Regeneron Pharmaceuticals Inc. (REGN) - Get Report shares jumped higher Monday amid speculation the drugmaker could soon receive Emergency Use Authority from the Food & Drug Administration after its coronavirus treatment was given to President Donald Trump.
Trump's doctors said over the weekend that he received an infusion of Regeneron's dual antibody treatment for COVID-19, which is currently being studied for its use in early infections but has not yet been approved by the FDA for broader use, after testing positive for the virus on Thursday.
The drug, known as 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 President's infusion, however, suggests the double-cocktail could be granted Emergency Use Authorization (EUA) from the FDA in the coming weeks.
"It is hard to see that this emergency use is not a tacit endorsement by the Federal medical bureaucracy for REGN’s medicine, and we expect an EUA for the treatment of COVID in a matter of days," said SVB Leerink analyst Geoffrey Porges. "There are certainly risks for Regeneron in providing their antibody to the President in such circumstances, but both the company and the White House’s medical staff are likely to have had access to much more information about REGN-COV2 than the company has disclosed publicly so far."
"Given those circumstances, it seems likely that the full dataset for the treatment will be as good or better than the initial 275 patients from one trial disclosed last week," he added.
Regeneron shares were marked 6.2% higher in early trading Monday to change hands at $599.47 each, a move that could extend the stock's six-month gain to around 18.4%