Capricor Therapeutics (CAPR) said Wednesday that the European Medicines Agency granted orphan drug and advanced therapy medicinal product designations to its lead asset deramiocel to treat Duchenne muscular dystrophy.
The orphan drug label will allow Capricor to back the development of deramiocel in Europe, including a 10-year market exclusivity period if approval is obtained, the company said.
The other designation will give the company regulatory backing to help in the development of cell-based treatments, Capricor said.
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