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CytoDyn's Leronlimab Progressing Well in Coronavirus Program
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CytoDyn Inc. (CYDY - Free Report) announced that it has treated the first patient with its promising CCR5 antagonist candidate, leronlimab, in a phase IIb/III study evaluating it in severe and critically ill COVID-19 patients. The company plans to rapidly enroll patients in this study.
The study will evaluate two-week administration of leronlimab in the patient population for primary endpoint of mortality rate at 28 days and a secondary endpoint of mortality rate at 14 days. The company plans to conduct an interim analysis on the data from 50 patients.
The company is also evaluating leronlimab in a phase IIb study in mild-to-moderate COVID-19 patients.
Apart from these two clinical studies, CytoDyn has also administered leronlimab in about 30 patients, through hospitals and clinics, under Emergency Investigational New Drug ("EIND") authorizations granted by the FDA.
Data from patients under EIND has been promising. The first five patients with mild-to-moderate infection have been removed from oxygen. The company reported blood samples data last week from severely ill COVID-19 patients receiving leronlimab under EIND. The data demonstrated that patients had encouraging immune restoration as well as dramatic reduction in the critical cytokine storm (excessive or uncontrolled levels of immune response) after seven days of treatment. Patients are also benefiting from leronlimab treatment with them being removed from external ventilation or extubated within seven days.
CytoDyn remains hopeful that similar therapeutic benefits in patients treated in two clinical studies will pave way for an FDA approval for leronlimab as a COVID-19 treatment. It has also collaborated with the United Kingdom’s Department of Health for emergency access to leronlimab for severe and critically ill COVID-19 patients.
We note that, the company’s leronlimab is being developed for multiple cancer indications. In a separate press release, the company announced that the first patient was treated with the candidate in a phase II basket study evaluating it for 22 solid cancer tumors. However, patient enrolment in the study has been delayed due to COVID-19.
CytoDyn’s shares have surged 140% so far this year against the industry’s decline of 15.9%.
Several large pharma companies have joined the race to develop an effective treatment for the deadly coronavirus infection, which has affected more than 2 million people globally with the death toll rising to more than 138,000.
Earlier this week, AstraZeneca (AZN - Free Report) announced plans to begin a global clinical study soon to evaluate its blood cancer drug, Calquence, for treating exaggerated immune response associated with COVID-19 infection in severely ill patients. Lilly (LLY - Free Report) in partnership with the National Institute of Allergy and Infectious Diseases will evaluate its rheumatoid arthritis drug, Olumiant, as a potential treatment for hospitalized patients diagnosed with COVID-19. Other large pharma companies evaluating their marketed drugs as a potential COVID-19 treatment include Sanofi (SNY - Free Report) and Roche.
Gilead is also developing its antiviral candidate, remdesivir, in patients hospitalized with severe complications of COVID-19. Earlier this week, the company announced data from patients receiving treatment with the candidate under compassionate use program, which showed that the majority of patients demonstrated clinical improvement.
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.
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CytoDyn's Leronlimab Progressing Well in Coronavirus Program
CytoDyn Inc. (CYDY - Free Report) announced that it has treated the first patient with its promising CCR5 antagonist candidate, leronlimab, in a phase IIb/III study evaluating it in severe and critically ill COVID-19 patients. The company plans to rapidly enroll patients in this study.
The study will evaluate two-week administration of leronlimab in the patient population for primary endpoint of mortality rate at 28 days and a secondary endpoint of mortality rate at 14 days. The company plans to conduct an interim analysis on the data from 50 patients.
The company is also evaluating leronlimab in a phase IIb study in mild-to-moderate COVID-19 patients.
Apart from these two clinical studies, CytoDyn has also administered leronlimab in about 30 patients, through hospitals and clinics, under Emergency Investigational New Drug ("EIND") authorizations granted by the FDA.
Data from patients under EIND has been promising. The first five patients with mild-to-moderate infection have been removed from oxygen. The company reported blood samples data last week from severely ill COVID-19 patients receiving leronlimab under EIND. The data demonstrated that patients had encouraging immune restoration as well as dramatic reduction in the critical cytokine storm (excessive or uncontrolled levels of immune response) after seven days of treatment. Patients are also benefiting from leronlimab treatment with them being removed from external ventilation or extubated within seven days.
CytoDyn remains hopeful that similar therapeutic benefits in patients treated in two clinical studies will pave way for an FDA approval for leronlimab as a COVID-19 treatment. It has also collaborated with the United Kingdom’s Department of Health for emergency access to leronlimab for severe and critically ill COVID-19 patients.
We note that, the company’s leronlimab is being developed for multiple cancer indications. In a separate press release, the company announced that the first patient was treated with the candidate in a phase II basket study evaluating it for 22 solid cancer tumors. However, patient enrolment in the study has been delayed due to COVID-19.
CytoDyn’s shares have surged 140% so far this year against the industry’s decline of 15.9%.
Several large pharma companies have joined the race to develop an effective treatment for the deadly coronavirus infection, which has affected more than 2 million people globally with the death toll rising to more than 138,000.
Earlier this week, AstraZeneca (AZN - Free Report) announced plans to begin a global clinical study soon to evaluate its blood cancer drug, Calquence, for treating exaggerated immune response associated with COVID-19 infection in severely ill patients. Lilly (LLY - Free Report) in partnership with the National Institute of Allergy and Infectious Diseases will evaluate its rheumatoid arthritis drug, Olumiant, as a potential treatment for hospitalized patients diagnosed with COVID-19. Other large pharma companies evaluating their marketed drugs as a potential COVID-19 treatment include Sanofi (SNY - Free Report) and Roche.
Gilead is also developing its antiviral candidate, remdesivir, in patients hospitalized with severe complications of COVID-19. Earlier this week, the company announced data from patients receiving treatment with the candidate under compassionate use program, which showed that the majority of patients demonstrated clinical improvement.
CytoDyn Inc. Price
CytoDyn Inc. price | CytoDyn Inc. Quote
Zacks Rank
CytoDyn currently carries a Zacks Rank #2 (Buy). 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.
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