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Regeneron (REGN) Reports Positive Data on Antibody Cocktail

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Regeneron Pharmaceuticals, Inc. REGN recently announced that a phase II/III randomized, double-blind, placebo-controlled study evaluating experimental antibody cocktail, REGEN-COV (casirivimab and imdevimab), in patients hospitalized with COVID-19 met its primary endpoint.

REGEN-COV is an investigational medicine authorized by the FDA under an emergency use authorization to treat people who are at high risk of serious consequences from COVID-19 infection. They are either already infected or are in certain post-exposure prophylaxis settings. However, it is not authorized for patients who are hospitalized due to COVID-19 infection in the United States.

Regeneron Pharmaceuticals, Inc. Price and Consensus

Regeneron Pharmaceuticals, Inc. Price and Consensus
Regeneron Pharmaceuticals, Inc. Price and Consensus

Regeneron Pharmaceuticals, Inc. price-consensus-chart | Regeneron Pharmaceuticals, Inc. Quote

Of the 1,197 patients included in the efficacy analysis, 530 entered the trial with no supplemental oxygen and 667 were on low-flow oxygen. Patients were randomized 1:1:1 to receive a one-time infusion of REGEN-COV 8,000 mg, REGEN-COV 2,400 mg, or placebo.

The study results showed that REGEN-COV significantly reduced viral load in patients hospitalized with COVID-19 who entered the trial without having mounted their own antibody response (seronegative) and required low-flow or no supplemental oxygen. REGEN-COV significantly reduced viral load within seven days of treatment.

It was also seen that patients who received REGEN-COV (2,400 mg or 8,000 mg) in addition to standard-of-care (SOC) experienced numeric improvements across all clinical endpoints assessed compared to SOC alone (placebo). There was no clinical difference between the two REGEN-COV doses (2,400 mg or 8,000 mg), or any serious or dose-dependent safety signals in REGEN-COV treated patients.

Patients who received REGEN-COV in this study experienced a 36% reduced risk of dying within 29 days of treatment, and in patients who were seronegative when they entered the trial, the risk was reduced by 56%.

This study was earlier stopped due to slow enrollment after recruiting just over one-third of the patients originally planned.

The FDA is currently reviewing the request to add treatment in hospital settings to REGEN-COV authorization.

Management stated that these new results combined with the nearly 10,000-patient RECOVERY trial validate the efficacy of REGEN-COV in treating patients even after they are hospitalized with COVID-19. Per multiple analyses, the antibody cocktail retains potency against the main variants of concern in the United States, including Delta, Gamma, Beta, and Mu.

In August, Regeneron submitted the first of two biologics license applications (BLAs) for REGEN-COV. The initial submission included data on the efficacy and safety of REGEN-COV to treat and prevent SARS-CoV-2 infection in non-hospitalized people. The second BLA submission will focus on those hospitalized because of COVID-19, and is expected to be completed later this year.

The company's shares have gained 25.3% in the year so far against the industry’s decline of 5.5%.

Zacks Investment Research
Zacks Investment Research

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The company recently announced that the U.S. Department of Health and Human Services and the Department of Defense will purchase 1.4 million additional doses of REGEN-COV. Incremental contribution from REGEN-COV has boosted the top line as the pandemic wreaks havoc with emerging deadly variants that question the efficacy of the vaccines. Regeneron has collaborated with Roche RHHBY to increase the supply of the cocktail.

The FDA has also granted an EUA to GlaxoSmithKline plc GSK and Vir Biotechnology, Inc. VIR’s sotrovimab, an investigational single-dose monoclonal antibody, for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients and the uptake has been encouraging.

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

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