ALPMF - Astellas' ASP0367 Fast Track'd in U.S. for mitochondrial disorders

The FDA designates Astellas Pharma's (ALPMF) ASP0367 for Fast Track review for the potential treatment of primary mitochondrial myopathies, a group of disorders caused by mutations within the DNA of mitochondria.Phase 1-stage ASP0367 selectively modulates a nuclear hormone receptor called PPAR? which plays a role in the development of a range of chronic diseases like diabetes, obesity, atherosclerosis and cancer. The company acquired the candidate via its takeover of Mitobridge in 2018.Fast Track status provides for more frequent interaction with the FDA review team and a rolling review of the marketing application.

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Astellas' ASP0367 Fast Track'd in U.S. for mitochondrial disorders