REPROCELL Submits Application for Manufacturing and Marketing Approval in Japan for Stem Cell Therapy Stemchymal® for Spinocerebellar Ataxia (SCA3 and SCA6)
Summary
REPROCELL submitted an application in Japan for manufacturing and marketing approval of Stemchymal® for spinocerebellar ataxia types 3 and 6. The therapy already has orphan regenerative medicine designation, which can speed regulatory review. REPROCELL said Stemchymal® will be manufactured by Steminent Biotherapeutics in Taiwan while REPROCELL handles sales and distribution in Japan. The company sees the filing as a modest near-term financial event but an important long-term growth catalyst.
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Biotechnology
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Steminent Corp
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