Healios KK (JP:4593) has released an update.
Healios KK is set to consult with the FDA in September 2024 to initiate a global Phase 3 study for MultiStem, a treatment for ARDS caused by pneumonia, building on positive Phase 2 results and an ongoing Phase 3 study in Japan. The company, having recently acquired the worldwide rights to MultiStem, aims to expedite U.S. development with Fast Track and RMAT designations and seeks conditional approval in Japan. Details on the U.S. trial and Japanese approval will be disclosed once conditions allow, with no current impact on the 2024 fiscal financial results.
For further insights into JP:4593 stock, check out TipRanks’ Stock Analysis page.
