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Regeneron (REGN) Resumes Enrollment in Lymphoma Cohorts
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Regeneron Pharmaceuticals, Inc. (REGN - Free Report) announced that it has resumed enrollment in its monotherapy studies of pipeline candidate, odronextamab, a CD20xCD3 bispecific antibody.
The company resumed enrolling patients with follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL) in the studies after the FDA agreed to lift the partial clinical trial hold for those patient cohorts.
We remind investors that in December 2020, Regeneron paused new enrollment of patients with B-cell non-Hodgkin lymphomas (B-NHL) in studies as the FDA had put a partial clinical hold. The agency requested that the company amend the trial protocols in order to further reduce the incidence of ≥Grade 3 cytokine release syndrome (CRS) during step-up dosing.
As a result, Regeneron amended the trial protocols and will recommence enrollment in these patient cohorts effective immediately (trials NCT02290951 and NCT03888105).
Separately, Regeneron announced detailed results from a phase III study on antibody cocktail, REGEN-COV (casirivimab with imdevimab). The data was presented at the 2021 American Thoracic Society International Conference (ATS 2021).
The phase III, randomized, double-blind, placebo-controlled trial evaluated two doses of REGEN–COV in 4,567 high-risk outpatients with COVID-19. The two REGEN-COV doses studied in the trial were the currently authorized 2,400 mg dose and a 1,200 mg dose under evaluation with the FDA. All patients evaluated for efficacy had at least one risk factor for severe COVID-19, such as chronic lung disease (including asthma), obesity, cardiovascular disease or being at least 50 years of age.
These data showed that REGEN-COV reduced the risk of hospitalization or death by 70% in non-hospitalized COVID-19 patients. Patients treated with REGEN-COV had a 4-day shorter duration of symptoms and significantly reduced viral load compared to placebo.
Additionally, Regeneron and partner Sanofi (SNY - Free Report) announced detailed results from a phase III study on Dupixent (dupilumab) at ATS 2021. Results showed that Dupixent significantly reduced severe asthma attacks and within two weeks rapidly improved lung function in children aged 6 to 11 years with uncontrolled moderate-to-severe asthma, with evidence of type 2 inflammation. The drug also significantly improved overall asthma symptom control and reduced an airway biomarker of type 2 inflammation that plays a major role in asthma.
A decision from the FDA for this indication is expected by Oct 21, 2021.
The company's shares have gained 7.8% in the year so far against the industry’s decline of 5.7%.
Regeneron’s first-quarter results were strong with broad-based growth. Demand for lead drug, Eylea, in collaboration with Bayer (BAYRY - Free Report) , revived. Dupixent maintained its strong performance. Incremental contribution from REGEN-COV boosted the top line and should propel sales as the pandemic continues.
Repligen’s earnings estimates for 2021 have increased to $2.21 from $1.66 in the past 90 days.
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Regeneron (REGN) Resumes Enrollment in Lymphoma Cohorts
Regeneron Pharmaceuticals, Inc. (REGN - Free Report) announced that it has resumed enrollment in its monotherapy studies of pipeline candidate, odronextamab, a CD20xCD3 bispecific antibody.
The company resumed enrolling patients with follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL) in the studies after the FDA agreed to lift the partial clinical trial hold for those patient cohorts.
We remind investors that in December 2020, Regeneron paused new enrollment of patients with B-cell non-Hodgkin lymphomas (B-NHL) in studies as the FDA had put a partial clinical hold. The agency requested that the company amend the trial protocols in order to further reduce the incidence of ≥Grade 3 cytokine release syndrome (CRS) during step-up dosing.
As a result, Regeneron amended the trial protocols and will recommence enrollment in these patient cohorts effective immediately (trials NCT02290951 and NCT03888105).
Separately, Regeneron announced detailed results from a phase III study on antibody cocktail, REGEN-COV (casirivimab with imdevimab). The data was presented at the 2021 American Thoracic Society International Conference (ATS 2021).
The phase III, randomized, double-blind, placebo-controlled trial evaluated two doses of REGEN–COV in 4,567 high-risk outpatients with COVID-19. The two REGEN-COV doses studied in the trial were the currently authorized 2,400 mg dose and a 1,200 mg dose under evaluation with the FDA. All patients evaluated for efficacy had at least one risk factor for severe COVID-19, such as chronic lung disease (including asthma), obesity, cardiovascular disease or being at least 50 years of age.
These data showed that REGEN-COV reduced the risk of hospitalization or death by 70% in non-hospitalized COVID-19 patients. Patients treated with REGEN-COV had a 4-day shorter duration of symptoms and significantly reduced viral load compared to placebo.
Additionally, Regeneron and partner Sanofi (SNY - Free Report) announced detailed results from a phase III study on Dupixent (dupilumab) at ATS 2021. Results showed that Dupixent significantly reduced severe asthma attacks and within two weeks rapidly improved lung function in children aged 6 to 11 years with uncontrolled moderate-to-severe asthma, with evidence of type 2 inflammation. The drug also significantly improved overall asthma symptom control and reduced an airway biomarker of type 2 inflammation that plays a major role in asthma.
A decision from the FDA for this indication is expected by Oct 21, 2021.
The company's shares have gained 7.8% in the year so far against the industry’s decline of 5.7%.
Regeneron’s first-quarter results were strong with broad-based growth. Demand for lead drug, Eylea, in collaboration with Bayer (BAYRY - Free Report) , revived. Dupixent maintained its strong performance. Incremental contribution from REGEN-COV boosted the top line and should propel sales as the pandemic continues.
Regeneron currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is Repligen Corp. (RGEN - Free Report) , which carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Repligen’s earnings estimates for 2021 have increased to $2.21 from $1.66 in the past 90 days.
Infrastructure Stock Boom to Sweep America
A massive push to rebuild the crumbling U.S. infrastructure will soon be underway. It’s bipartisan, urgent, and inevitable. Trillions will be spent. Fortunes will be made.
The only question is “Will you get into the right stocks early when their growth potential is greatest?”
Zacks has released a Special Report to help you do just that, and today it’s free. Discover 7 special companies that look to gain the most from construction and repair to roads, bridges, and buildings, plus cargo hauling and energy transformation on an almost unimaginable scale.
Download FREE: How to Profit from Trillions on Spending for Infrastructure >>