RedHill Biopharma Ltd. (RDHL - Free Report) announced that the FDA has cleared the investigational new drug (IND) application to begin a phase II/III study on its second coronavirus candidate RHB-107 for addressing patients with symptomatic COVID-19 who do not require hospitalization. Enrollment in the study is expected to begin early next year.
The double-blind phase II/III study will enroll patients with symptomatic diagnostically confirmed COVID-19 infection who do not require hospitalization. The primary endpoints will include the safety and tolerability of RHB-107 and also check the time to recovery from symptomatic illness versus placebo.
Notably, RHB-107, an orally administered serine protease inhibitor, demonstrated a strong inhibition of SARS-CoV-2 viral replication in a human bronchial cell model. RHB-107 is also being evaluated in several mid-stage studies for treating cancer, inflammatory lung diseases and gastrointestinal diseases.
Shares of RedHill have surged 32.4% so far this year against the industry’s decrease of 3.2%.
In April 2020, RedHill entered into an agreement with the National Institute of Allergy and Infectious Diseases (NIAID), to evaluate RHB-107 and check its activity against SARS-CoV-2, the virus that causes coronavirus disease.
We note that RHB-107 is RedHill’s second investigational drug that is being evaluated for COVID-19. The company is also evaluating its novel investigational candidate, opaganib as a potential treatment for COVID-19.
Earlier this week, RedHill completed enrollment in the phase II study investigating opaganib in patients hospitalized with severe COVID-19 pneumonia in the United States. Top-line data from the study are expected in the coming weeks.
Meanwhile, a global phase II/III study on opaganib (administered orally) for severe COVID-19 already enrolled more than 50% of the total cohort and is on track to enroll all 270 patients. Top-line data is expected in the first quarter of 2021. Per the company, data from the phase II study in the United States and the global phase II/III study will support the potential emergency use authorization application for opaganib.
We note that the pharma/biotech sector is racing against time to develop treatments and vaccines for curing the COVID-19 contagion.
Earlier this month, the FDA granted Emergency Use Authorization (EUA) to Eli Lilly’s (LLY - Free Report) antibody drug bamlanivimab (LY-CoV555) as a monotherapy for treating the recently-diagnosed mild-to-moderate COVID-19 illness in patients who are at high risk of progressing to severe COVID-19 or hospitalization.
Last month, Regeneron (REGN - Free Report) submitted a request to the FDA for an Emergency Use Authorization (EUA) for its experimental COVID-19 treatment REGN-COV2 in patients with mild-to-moderate COVID-19 who are at risk of poor outcomes. Meanwhile, Vir Biotechnology (VIR - Free Report) is evaluating its investigational monoclonal antibody VIR-7831 in a phase III study for the early treatment of COVID-19 in patients who are at high risk of hospitalization.
Zacks Rank
RedHill currently carries a Zacks Rank #4 (Sell).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Zacks Names “Single Best Pick to Double”
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You know this company from its past glory days, but few would expect that it’s poised for a monster turnaround. Fresh from a successful repositioning and flush with A-list celeb endorsements, it could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in a little more than 9 months and Nvidia which boomed +175.9% in one year.
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Zacks Names "Single Best Pick to Double"
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
It’s a little-known chemical company that’s up 65% over last year, yet still dirt cheap. With unrelenting demand, soaring 2022 earnings estimates, and $1.5 billion for repurchasing shares, retail investors could jump in at any time.
This company could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in little more than 9 months and NVIDIA which boomed +175.9% in one year.
Free: See Our Top Stock and 4 Runners Up >>
RedHill Biopharma Ltd. (RDHL - Free Report) announced that the FDA has cleared the investigational new drug (IND) application to begin a phase II/III study on its second coronavirus candidate RHB-107 for addressing patients with symptomatic COVID-19 who do not require hospitalization. Enrollment in the study is expected to begin early next year.
The double-blind phase II/III study will enroll patients with symptomatic diagnostically confirmed COVID-19 infection who do not require hospitalization. The primary endpoints will include the safety and tolerability of RHB-107 and also check the time to recovery from symptomatic illness versus placebo.
Notably, RHB-107, an orally administered serine protease inhibitor, demonstrated a strong inhibition of SARS-CoV-2 viral replication in a human bronchial cell model. RHB-107 is also being evaluated in several mid-stage studies for treating cancer, inflammatory lung diseases and gastrointestinal diseases.
Shares of RedHill have surged 32.4% so far this year against the industry’s decrease of 3.2%.
In April 2020, RedHill entered into an agreement with the National Institute of Allergy and Infectious Diseases (NIAID), to evaluate RHB-107 and check its activity against SARS-CoV-2, the virus that causes coronavirus disease.
We note that RHB-107 is RedHill’s second investigational drug that is being evaluated for COVID-19. The company is also evaluating its novel investigational candidate, opaganib as a potential treatment for COVID-19.
Earlier this week, RedHill completed enrollment in the phase II study investigating opaganib in patients hospitalized with severe COVID-19 pneumonia in the United States. Top-line data from the study are expected in the coming weeks.
Meanwhile, a global phase II/III study on opaganib (administered orally) for severe COVID-19 already enrolled more than 50% of the total cohort and is on track to enroll all 270 patients. Top-line data is expected in the first quarter of 2021. Per the company, data from the phase II study in the United States and the global phase II/III study will support the potential emergency use authorization application for opaganib.
We note that the pharma/biotech sector is racing against time to develop treatments and vaccines for curing the COVID-19 contagion.
Earlier this month, the FDA granted Emergency Use Authorization (EUA) to Eli Lilly’s (LLY - Free Report) antibody drug bamlanivimab (LY-CoV555) as a monotherapy for treating the recently-diagnosed mild-to-moderate COVID-19 illness in patients who are at high risk of progressing to severe COVID-19 or hospitalization.
Last month, Regeneron (REGN - Free Report) submitted a request to the FDA for an Emergency Use Authorization (EUA) for its experimental COVID-19 treatment REGN-COV2 in patients with mild-to-moderate COVID-19 who are at risk of poor outcomes. Meanwhile, Vir Biotechnology (VIR - Free Report) is evaluating its investigational monoclonal antibody VIR-7831 in a phase III study for the early treatment of COVID-19 in patients who are at high risk of hospitalization.
Zacks Rank
RedHill currently carries a Zacks Rank #4 (Sell).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Zacks Names “Single Best Pick to Double”
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
You know this company from its past glory days, but few would expect that it’s poised for a monster turnaround. Fresh from a successful repositioning and flush with A-list celeb endorsements, it could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in a little more than 9 months and Nvidia which boomed +175.9% in one year.
Free: See Our Top Stock and 4 Runners Up >>
Zacks Names "Single Best Pick to Double"
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
It’s a little-known chemical company that’s up 65% over last year, yet still dirt cheap. With unrelenting demand, soaring 2022 earnings estimates, and $1.5 billion for repurchasing shares, retail investors could jump in at any time.
This company could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in little more than 9 months and NVIDIA which boomed +175.9% in one year.
Free: See Our Top Stock and 4 Runners Up >>
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