Steminent Biotherapeutics Inc.

REPROCELL Submits Application for Stem Cell Therapy Stemchymal in Japan for Spinocerebellar Ataxia SCA3 and SCA6

- REPROCELL Inc. has submitted an application for manufacturing and marketing approval in Japan for Stemchymal, a regenerative medicine product targeting spinocerebellar ataxia types SCA3 and SCA6. - Stemchymal was granted Orphan Regenerative Medicine Product designation by Japan's MHLW in December 2018, qualifying it for PMDA priority review with a nine-month target review period. - The therapy aims to suppress the progression of ataxia in patients with SCA3 and SCA6, addressing a profound unmet medical need where limited effective treatments currently exist. - Stemchymal will be manufactured by Taiwan-based Steminent Biotherapeutics Inc., with REPROCELL overseeing all sales and distribution activities within Japan.