Healios K.K (TYO:4593) has completed regulatory consultations with Japan's Pharmaceuticals and Medical Devices Agency for its conditional approval application for HLCM051 (invimestrocel), a treatment for acute respiratory distress syndrome, according to a Wednesday filing on the Tokyo Stock Exchange.
The company will now include Japanese patients in the global Phase 3 revive-ARDS study, set to begin primarily in the US.
The trial aims to confirm efficacy based on ventilator-free days, with a maximum of 550 participants.
Shares of the company gained over 1% in Thursday's morning trade.
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