Adverum Biotechnologies announces FDA RMAT designation for Ixo-vec

Adverum Biotechnologies announced that the U.S. Food and Drug Administration, FDA, has granted Regenerative Medicine Advanced Therapy, RMAT, designation for Ixo-vec, its clinical-stage gene therapy product candidate, for the treatment of wet AMD. “The RMAT designation is based on the clinical data from Ixo-vec to date and recognizes the transformative potential of our gene therapy for patients with wet AMD,” stated Laurent Fischer, M.D., president and chief executive officer of Adverum Biotechnologies. “This validates that Ixo-vec has the potential to address the significant unmet medical needs in treating nAMD. With both RMAT and PRIME designations, we look forward to continuing our close collaborations with both the FDA and EMA on our pivotal program and to sharing updates from regulatory discussions in the fourth quarter of this year.”