Abeona Therapeutics (ABEO) said Tuesday the US Food and Drug Administration has approved Zevaskyn, Abeona's prademagne zamikeracel gene-modified cellular sheets for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa.
Recessive dystrophic epidermolysis bullosa is a serious genetic skin condition with no cure, the company said.
Zevaskyn is expected to be available to patients through qualified treatment centers starting in Q3, Abeona said. In addition, the FDA granted a rare pediatric disease priority review voucher in connection with the approval of Zevaskyn, Abeona said, which the company plans to monetize.
Shares of the company were down more than 4% in recent Tuesday trading.
Price: 5.12, Change: -0.23, Percent Change: -4.30
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