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Roche's (RHHBY) Actemra Gets FDA Emergency Nod for COVID-19
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Roche Holding AG (RHHBY - Free Report) announced that the FDA has granted Emergency Use Authorization (“EUA”) to its arthritis drug Actemra/RoActemra (tocilizumab) for the treatment of COVID-19 in hospitalized adults and pediatric patients aged two years and above, who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation or extracorporeal membrane oxygenation.
The EUA was based on data from four studies which evaluated the safety and efficacy of Actemra/RoActemra for the treatment of COVID-19 in hospitalized patients. Data from these studies recommend that Actemra/RoActemra may improve outcomes in patients who are receiving corticosteroids and require supplemental oxygen or breathing support.
Notably, the latest FDA authorization enables emergency use of Actemra/RoActemra for treating COVID-19 in hospitalized adult and pediatric patients.
Shares of Roche have rallied 7.1% so far this year compared with the industry’s growth of 8.2%.
Image Source: Zacks Investment Research
Please note that the RECOVERY Actemra/RoActemra study was conducted by researchers in the United Kingdom, while Roche sponsored the placebo-controlled EMPACTA, COVACTA and REMDACTA studies.
In March 2021, Roche announced data from the REMDACTA study, which evaluated Actemra/RoActemra plus Gilead Sciences’ (GILD - Free Report) Veklury (remdesivir) in patients with severe COVID-19 pneumonia. The study did not meet its primary endpoint of improved time to hospital discharge for patients with severe COVID-19 pneumonia compared to Veklury alone.
Roche continues to evaluate data from the REMDACTA, COVACTA and EMPACTA studies, as well as from other studies of Actemra/RoActemra in COVID-19 pneumonia.
Roche has also collaborated with Regeneron (REGN - Free Report) to increase the global supply of the latter’s antibody cocktail, REGEN-COV, for COVID-19 treatment. Regeneron is responsible for the development and distribution of the treatment in the United States, and Roche is primarily responsible for the development and distribution of the same outside the country.
Notably, other antibody drugs approved for emergency use for treating high-risk COVID-19 patients are Eli Lilly’s (LLY - Free Report) cocktail therapy, bamlanivimab plus etesevimab. In May 2021, the FDA granted an EUA to Vir Biotechnology and GlaxoSmithKline’s dual-action monoclonal antibody, sotrovimab, for high-risk COVID-19.
In a separate press release, Roche announced that the European Commission has approved Enspryng (satralizumab) as the first subcutaneous treatment of adults and adolescents aged 12 years and above, living with an anti-aquaporin-4 antibody (AQP4-IgG) seropositive neuromyelitis optica spectrum disorder (“NMOSD”), as a monotherapy or in combination with immunosuppressive therapy or IST.
Per the company, Enspryng is the first and only NMOSD treatment which is to be administered subcutaneously every four weeks.
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Image: Bigstock
Roche's (RHHBY) Actemra Gets FDA Emergency Nod for COVID-19
Roche Holding AG (RHHBY - Free Report) announced that the FDA has granted Emergency Use Authorization (“EUA”) to its arthritis drug Actemra/RoActemra (tocilizumab) for the treatment of COVID-19 in hospitalized adults and pediatric patients aged two years and above, who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation or extracorporeal membrane oxygenation.
The EUA was based on data from four studies which evaluated the safety and efficacy of Actemra/RoActemra for the treatment of COVID-19 in hospitalized patients. Data from these studies recommend that Actemra/RoActemra may improve outcomes in patients who are receiving corticosteroids and require supplemental oxygen or breathing support.
Notably, the latest FDA authorization enables emergency use of Actemra/RoActemra for treating COVID-19 in hospitalized adult and pediatric patients.
Shares of Roche have rallied 7.1% so far this year compared with the industry’s growth of 8.2%.
Please note that the RECOVERY Actemra/RoActemra study was conducted by researchers in the United Kingdom, while Roche sponsored the placebo-controlled EMPACTA, COVACTA and REMDACTA studies.
In March 2021, Roche announced data from the REMDACTA study, which evaluated Actemra/RoActemra plus Gilead Sciences’ (GILD - Free Report) Veklury (remdesivir) in patients with severe COVID-19 pneumonia. The study did not meet its primary endpoint of improved time to hospital discharge for patients with severe COVID-19 pneumonia compared to Veklury alone.
Roche continues to evaluate data from the REMDACTA, COVACTA and EMPACTA studies, as well as from other studies of Actemra/RoActemra in COVID-19 pneumonia.
Roche has also collaborated with Regeneron (REGN - Free Report) to increase the global supply of the latter’s antibody cocktail, REGEN-COV, for COVID-19 treatment. Regeneron is responsible for the development and distribution of the treatment in the United States, and Roche is primarily responsible for the development and distribution of the same outside the country.
Notably, other antibody drugs approved for emergency use for treating high-risk COVID-19 patients are Eli Lilly’s (LLY - Free Report) cocktail therapy, bamlanivimab plus etesevimab. In May 2021, the FDA granted an EUA to Vir Biotechnology and GlaxoSmithKline’s dual-action monoclonal antibody, sotrovimab, for high-risk COVID-19.
In a separate press release, Roche announced that the European Commission has approved Enspryng (satralizumab) as the first subcutaneous treatment of adults and adolescents aged 12 years and above, living with an anti-aquaporin-4 antibody (AQP4-IgG) seropositive neuromyelitis optica spectrum disorder (“NMOSD”), as a monotherapy or in combination with immunosuppressive therapy or IST.
Per the company, Enspryng is the first and only NMOSD treatment which is to be administered subcutaneously every four weeks.
Zacks Rank
Roche currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Bitcoin, Like the Internet Itself, Could Change Everything
Blockchain and cryptocurrency has sparked one of the most exciting discussion topics of a generation. Some call it the “Internet of Money” and predict it could change the way money works forever. If true, it could do to banks what Netflix did to Blockbuster and Amazon did to Sears. Experts agree we’re still in the early stages of this technology, and as it grows, it will create several investing opportunities.
Zacks’ has just revealed 3 companies that can help investors capitalize on the explosive profit potential of Bitcoin and the other cryptocurrencies with significantly less volatility than buying them directly.
See 3 crypto-related stocks now >>