Japan · Delayed Price · Currency is JPY SanBio Company Earnings Call Transcripts
Fiscal Year 2026
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AKUUGO received full approval for TBI in Japan, enabling commercialization after 25 years of development. Strong cash position supports increased R&D and expansion into the U.S. and new indications, with a focus on stroke and further global growth.
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Six-month results highlighted regulatory progress for AKUUGO, increased operating expenses, and strengthened financial stability with new bank credit lines. US phase III trial design for TBI was agreed with the FDA, and commercial launch in Japan is anticipated next year.
Fiscal Year 2025
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Secured world-first approval for AKUUGO, a brain regeneration drug, with launches in Japan and U.S. planned. Strong liquidity supports expansion into stroke and other indications, with key regulatory and manufacturing milestones expected this year.
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Marketing approval for Akugo, the first brain regeneration drug, marks a historic milestone, with global expansion and a robust financial position supporting future growth. Strategic focus includes U.S. market re-entry, stroke trials, and leveraging Japan's innovation engine.