Healios (TYO:4593)will submit a clinical trial application for a global Phase 3 Acute Respiratory Distress Syndrome (ARDS) study in early 2026, according to its Tokyo bourse filing on Tuesday.

The group said this after shifting its development strategy for the regenerative medicine HLCM051 (invimestrocel), now prioritizing its advancement as a treatment for ARDS in the near term.

Concurrently, Healios has decided not to pursue a rolling submission for conditional approval of HLCM051 for ischemic stroke by the end of 2025 or early 2026, citing ongoing regulatory discussions and the need to allocate resources effectively.

The company will continue its dialogue with regulators to reevaluate the stroke program's development path at a later date.