- The FDA designates Athersys' (NASDAQ:ATHX) MultiStem cell therapy a Regenerative Medicine Advanced Therapy (RMAT) for the potential treatment of acute respiratory distress syndrome (ARDS).
- RMAT status includes all the benefits of Fast Track and Breakthrough Therapy, including early interactions with the FDA, more intensive agency guidance on development and a rolling review of the marketing application.
- An open-label Phase 2/3 clinical trial, MACoVIA, evaluating MultiStem in COVID-19-induced ARDS is in process. The primary endpoints are safety/tolerability and ventilator-free days through day 28 compared to placebo. The estimated primary completion date is September 2021.
- Shares up 6% premarket on light volume.
- Quant rating is Neutral.