SanBio eyes U.S. re-entry after Akuugo approval

SanBio Company Limited (TSE:4592) announced its financial results for the fiscal year ending January 31, 2025, highlighting a strategic focus on global expansion. The company reported operating expenses of ¥3.516 billion, primarily related to its SB623 Chronic Traumatic Brain Injury Program. SanBio secured conditional approval in Japan for its AKUUGO® suspension for intracranial implantation, a first-of-its-kind regenerative therapy. With this momentum, SanBio is eyeing a return to the U.S. market and is planning to resume discussions with the FDA for clinical trials related to traumatic brain injury and ischemic stroke. Additionally, Sanbio will be pursuing partnerships for clinical trials and considering in-house development options for ischemic stroke. The company is projecting business expenses of ¥3.509 billion for the next fiscal year, driven by activities related to AKUUGO® manufacturing and distribution.