Healios Launches Japan Arm of Global Phase 3 Trial for ARDS Stem Cell Therapy

An update from Healios KK ( (JP:4593) ) is now available.

Healios K.K. has begun preparations to initiate patient enrollment in Japan for the global Phase 3 REVIVE-ARDS trial of its stem cell therapy HLCM051 (invimestrocel) in pneumonia-induced acute respiratory distress syndrome (ARDS), following completion of regulatory review by the Pharmaceuticals and Medical Devices Agency. The pivotal, placebo-controlled, double-blind study, which will enroll up to 550 patients across the U.S., Japan, Asia-Pacific and Europe, uses ventilator-free days as the primary endpoint and includes interim analyses that may allow early termination if efficacy is confirmed, underscoring the potential for Healios to advance a first-in-class therapy in a high-mortality condition with no approved drugs that directly improve prognosis, although the company does not expect a near-term impact on its 2026 financial results.

The most recent analyst rating on (JP:4593) stock is a Hold with a Yen358.00 price target. To see the full list of analyst forecasts on Healios KK stock, see the JP:4593 Stock Forecast page.

More about Healios KK

Healios K.K. is a leading Japanese clinical-stage biotechnology company focused on regenerative medicine, developing stem cell-based therapies for diseases with limited treatment options. The company is a pioneer in Japan’s regenerative medicines field and owns proprietary global platforms utilizing both somatic stem cells and induced pluripotent stem (iPS) cells, including its multipotent adult progenitor cell-based product invimestrocel (HLCM051).

Average Trading Volume: 3,949,841

Technical Sentiment Signal: Sell

Current Market Cap: Yen44.21B

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