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Regeneron's (REGN) Inmazeb Ebola Treatment Gets FDA Approval

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Regeneron Pharmaceuticals, Inc. (REGN - Free Report) announced that the FDA has approved its triple antibody cocktail, REGN-EB3, under the brand name, Inmazeb, for the treatment of the infection caused by Zaire ebolavirus in adult and pediatric patients. The patient population includes newborns of mothers who have tested positive for the infection.

Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) is a novel anti-viral antibody medicine.  The drug showed superiority compared to other investigational agents — ZMapp and Gilead Sciences’ (GILD - Free Report) remdesivir — with respect to mortality in the PALM study.

Per Regeneron, this is the first time the FDA has approved a treatment specifically for Ebola.

Regeneron will deliver a significant number of Inmazeb treatment doses over the course of six years to the Biomedical Advanced Research and Development Authority (BARDA), as part of an agreement announced in July 2020.

We note that in December 2019, the FDA approved Merck’s (MRK - Free Report) vaccine, Ervebo, for the prevention of Ebola in individuals 18 years of age and older.

Regeneron’s shares have surged 59.4% in the year so far compared with the industry’s growth of 1.8%.


The company has been in the news, of late, after its antibody treatment, REGN-COV2, for COVID-19 was hailed by President Donald Trump who was administered the same after he tested COVID-19 positive.

Regeneron submitted a request to the FDA for an Emergency Use Authorization (EUA) for REGN-COV2.

REGN-COV2's development and manufacturing have been funded in part with federal funds from BARDA. Regeneron has recently partnered with Roche (RHHBY - Free Report) to increase the global supply of the candidate.

Currently, there are no FDA-approved treatments for the severe illness caused by SARS-CoV-2. The pharma/biotech sector is racing against time to come up with treatments and vaccines to cure the contagion. Given the alarming levels of the spread and severity of the pandemic, quite a few biotechs are developing antibodies or evaluating their approved drugs or pipeline candidates to determine if they are effective enough to treat the infected patients. The FDA earlier granted an EUA to remdesivir for the COVID-19 infection.

Regeneron currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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