14 May 2019 - Athersys announced today that its clinical program evaluating MultiStem cell therapy for the treatment of acute respiratory distress syndrome has received fast track designation from the United States FDA. 

This important designation is given to qualified investigational therapies that show promise in providing benefit to patients in areas of significant unmet medical need. Fast Track designation allows for an expedited regulatory review process after the clinical data is submitted to help speed development of promising therapies to the market in order to help patients in areas where current standard of care is limited.

In January 2019, the Company announced favourable top-line results from a randomised, double-blind placebo-controlled exploratory Phase 2 clinical study evaluating MultiStem administration to patients with ARDS, referred to as the MUST-ARDS study.

Read Athersys press release