nod in Canada
Eli Lilly and Company (LLY - Free Report) announced that Health Canada has granted interim authorization to its antibody drug bamlanivimab (LY-CoV555) for the treatment of patients with mild-to-moderate COVID-19. The drug is authorized to treat adults and pediatric patients aged 12 years and above weighing at least 40 kg and who stand at high risk of progressing to severe COVID-19 or hospitalization.
Per the press release, the authorization in Canada came under an interim order respecting the importation, sale and advertising of drugs for addressing the COVID-19 disease.
Earlier this month, the FDA granted an emergency use authorization (EUA) to bamlanivimab as a monotherapy for the treatment of recently-diagnosed patients with mild-to-moderate COVID-19 illness at a high risk of progressing to severe COVID-19 or hospitalization based on data from the phase II BLAZE-1 study. The interim authorization in Canada was also based on the same study. Data from the same showed that treatment with bamlanivimab reduced viral load and rates of symptoms and hospitalization with mild-to-moderate COVID-19.
Shares of Lilly have rallied 9.1% so far this year against the industry’s decrease of 0.2%.
Meanwhile, the BLAZE-1 study is also evaluating bamlanivimab in combination with Lilly’s another COVID-19 antibody candidate etesevimab (LY-CoV016) in patients who were recently diagnosed with COVID-19 in the ambulatory (non-hospitalized) setting. Another study, BLAZE-2, which is 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.
We remind investors that, last week, the FDA also granted an EUA to Lilly and Incyte’s (INCY - Free Report) rheumatoid arthritis drug Olumiant (baricitinib) in combination with Gilead’s (GILD - Free Report) Veklury (remdesivir) for treating hospitalized patients with COVID-19 infection. The EUA was granted based on data from the phase III ACTT-2 study.
In a separate press release, Lilly announced that it entered into a research collaboration and an exclusive license agreement with North Carolina-based biotech Precision BioSciences, Inc. (DTIL - Free Report) for using the latter’s proprietary genome editing platform to develop potential in vivo therapies for treating genetic disorders, especially Duchenne muscular dystrophy (DMD) and two other undisclosed gene targets.
Per the deal, Lilly will make an upfront cash payment of $100 million to Precision and also make an equity investment of $35 million in the latter’s common stock. Precision will also be entitled to receive up to $420 million as milestone fees as well as tiered royalties if a drug is successfully developed and commercialized from the above collaboration.
Precisely, Precision will take responsibility of the pre-clinical research and investigational new drug (IND)-enabling activities while Lilly will lead the clinical development and commercialization. Also, Lilly will have the option to select up to three additional gene targets for this collaboration.
Zacks Rank
Lilly currently carries a Zacks Rank #3 (Hold). 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>>