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Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company committed to delivering a new class of RNA therapeutics called Antibody Oligonucleotide Conjugates (AOCs™), announced that the European Commission (EC) has granted orphan designation for AOC 1001. The U.S. Food and Drug administration also granted orphan drug designation to AOC 1001 earlier this summer.
The U.S. Food and Drug Administration (FDA) cleared Avidity to proceed with the Phase 1/2 MARINATM trial of AOC 1001 in adults with myotonic dystrophy type 1 (DM1) in the United States.
“We are pleased that both the EC and the FDA have granted AOC 1001 Orphan Designation, further validating AOCs as a powerful new class of drugs that can bring benefit to people suffering from untreated and undertreated diseases,” said Sarah Boyce, president and chief executive officer of Avidity. “AOC 1001 is designed to address the root cause of DM1 and has the potential to be a first-in-class treatment for people living with this debilitating rare disease.”
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