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.
RedHill Files CTA for Coronavirus Study on Opaganib in Russia
Read MoreHide Full Article
RedHill Biopharma Ltd. (RDHL - Free Report) announced that it has filed a Clinical Trial Application (CTA) to Ministry of Health of the Russian Federation to initiate a phase II/III study on its novel investigational candidate, opaganib. The company is looking to investigate opaganib in patients hospitalized with severe COVID-19 infection and pneumonia.
It plans to conduct the above-mentioned study at clinical centers across Russia alongside additional European and other countries.
Per the company, this multi-center, double-blind, placebo-controlled study is looking to enroll 270 subjects with severe COVID-19 pneumonia who require hospitalization and treatment with supplemental oxygenation. The primary endpoint of the study is to check the proportion of patients requiring intubation and mechanical ventilation by day 14.
Notably, RedHill is also initiating a phase IIa study to evaluate opaganib for addressing severe COVID-19 patients in the United States.
Following the aforementioned news on Wednesday, shares of RedHill were up 6.5%. The stock has rallied 26% so far this year against the industry’s decrease of 4.5%.
We note that in April 2020, RedHill submitted an investigational new drug (IND) application to the FDA for beginning a clinical study on opaganib to treat adults diagnosed with COVID-19 and pneumonia. In May, the regulatory agency approved the said IND application for a phase IIa clinical study evaluating opaganib in patients with confirmed moderate-to-severe COVID-19 infection.
Meanwhile, a compassionate use program for opaganib is already underway in Israel to evaluate patients with confirmed COVID-19 infection. Several patients have been treated to date with preliminary positive outcomes.
In April, RedHill entered into an agreement with the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the National Institutes of Health (NIH). The company will provide NIAID with its investigational candidate RHB-107 (upamostat, WX-671)1 for non-clinical testing to evaluate the candidate’s activity against SARS-CoV-2, the virus that causes coronavirus disease (COVID-19).
The COVID-19 outbreak already infected more than 7.2 million people and the death toll crossed 412,583 globally.
Currently, there are no FDA-approved treatments for the severe illness caused by SARS-CoV-2. Given the alarming levels of its spread and severity, some approved drugs are being tested to check their effectiveness in treating the infection.
Many companies are evaluating their marketed drugs to address the deadly COVID-19contagion. These are Roche’s (RHHBY - Free Report) rheumatoid arthritis (RA) drug Actemra and Regeneron/Sanofi’s (SNY - Free Report) RA drug Kevzara to name a few.
In May, pharma bigwig AstraZeneca (AZN - Free Report) received more than $1 billion in funding from BARDA to develop a coronavirus vaccine, which presently in a phase II/III stage. The study is being conducted in collaboration with Oxford University.
We remain optimistic about the latest updates in the pharma sector as several companies are coordinating with global authorities on rolling out a treatment as early as possible to neutralize this critical virus.
Each was hand-picked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2020. Each comes from a different sector and has unique qualities and catalysts that could fuel exceptional growth.
Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.
Image: Bigstock
RedHill Files CTA for Coronavirus Study on Opaganib in Russia
RedHill Biopharma Ltd. (RDHL - Free Report) announced that it has filed a Clinical Trial Application (CTA) to Ministry of Health of the Russian Federation to initiate a phase II/III study on its novel investigational candidate, opaganib. The company is looking to investigate opaganib in patients hospitalized with severe COVID-19 infection and pneumonia.
It plans to conduct the above-mentioned study at clinical centers across Russia alongside additional European and other countries.
Per the company, this multi-center, double-blind, placebo-controlled study is looking to enroll 270 subjects with severe COVID-19 pneumonia who require hospitalization and treatment with supplemental oxygenation. The primary endpoint of the study is to check the proportion of patients requiring intubation and mechanical ventilation by day 14.
Notably, RedHill is also initiating a phase IIa study to evaluate opaganib for addressing severe COVID-19 patients in the United States.
Following the aforementioned news on Wednesday, shares of RedHill were up 6.5%. The stock has rallied 26% so far this year against the industry’s decrease of 4.5%.
We note that in April 2020, RedHill submitted an investigational new drug (IND) application to the FDA for beginning a clinical study on opaganib to treat adults diagnosed with COVID-19 and pneumonia. In May, the regulatory agency approved the said IND application for a phase IIa clinical study evaluating opaganib in patients with confirmed moderate-to-severe COVID-19 infection.
Meanwhile, a compassionate use program for opaganib is already underway in Israel to evaluate patients with confirmed COVID-19 infection. Several patients have been treated to date with preliminary positive outcomes.
In April, RedHill entered into an agreement with the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the National Institutes of Health (NIH). The company will provide NIAID with its investigational candidate RHB-107 (upamostat, WX-671)1 for non-clinical testing to evaluate the candidate’s activity against SARS-CoV-2, the virus that causes coronavirus disease (COVID-19).
The COVID-19 outbreak already infected more than 7.2 million people and the death toll crossed 412,583 globally.
Currently, there are no FDA-approved treatments for the severe illness caused by SARS-CoV-2. Given the alarming levels of its spread and severity, some approved drugs are being tested to check their effectiveness in treating the infection.
Many companies are evaluating their marketed drugs to address the deadly COVID-19contagion. These are Roche’s (RHHBY - Free Report) rheumatoid arthritis (RA) drug Actemra and Regeneron/Sanofi’s (SNY - Free Report) RA drug Kevzara to name a few.
In May, pharma bigwig AstraZeneca (AZN - Free Report) received more than $1 billion in funding from BARDA to develop a coronavirus vaccine, which presently in a phase II/III stage. The study is being conducted in collaboration with Oxford University.
We remain optimistic about the latest updates in the pharma sector as several companies are coordinating with global authorities on rolling out a treatment as early as possible to neutralize this critical virus.
Zacks Rank
RedHill currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
5 Stocks Set to Double
Each was hand-picked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2020. Each comes from a different sector and has unique qualities and catalysts that could fuel exceptional growth.
Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.
Today, See These 5 Potential Home Runs >>