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In Response to FDAs Release of Full CRL for Deramiocel, Capricor Publishes Full Response to the Agency September 9, 2025 Following the FDAs public release of the full Capricor stated that it was not notified in advance by the FDA that the latter would be DTX401 Indication: Glycogen storage disease type Ia (GSDIa)

It does not appear toxic, does not accumulate in tissues, and has been well tolerated in trials

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Patients showed an average reduction of 13.7% of body weight with semaglutide