FDA grants emergency authorization to two blood purification systems

The Food and Drug Administration (FDA) on Friday issued emergency use authorizations to blood purification devices manufactured by Terumo Corp. 4543, +0.13% and Marker Therapeutics Inc. MRKR, +1.74% in response to the COVID-19 pandemic. Terumo is a Japanese medical device maker. Marker is a clinical-stage immuno-oncology company based in Houston. An EUA does not mean that that the device has been approved by the FDA; it is an authorization granted during an emergency when there are no other treatment options available. The regulator said that the devices can be used for adult patients with COVID-19 who are being cared for in the intensive care unit and have confirmed or imminent respiratory failure to reduce the amount of cytokines in those patients. Some severely ill COVID-19 patients have had “cytokine storms” that can lead to organ failure and death. Year-to-date, Terumo’s stock is down 3.9%, while shares of Marker have dropped 39.2%. The S&P 500 SPX, +1.44% has dropped 13.6% since the beginning of 2020.
https://www.marketwatch.com/story/fda-grants-emergency-authorization-to-two-blood-purification-systems-2020-04-10