Healios Advances MultiStem Approval for ARDS in Japan

Healios KK ( (JP:4593) ) has shared an update.

Healios K.K. announced a significant step in their application for conditional and time-limited approval of MultiStem for ARDS in Japan, following a consultation with the Pharmaceuticals and Medical Devices Agency (PMDA). The agreement on the clinical data package, along with previous agreements on manufacturing methods, supports Healios’s strategy to use existing Phase 2 trial data from Japan, the U.S., and the U.K., while a pivotal Phase 3 trial in the U.S. will serve as a confirmatory study. This progress is aligned with their development strategy and highlights the potential impact of MultiStem in addressing the unmet need for ARDS treatments.

More about Healios KK

Healios K.K. operates in the regenerative medicine industry, focusing on developing and distributing the MultiStem product, a stem cell therapy for conditions like ischemic stroke and acute respiratory distress syndrome (ARDS). The company holds exclusive rights to MultiStem in Japan and has expanded its license globally, with the product receiving fast track and RMAT designation from the FDA.

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