Editas Medicine granted FDA RMAT designation for EDIT-301

Editas Medicine announced that the U.S. Food and Drug Administration, FDA, granted Regenerative Medicine Advanced Therapy, RMAT, designation to EDIT-301, an investigational, gene editing medicine, for the treatment of severe sickle cell disease, SCD. “Sickle cell disease is a devastating disease that leads to anemia, pain crises, organ failure, and early death. Receiving RMAT designation for EDIT-301 for severe sickle cell disease highlights the urgent need for new treatment options for patients and supports our belief that EDIT-301 can provide life-changing clinical benefits to patients,” Gilmore O’Neill, M.B., M.M.Sc., President and Chief Executive Officer, Editas Medicine. “I would like to thank the participants, their families, clinicians, and colleagues at collaborating institutions that contribute to the RUBY trial. We look forward to sharing further clinical updates including additional data for the trial prior to year-end.”