By Chris Wack


Abeona Therapeutics shares were down 13% to $7.50 after the company said the U.S. Food and Drug Administration has completed a pre-license inspection of its Cleveland, Ohio, manufacturing facility.

The stock hit its 52-week high of $9.01 on March 6, and is up 208% in the past 12 months.

The company said the inspection was in relation to its Biologics License Application for pz-cel, or prademagene zamikeracel, for recessive dystrophic epidermolysis bullosa.

During the inspection, the FDA reviewed the facilities, systems, and processes at the Cleveland site. The FDA also observed the manufacturing process for pz-cel, as well as performance of in-process and release assays.

The two-week inspection ended March 1. Upon completion of the inspection, a Form 483 was issued with observations related to process controls.

On Friday, the company submitted a response to the FDA, outlining already implemented and ongoing steps toward resolution that follow FDA guidance provided during the audit. The FDA's review of Abeona's pz-cel BLA is ongoing, with a target Prescription Drug User Fee Act date of May 25. The FDA doesn't currently plan to conduct an Advisory Committee.


Write to Chris Wack at chris.wack@wsj.com


(END) Dow Jones Newswires

03-18-24 1039ET