Abeona Gets FDA Priority Review of Pz-cel in Connective-Tissue Disorder

By Colin Kellaher

Abeona Therapeutics has won U.S. Food and Drug Administration priority review for its application seeking approval of its pz-cel drug candidate for the treatment of patients with recessive dystrophic epidermolysis bullosa, a rare, inherited connective-tissue disorder.

The Cleveland clinical-stage biopharmaceutical company on Monday said the FDA has set a target action date of May 25, 2024, for the application, adding that the agency doesn't currently plan to hold an advisory committee meeting.

The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, with the designation shortening the review period.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

11-27-23 0802ET