Healios Seals Deal with FDA for Phase 3 ARDS Study
Healios (TYO:4593) has reached an agreement with the Food and Drug Administration (FDA) on the design of the pivotal Phase 3 REVIVE-ARDS study for acute respiratory distress syndrome (ARDS) caused by pneumonia.
The study will measure the primary endpoint of Ventilator Free Days and include interim analyses at 300 and 400 patients, with a maximum enrollment of 550 patients, according to its filing on Monday.
Healios will also consult Japanese regulatory authorities for conditional approval, based on Phase 2 results and the initiation of the REVIVE-ARDS study.
Healios' shares gained nearly 4% recently.
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