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Abeona Therapeutics Receives FDA Orphan Drug Designation for ABO-202 Gene Therapy Program
Feb. 13, 2018 09:48AM PST
Pharmaceutical InvestingAbeona Therapeutics (NASDAQ:ABEO), a leading clinical-stage biopharmaceutical company focused on developing novel cell and gene therapies for life-threatening rare genetic diseases, announced today that the FDA has granted Orphan Drug Designation (ODD) to its ABO-202 program (AAV-CLN1), an AAV-based gene therapy for the treatment of infantile Batten disease. As quoted in the press release: “This …
Abeona Therapeutics (NASDAQ:ABEO), a leading clinical-stage biopharmaceutical company focused on developing novel cell and gene therapies for life-threatening rare genetic diseases, announced today that the FDA has granted Orphan Drug Designation (ODD) to its ABO-202 program (AAV-CLN1), an AAV-based gene therapy for the treatment of infantile Batten disease.
As quoted in the press release:
“This designation builds on our clinical portfolio of AAV gene therapies that have received FDA and EMA orphan drug designations, which is an important validation of the scientific and clinical translation of these products for the severely underserved CLN1 patient population,” stated Timothy J. Miller, Ph.D., President & CEO of Abeona Therapeutics Inc.
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