Roche Gets Emergency FDA Approval For Covid-19 Antibody Test, Starts Shipping

Switzerland’s Roche Holding AG (RHHBY) announced on Sunday that its antibody test, which seeks to determine if an individual has been infected with the coronavirus, has received emergency approval by the U.S. Food and Drug Administration (FDA).   

“We are now able to deliver a high-quality antibody test in high quantities, so we can support healthcare systems around the world with an important tool to better manage the COVID-19 health crisis,” said Severin Schwan, CEO of the Roche Group. ”I am in particular pleased about the high specificity and sensitivity of our test, which is crucial to support health care systems around the world with a reliable tool to better manage the COVID-19 health crisis.”

The Swiss drugmaker said it has already started shipping the antibody tests to leading laboratories around the world and will ramp up production capacity to provide “high double-digit millions” of tests in May to healthcare systems in countries accepting the European CE regulatory mark as well as the U.S.

The antibody test, which has a specificity greater than 99.8% and 100% sensitivity aims to help assess patients’ immune response to the virus, the drugmaker said.

HSBC analyst Stephen McGarry on Thursday raised the stock to Hold from Sell, saying that the drugmaker represents one of the more secure bets within the pharmaceutical sector.

McGarry noted that compared to other industries, sales and cash flows of the pharmaceutical industry in the Covid-19 realm are well protected.

The two Wall Street analysts covering the stock in the past three months are split between a Buy and a Hold rating adding up to a Moderate Buy consensus rating. The $48 average price target indicates that they see 12% upside potential in the shares in the next 12 months.

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