Healios K.K (TYO:4593) has agreed with Japan's Pharmaceuticals and Medical Devices Agency (PMDA) on the clinical data package for conditional approval of MultiStem for Acute Respiratory Distress Syndrome, according to a Wednesday filing with the Tokyo Stock Exchange.
The approval will be based on Phase 2 trial results, with future Phase 3 data from the US as confirmatory support.
MultiStem is a regenerative medicine targeting ARDS, ischemic stroke, and trauma, and has received FDA Fast Track and RMAT designations.
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