Healios Files Japan Trial Plan for Global Phase 3 ARDS Stem Cell Study

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

Healios K.K. has submitted a clinical trial plan notification to Japan’s Pharmaceuticals and Medical Devices Agency to begin domestic participation in the pivotal global Phase 3 REVIVE-ARDS study of its stem cell therapy HLCM051 (invimestrocel) for pneumonia-induced acute respiratory distress syndrome, with Japanese patient enrollment expected to start following a 14-day review period before expanding in parallel to other regions including the US, Asia-Pacific and Europe. The trial, designed as a randomized, placebo-controlled study of up to 550 patients with interim analyses and ventilator-free days as the primary endpoint, will serve as a key confirmatory study supporting the company’s strategy to seek conditional and time-limited approval for ARDS in Japan based on positive Phase 2 results, marking a significant step in advancing a potential first-in-class therapy in an area with no approved drugs that directly improve prognosis, though the company expects no immediate impact on its 2026 financial guidance.

The most recent analyst rating on (JP:4593) stock is a Sell with a Yen301.00 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 Japan-based biotechnology company listed on the Tokyo Stock Exchange Growth market that specializes in somatic stem cell regenerative medicines, with a key focus on developing its lead product candidate HLCM051 (invimestrocel) for indications such as acute respiratory distress syndrome (ARDS) and ischemic stroke, targeting high unmet medical needs in critical care settings worldwide.

Average Trading Volume: 3,201,216

Technical Sentiment Signal: Sell

Current Market Cap: Yen36.95B

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