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Athersys cell therapy nabs accelerated review in U.S. for acute respiratory distress syndrome

Sep. 23, 2020 6:38 AM ETAthersys, Inc. (ATHXQ) StockBy: Douglas W. House, SA News Editor19 Comments
  • 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. 

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