Abeona Therapeutics® Announces ABO-503 Gene Therapy for X-linked Retinoschisis (XLRS) Selected by FDA for Rare Disease Endpoint Advancement (RDEA) Pilot Program
Abeona Therapeutics Inc. (ABEO)
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Source: GlobeNewswire
CLEVELAND, Oct. 13, 2025 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a commercial-stage biopharmaceutical company developing cell and gene therapies for serious diseases, today announced that its ABO-503 gene therapy for X-linked retinoschisis (XLRS) has been selected to participate in the U.S. Food and Drug Administration (FDA) Rare Disease Endpoint Advancement (RDEA) Pilot Program. The RDEA program facilitates the development and timely approval of rare disease therapies by supporting the use of novel efficacy endpoints in clinical trials. As part of the RDEA program, Abeona will have opportunities for enhanced communication and collaboration with the FDA, including frequent advice and regular ad-hoc conversations to accelerate the development and validation of product-specific novel efficacy endpoints for Abeona’s XLRS program. “XLRS is an underserved area with a large unmet need,” said Vish Seshadri, Chief Executive Officer of Abeona. “We are honored that ABO-5
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- 10/13/25 - HC Wainwright
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- 11/14/25 - Form 4
- 11/13/25 - Form SCHEDULE
- 11/12/25 - Form 10-Q
- ABEO's page on the SEC website