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Regeneron (REGN - Free Report) and partner Roche (RHHBY - Free Report) announced that the European Medicines Agency's (“EMA”) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the antibody cocktail of casirivimab and imdevimab.
The CHMP recommends approval of the cocktail for patients aged 12 years and older for the treatment of non-hospitalized patients (outpatients) with confirmed COVID-19 who do not require oxygen supplementation and who are at increased risk of progressing to severe COVID-19, and to prevent the disease.
The cocktail is known as REGEN-COV in the United States and Ronapreve in the European Union and other countries. Regeneron invented the antibody cocktail. A final decision from the European Commission regarding the approval of the antibody cocktail is expected in the near future.
The recommendation is based on positive data from the REGN-COV 2067 treatment study in non-hospitalized patients and the REGN-COV 2069 prophylaxis study in people exposed to SARS-CoV-2 virus.
Roche is primarily responsible for the development and distribution of the cocktail outside the United States.
In addition to this Marketing Authorization Application (MAA), Regeneron and Roche plan to submit a future Type II Variation to the EMA that seeks to expand the potential indication to include the treatment of patients hospitalized because of COVID-19.
We note that the cocktail is not approved by the FDA, but is currently authorized under an Emergency Use Authorization (EUA) for use in certain post-exposure prophy and as a treatment for non-hospitalized people with mild to moderate COVID-19 who are at high risk of serious consequences from COVID-19.
Last month, the FDA accepted for priority review the first of two biologics license applications (BLAs) for REGEN-COV to treat COVID-19 in non-hospitalized patients and as prophylaxis in certain individuals. The second BLA submission will focus on those hospitalized because of COVID-19 and is expected to be completed later this year.
Regeneron’s shares have gained 29.7% in the year so far against the industry’s decline of 14.2%.
Image Source: Zacks Investment Research
In September, Regeneron announced a new agreement with the U.S. government to supply an additional 1.4 million 1,200 mg doses of REGEN-COV by January 2022.
Meanwhile, the FDA has also issued an EUA for Vir Biotechnology (VIR - Free Report) and GlaxoSmithKline’s (GSK - Free Report) investigational monoclonal antibody therapy sotrovimab for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients. The CHMP is conducting a rolling review of data on sotrovimab to support a forthcoming MAA. Vir and Glaxo now plan to submit a BLA to the FDA in the first half of 2022.
Vir and Glaxo also continue to advance trials evaluating intramuscular (IM) administration of sotrovimab to increase patient access and convenience.
Image: Bigstock
Regeneron (REGN)-Roche COVID-19 Cocktail Gets Positive CHMP Opinion
Regeneron (REGN - Free Report) and partner Roche (RHHBY - Free Report) announced that the European Medicines Agency's (“EMA”) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the antibody cocktail of casirivimab and imdevimab.
The CHMP recommends approval of the cocktail for patients aged 12 years and older for the treatment of non-hospitalized patients (outpatients) with confirmed COVID-19 who do not require oxygen supplementation and who are at increased risk of progressing to severe COVID-19, and to prevent the disease.
The cocktail is known as REGEN-COV in the United States and Ronapreve in the European Union and other countries. Regeneron invented the antibody cocktail. A final decision from the European Commission regarding the approval of the antibody cocktail is expected in the near future.
The recommendation is based on positive data from the REGN-COV 2067 treatment study in non-hospitalized patients and the REGN-COV 2069 prophylaxis study in people exposed to SARS-CoV-2 virus.
Roche is primarily responsible for the development and distribution of the cocktail outside the United States.
In addition to this Marketing Authorization Application (MAA), Regeneron and Roche plan to submit a future Type II Variation to the EMA that seeks to expand the potential indication to include the treatment of patients hospitalized because of COVID-19.
We note that the cocktail is not approved by the FDA, but is currently authorized under an Emergency Use Authorization (EUA) for use in certain post-exposure prophy and as a treatment for non-hospitalized people with mild to moderate COVID-19 who are at high risk of serious consequences from COVID-19.
Last month, the FDA accepted for priority review the first of two biologics license applications (BLAs) for REGEN-COV to treat COVID-19 in non-hospitalized patients and as prophylaxis in certain individuals. The second BLA submission will focus on those hospitalized because of COVID-19 and is expected to be completed later this year.
Regeneron’s shares have gained 29.7% in the year so far against the industry’s decline of 14.2%.
In September, Regeneron announced a new agreement with the U.S. government to supply an additional 1.4 million 1,200 mg doses of REGEN-COV by January 2022.
Meanwhile, the FDA has also issued an EUA for Vir Biotechnology (VIR - Free Report) and GlaxoSmithKline’s (GSK - Free Report) investigational monoclonal antibody therapy sotrovimab for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients. The CHMP is conducting a rolling review of data on sotrovimab to support a forthcoming MAA. Vir and Glaxo now plan to submit a BLA to the FDA in the first half of 2022.
Vir and Glaxo also continue to advance trials evaluating intramuscular (IM) administration of sotrovimab to increase patient access and convenience.
Regeneron currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.