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Abeona Receives FDA Regenerative Medicine Advanced Therapy Designation
Jan. 29, 2018 09:34AM 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 that the US Food and Drug Administration has granted the Regenerative Medicine Advanced Therapy designation to EB-101, the Company’s gene-corrected autologous cell therapy product for patients with recessive dystrophic epidermolysis bullosa. As quoted …
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 that the US Food and Drug Administration has granted the Regenerative Medicine Advanced Therapy designation to EB-101, the Company’s gene-corrected autologous cell therapy product for patients with recessive dystrophic epidermolysis bullosa.
As quoted in the press release:
“EB-101 is an autologous gene-corrected cell therapy approach that utilizes a patient’s own cells and genetically re-engineers them to produce the missing collagen protein, which helps hold skin on to the body. This reduces the number of painful blisters caused by injury and has demonstrated improved wound healing in our Phase 1/2 clinical trial for over 2 years,” said Timothy J. Miller, Ph.D., President and CEO of Abeona.
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