Healios K.K Gets FDA Nod for Global ARDS Phase 3 Trial; Shares Up 10%

Healios K.K (TYO:4593), a biotech firm specializing in regenerative medicine, has secured FDA approval for its global Phase 3 trial, "REVIVE-ARDS," to test MultiStem for acute respiratory distress syndrome (ARDS) caused by pneumonia, according to a Monday filing on the Tokyo Stock Exchange.

The trial will use ventilator-free days as the primary endpoint and include interim analyses of 300 and 400 patients, with a maximum of 550 participants.

The company will finalize study details and consult Japanese regulators for conditional approval based on previous positive Phase 2 results. Shares of the company were up 10% in recent trade.

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