We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Roche to Evaluate Actemra for Severe COVID-19 Pneumonia
Read MoreHide Full Article
Roche Holdings (RHHBY - Free Report) announced that it is working with the FDA to initiate a late-stage study to evaluate the safety and efficacy of rheumatoid arthritis drug Actemra/RoActemra (tocilizumab) plus standard of care in hospitalized adult patients with severe COVID-19 pneumonia compared to placebo plus standard of care.
The randomized, double-blind, placebo-controlled phase III study will be conducted in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Health and Human Services Office of the Assistant Secretary for Preparedness and Response (ASPR).
Per Roche, this is the first global study of Actemra/RoActemra in this setting. The study is expected to begin enrolling, with a target of approximately 330 patients globally, including the United States.
The primary and secondary endpoints include clinical status, mortality, mechanical ventilation and intensive care unit (ICU) variables. Patients will be followed for 60 days post-randomization, and an interim analysis will be conducted to look for early evidence of efficacy.
Meanwhile, several independent clinical ongoing studies exploring the efficacy and safety of Actemra/RoActemra for the treatment of patients with COVID-19 pneumonia. The drug has been included in the 7th updated diagnosis and treatment plan for COVID-19 issued by China’s National Health Commission (NHC) on Mar 3, 2020.
Apart from RA, Actemra is approved globally for polyarticular juvenile idiopathic arthritis (pJIA) and in the United States and Europe for systemic juvenile idiopathic arthritis (sJIA) in children two years of age and older.
Currently, there are no FDA-approved treatments for the severe illness caused by SARS-CoV-2. Given the alarming levels of spread and severity, some approved drugs or pipeline candidates are being tested to see if they are effective in treating the infected patients.
Earlier, Roche received FDA Emergency Use Authorisation for the cobas SARS-CoV-2 Test to detect the novel virus that causes the COVID-19 disease.
Roche’s stock has gained 10.6% in the past year against the industry’s 9.8% decline.
Quite a few pharma and biotech companies are striving hard to come up with treatments and vaccines to combat this virus.
Regeneron (REGN - Free Report) and partner Sanofi (SNY - Free Report) have also announced a program to evaluate their RA drug, Kevzara, to treat patients hospitalized with severe infection due to COVID-19. Regeneron also has identified antibodies, which can possibly treat COVID-19. Earlier in the week, Moderna, Inc., (MRNA - Free Report) dosed the first participant in the phase I study of mRNA vaccine (mRNA-1273) against the SARS-CoV-2.
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.
Image: Bigstock
Roche to Evaluate Actemra for Severe COVID-19 Pneumonia
Roche Holdings (RHHBY - Free Report) announced that it is working with the FDA to initiate a late-stage study to evaluate the safety and efficacy of rheumatoid arthritis drug Actemra/RoActemra (tocilizumab) plus standard of care in hospitalized adult patients with severe COVID-19 pneumonia compared to placebo plus standard of care.
The randomized, double-blind, placebo-controlled phase III study will be conducted in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Health and Human Services Office of the Assistant Secretary for Preparedness and Response (ASPR).
Per Roche, this is the first global study of Actemra/RoActemra in this setting. The study is expected to begin enrolling, with a target of approximately 330 patients globally, including the United States.
The primary and secondary endpoints include clinical status, mortality, mechanical ventilation and intensive care unit (ICU) variables. Patients will be followed for 60 days post-randomization, and an interim analysis will be conducted to look for early evidence of efficacy.
Meanwhile, several independent clinical ongoing studies exploring the efficacy and safety of Actemra/RoActemra for the treatment of patients with COVID-19 pneumonia. The drug has been included in the 7th updated diagnosis and treatment plan for COVID-19 issued by China’s National Health Commission (NHC) on Mar 3, 2020.
Apart from RA, Actemra is approved globally for polyarticular juvenile idiopathic arthritis (pJIA) and in the United States and Europe for systemic juvenile idiopathic arthritis (sJIA) in children two years of age and older.
Currently, there are no FDA-approved treatments for the severe illness caused by SARS-CoV-2. Given the alarming levels of spread and severity, some approved drugs or pipeline candidates are being tested to see if they are effective in treating the infected patients.
Earlier, Roche received FDA Emergency Use Authorisation for the cobas SARS-CoV-2 Test to detect the novel virus that causes the COVID-19 disease.
Roche’s stock has gained 10.6% in the past year against the industry’s 9.8% decline.
Quite a few pharma and biotech companies are striving hard to come up with treatments and vaccines to combat this virus.
Regeneron (REGN - Free Report) and partner Sanofi (SNY - Free Report) have also announced a program to evaluate their RA drug, Kevzara, to treat patients hospitalized with severe infection due to COVID-19. Regeneron also has identified antibodies, which can possibly treat COVID-19. Earlier in the week, Moderna, Inc., (MRNA - Free Report) dosed the first participant in the phase I study of mRNA vaccine (mRNA-1273) against the SARS-CoV-2.
Roche 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.
See these 7 breakthrough stocks now>>