miRagen Therapeutics Receives Orphan-Drug Designation for MRG-106

miRagen Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on the discovery and development of microRNA-targeted therapies, today announced that the U.S. Food and Drug Administration (“FDA”) has granted orphan-drug designation to miRagen’s product candidate, MRG-106, for the treatment of mycosis fungoides. Mycosis fungoides is the most common form of a type of blood cancer called cutaneous T-cell lymphoma (“CTCL”). CTCL occurs when certain types of T-cells become cancerous and cause debilitating tumors in the skin and in other parts of the body.

Paul Rubin, M.D., miRagen’s Executive Vice President of Research and Development, said, “We see the FDA’s granting of orphan-drug designation for MRG-106 as underscoring the medical need for novel therapies in the treatment of mycosis fungoides, and we believe it should facilitate our ability to continue developing this product candidate for potential use in these patients.”

“This designation is an important step forward for our MRG-106 program as we continue to advance our clinical and regulatory strategy in areas of high unmet medical need,” added William S. Marshall, Ph.D., President and CEO of miRagen. “Patients suffering from mycosis fungoides have few treatment options available, and MRG-106 could be an alternative approach to battling the disease.”