23 September 2020 - ARDS program well positioned for an expedited path to commercialisation with RMAT and fast track designation.
Athersys announced today that MultiStem cell therapy was granted regenerative medicine advanced therapy designation from the U.S. FDA for the acute respiratory distress syndrome program.
The RMAT designation for ARDS is granted in addition to the previously obtained Fast Track designation awarded in May 2019. MultiStem is the only cell therapy program for ARDS that has both fast track and RMAT designation from the FDA.
Read Athersys press release