FDA Chooses Abeona's Gene Therapy for Rare Disease Pilot Program

Abeona Therapeutics Inc.s ABO-503 gene therapy for X-linked retinoschisis has been chosen by the Food and Drug Administration for a pilot program aimed at enhancing rare disease therapies.

• The Food and Drug Administration selected Abeonas ABO-503 gene therapy to participate in its Rare Disease Endpoint Advancement Pilot Program to improve treatment for X-linked retinoschisis.
• This gene therapy targets the retina and aims to address challenges in efficacy measurement for rare diseases, particularly those related to sex linkage in genetic disorders.
• Through the FDA program, Abeona Therapeutics will benefit from enhanced communication and regular consultations to expedite the clinical trial process for its biopharmaceutical product.