Abeona Therapeutics Receives FDA Breakthrough Therapy Designation

Abeona Therapeutics (NASDAQ:ABEO) announced the US Food and Drug Administration granted a Breakthrough Therapy designation status to the company’s EB-101 gene therapy program.
As quoted in the press release:

The designation from the FDA enables collaborative discussions with senior FDA personnel, priority review and an expedited approval process to drug candidates where preliminary clinical trials indicate that a therapy may offer substantial treatment advantages over existing options for patients with serious or life-threatening diseases.

“EB-101 is an autologous gene-corrected cell therapeutic approach that utilizes a patient’s own cells and genetically engineering them to produce the correct version of collagen, which helps hold skin on to the body, thereby reducing the number of painful blisters caused by injury and improving wound healing,” stated Timothy J. Miller, Ph.D., Abeona’s President and CEO.

Click here to read the full press release.

Source: globenewswire.com