Healios K.K Submits Approval Application for ARDS Treatment in Japan

MT Newswires Live

03-13

Healios K.K (TYO:4593) plans to submit a conditional and time-limited approval application in Japan for HLCM051, following positive results from the Phase 2 ONE-BRIDGE study in Japan and the MUST-ARDS study in the US and UK.

The upcoming global Phase 3 REVIVE-ARDS trial in the US will serve as a confirmatory study, according to its Thursday bourse filing.

A portion of the data for this application, highlighting the efficacy of HLCM051 in extending ventilator-free days and reducing mortality, has been published in the journal Regenerative Therapy.

This publication, led by Dr. Kazuya Ichikado, boosts the credibility of the submission.

Price (JPY): $278.00, Change: $+2.0, Percent Change: +0.72%

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