Regeneron Seeking Early Use Authorization For COVID-19 Antibody Therapy
Regeneron Seeking Early Use Authorization For COVID-19 Antibody Therapy
… Regeneron’s COVID-19 Antibody Treatment Shows Promise …


Another potential treatment option for SARS-CoV-2

John G. Baresky

Regeneron (NASDAQ: REGN) is excited about the promising clinical trial research results it is achieving with its COVID-19 antibody treatment candidate REGEN-COV2. They are having conversations with the U.S. Food and Drug Administration (FDA) about receiving Emergency Use Authorization (EUA) clearance for REGEN-COV2 to accelerate the product’s availability to the marketplace.

Initial patient care performance of REGEN-COV2 is good

Regeneron has multiple REGEN-COV2 clinical trials underway

The Phase 3 prevention trial is being conducted with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The safety of REGEN-COV2 is being further evaluated in a Phase 1 healthy volunteer study.

REGN-COV2 is a genetically-engineered therapy

Thus far its progress has been optimistically positive and Regeneron continues to assertively support its clinical and commercial development phases leading up to their FDA request for emergency use authorization. Regeneron has produced enough doses for about 50,000 patients now and expects to be able to provide enough units to care for approximately 300,000 patients in total.

They are working with Swiss-based Roche to increase the production of REGN-COV2 for U.S. and worldwide markets. Roche would have commercial marketing and sales rights to REGEN-COV2 in markets outside of the United States. A global healthcare heavy hitter, Roche is already in the thick of the action in the battle against COVID-19 and has substantial initiatives underway in its pharmaceutical and diagnostic business units.

Regeneron is on a roll in 2020

Just recently their triple monoclonal antibody (mAb) therapy, Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn) was approved by the FDA for the treatment of Zaire ebolavirus (Ebola virus) in adult and pediatric patients (including neonates born to a mother who is RT-PCR positive for Zaire ebolavirus infection).

In 2019 Tarrytown, New York-based Reneneron produced over $7.8 billion in revenue driven by a 17% increase in sales. Employing over 7,000 staff members, Regeneron’s success moving forward with REGN-COV2 is highly anticipated by patients, medical professionals, governments and investors.

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