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Regeneron Pharmaceuticals Seeks Emergency Approval From FDA

Regeneron has asked for an Emergency Use Authorization approval for its experimental coronavirus antibody treatment following praise for the drug from President Donald Trump.

Regeneron Pharmaceuticals  (REGN) - Get Free Report shares jumped higher Thursday after President Donald Trump praised its coronavirus antibody treatment and the drugmaker said it will seek emergency use authorization from the Food & Drug Administration. 

Regeneron said its REGN-COV2 treatment, a combination of two monoclonal antibodies, is designed to prevent the infectivity of SARS-CoV-2, the virus that causes COVID-19. The group has around 50,000 doses available for public use and said it would have doses available for "300,000 patients in total within the next few months" if the Emergency Use Authorization (EUA) is approved.

President Trump was injected with the treatment last week, according to his physicians, and he claimed in a video released late Wednesday to "feel good immediately" and suggested that "it just me me better. I call that a cure." 

Regeneron shares were marked 2.3% higher in early trading Thursday to change hands at $604.1 each, a move that would extend the stock's six-month gain to around 20%.

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.

Earlier on Wednesday, Eli Lilly & Co. filed an EUA application with the FDA trial data showing that the experimental antibody, Y-CoV555, met both primary and secondary endpoints. 

The drugmaker had earlier noted that the treatment, which is being manufactured in a joint arrangement with Amgen Inc.  (AMGN) - Get Free Report. reduced the need for hospitalization and emergency-room visits among patients with moderate coronavirus symptoms.

Eli Lilly said it's studying several neutralizing antibodes for the prevention and treatment of COVID-19, either in combination with other drugs or as a so-called monotherapy, adding that its collaboration with Amgen would "significantly increase the supply capacity" of any potential treatment breakthrough. 

Eli Lilly shares were marked 2% higher at $152.00. each, a move that pushes the stock's six-month gain to around 4%.