10:34 AM EDT, 10/13/2025 (MT Newswires) -- Abeona Therapeutics ( ABEO ) said Monday its experimental gene therapy ABO-503 was accepted into the US Food and Drug Administration' Rare Disease Endpoint Advancement Pilot Program, which aims to speed up development of treatments for rare conditions.

ABO-503 targets X-linked retinoschisis, a genetic eye disease that affects retinal structure and function. The therapy uses Abeona's AIM AAV204 delivery system to insert a working RS1 gene and has shown promising results in preclinical studies.

The company expects to complete key studies needed to file for FDA approval in H2 2026.

Abeona shares fell 2.6% in recent Monday trading.

Price: 5.22, Change: -0.14, Percent Change: -2.61