Regeneron (REGN) Said Trump-Taken COVID-19 Antibody Cocktail Cuts Viral Load, Analysts See Case for FDA Emergency Use Approval

Regeneron (NASDAQ: REGN) share price trades about 2% higher in pre-open Thursday after the company said its antibody cocktail - the same one used by President Trump - "significantly reduced" COVID-19 levels and the need for "further medical attention".

Regeneron said the cocktail, REGN-COV2, reduced COVID-19 related medical visits by 57% through day 29. Further, it reduced COVID-19 related medical visits by 72% in patients with one or more risk factors. Those risk factors included being over 50 years of age, a body mass index greater than 30, cardiovascular, metabolic, lung, liver or kidney disease, or an immunocompromised status.

"We continue to see the strongest effects in patients who are most at risk for poor outcomes due to high viral load, ineffective antibody immune response at baseline, or pre-existing risk factors," Regeneron's President and Chief Scientific Officer George D. Yancopoulos said in a statement.

Regeneron shared the data from the ongoing Phase II trial, including an additional 524 patients.

“Regeneron has shared these results with the U.S. FDA, which is reviewing an Emergency Use Authorization submission for the REGN-COV2 low dose in adults with mild-to-moderate COVID-19 who are at high risk for poor outcomes,” the company said in a statement.

According to the pharma giant, the study met the primary and key secondary endpoints after evidence that its REGN-COV2 cocktail significantly reduced viral load and patient medical visits.

"The first job of an antiviral therapeutic drug is to lower the viral load, and our initial data in 275 patients strongly suggested that the REGN-COV2 antibody cocktail could lower viral load and thereby potentially improve clinical outcomes. Today's analysis, involving more than 500 additional patients, prospectively confirms that REGN-COV2 can indeed significantly reduce viral load and further shows that these viral reductions are associated with a significant decrease in the need for further medical attention," added Yancopoulos.

Guggenheim's analyst Yatin Suneja believes that REGN will receive an EUA from the FDA.

“While we are not clear on the level of viral reduction that's necessary to substantially reduce disease, the improvement on the key clinical endpoint gives us comfort that this level of viral load reduction does provide disease relief, at least in a portion of the patient population,” Suneja said in a note.

“Given the relative limited reach of this drug (~50,000 doses available now, manufacturing capacity of ~50,000 per month), we believe REGN-COV2, if approved, will likely be directed primarily towards prophylactic treatment of at-risk patients (the elderly, patients with co-morbidities, and possibly patients on immunosuppressive drugs), as well as medical personnel, who are more likely to come into contact with the virus.”

The updated COVID-19 data is supportive of the EUA, Jefferies’ Biren Amin also writes in today’s note.

“Data shows stat sig reduction on both viral load and medical visit endpoints among all pts. However, improvements in symptom alleviation were not clear in this update whereas the last update observed improvement in sero(-) pts, and even LLY's BLAZE-1 observed improvements in symptoms. We believe the data is supportive of an EUA.”

Both firms rate REGN with a “Buy” rating.

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