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Healios K.K. Seeks ARDS Therapy Approval in Japan

Healios K.K. Seeks ARDS Therapy Approval in Japan

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

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Healios K.K. has announced its decision to apply for conditional and time-limited approval in Japan for its MultiStem® therapy for acute respiratory distress syndrome (ARDS), based on positive Phase 2 trial results. The company plans to launch a global Phase 3 trial in the U.S. and has cancelled a previously planned Phase 3 trial in Japan. Healios has stated that this development will not affect its consolidated financial results for the fiscal year ending December 31, 2024.

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