Shares of Regeneron Pharmaceuticals, Inc. REGN gained 1.38% after it submitted a request to the FDA for an Emergency Use Authorization (EUA) for its experimental COVID-19 treatment, REGN-COV2.
REGN-COV2 is a combination of two monoclonal antibodies (REGN10933 and REGN10987) and was designed specifically to block the infectivity of SARS-CoV-2, the virus that causes COVID-19. It is being evaluated for both treatment and prevention of COVID-19.
Per the company, there are doses available for approximately 50,000 patients and it expects to have doses available for 300,000 patients in total within the next few months.
The antibody treatment was recently hailed by President Donald Trump who was administered the same after he tested COVID-19 positive. REGN-COV2 was provided to the President in response to an Individual Patient Investigational New Drug (IND) application, which is commonly known as “compassionate use”, requested by the President’s physicians.
Last week, Regeneron reported promising first data from a descriptive analysis of a seamless phase I/II/III study of REGN-COV2. Data showed that the candidate reduced the viral load and the time to alleviate symptoms in non-hospitalized patients with COVID-19. REGN-COV2 also showed positive trends in lowering medical visits. In addition, REGN-COV2 is currently being studied in a phase II/III clinical study for the treatment of COVID-19 in hospitalized patients, the phase III open-label RECOVERY study of hospitalized patients in the U.K. and a phase III study for the prevention of COVID-19 in household contacts of infected individuals.
REGN-COV2’s development and manufacturing have been funded in part with federal funds from the Biomedical Advanced Research and Development Authority (BARDA). The company has recently partnered with Roche RHHBY to increase the global supply of the candidate.
Regeneron’s shares have surged 60.6% in the year so far compared with the industry’s growth of 2.2%.
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.
Eli Lilly LLY too recently submitted an initial request to the FDA for granting an EUA to its antibody therapy candidate, LYCoV555, as a monotherapy for the treatment of higher-risk patients, who have recently been diagnosed with mild-to-moderate COVID-19.
Earlier, the FDA granted an EUA to Gilead Sciences’ GILD remdesivir for the COVID-19 infection. Multiple ongoing international phase III studies are evaluating the safety and efficacy of remdesivir for the treatment of SARS-CoV-2 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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