Regeneron Pharmaceuticals Inc. (REGN) - Get Report shares spiked higher in pre-market trading Monday after the drugmaker received emergency approval for its coronavirus cocktail therapy from the U.S. Food & Drug Administration.
Regeneron said its REGN-COV2 treatment, a combination of two monoclonal antibodies designed to prevent the infectivity of SARS-CoV-2, the virus that causes COVID-19, was granted Emergency Use Authorization (EUA) from the FDA Sunday. Regeneron said the approval is for individuals who are at high risk for progressing to severe COVID-19 or possible hospitalization.
President Donald Trump was injected with the treatment last month, according to his physicians, and claimed in a video released during his hospitalization and suggested that "it just me me better. I call that a cure."
"This FDA Emergency Use Authorization is an important step in the fight against COVID-19, as high-risk patients in the United States will have access to a promising therapy early in the course of their infection," said CEO Leonard Schleifer. "The science and technology investments Regeneron has made over three decades positioned us to move rapidly to invent, study and maximize production of REGEN-COV2."
"Even with these incredible efforts, demand may exceed supply initially, making it even more critical that federal and state governments ensure REGEN-COV2 is distributed fairly and equitably to the patients most in need," he added. "In the first quarter of 2021, we expect to increase available REGEN-COV2 global supply as we continue our collaboration with Roche."
Regeneon shares were marked 0.14% higher in early trading Monday following news of the EUA approval to change hands at $519.48 each, a move that nudges the stock into positive territory over the past six months.
Regeneron's REGN-COV2, is undergoing a jointly run trial with the National Institute of Allergy and Infectious Diseases, of 2,000 people, as well as a separate study of 2,900 coronavirus patients who are in hospitals and ambulatory settings.
"The clinical evidence from Regeneron's outpatient trial suggests that monoclonal antibodies such as REGEN-COV2 have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load," the company said.