FDA Grants Exicure’s Merkel Cell Carcinoma Treatment Orphan Drug Designation

March 8, 2021

The FDA has granted Orphan Drug status to Exicure’s Merkel cell carcinoma (MCC) treatment candidate, cavrotolimod (AST-008).

The FDA had previously granted two Fast-Track designations for cavrotolimod for MCC and cutaneous squamous cell carcinoma, both in advanced/metastatic stages after progression on anti-PD-1/PD-L1 antibodies.

Under the Orphan Drug designation, Exicure will have access to tax credits for qualified clinical trials and fee waivers, in addition to seven years of market exclusivity for cavrotolimod should it receive approval.

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