Capricor Therapeutics granted ODD, ATMP status for deramiocel by EMA

Capricor Therapeutics (CAPR) announced that the European Medicines Agency, EMA, has granted both Orphan Drug and Advanced Therapy Medicinal Product, ATMP, designations to its lead asset, deramiocel, for the treatment of Duchenne muscular dystrophy, DMD. “Receiving the Orphan Drug and ATMP designations from the EMA are significant steps forward as we work to bring deramiocel to DMD patients worldwide,” said Linda Marban, Ph.D., Chief Executive Officer of Capricor. “With these designations from the EMA, along with Orphan Drug and RMAT designations from the U.S Food and Drug Administration, we have the opportunity to secure market exclusivity for deramiocel in two of the world’s key markets. These milestones reflect our commitment to advancing novel, transformative treatments for patients suffering from DMD.”