FDA Grants Orphan Drug Designation For Mithridion's MCD-386CR
Orphan status entitles Mithridion to seven years of market exclusivity upon approval of MCD-386 for treating PSP.
Mithridion, Inc., a clinical stage drug development company focusing on serious Central Nervous System (CNS) disorders, announces that the US FDA has awarded Orphan Drug designation for MCD-386CR, its lead drug candidate, for the treatment of Progressive Supranuclear Palsy (PSP).
Orphan status entitles Mithridion to seven years of market exclusivity upon approval of MCD-386 for treating PSP, and to apply for grant funding to contribute to clinical trial costs, tax credits, and a waiver of certain FDA fees. Orphan status is intended to encourage the development of drugs for diseases affecting fewer than 200,000 persons in the USA.
PSP is a progressive brain disease in which neurons degenerate in regions of the brain vital for eye movements, balance, walking, spee
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