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Abeona's cell therapy placed on clinical hold by US FDA for transport concerns

The U.S. Food and Drug Administration placed a clinical hold on Abeona Therapeutics Inc.'s cell therapy dubbed EB-101 ahead of a planned phase 3 clinical trial.

Abeona said in a Sept. 23 release that the regulator requested more data on the treatment's stability as it is transported to clinical sites.

The cell therapy is intended to treat a rare connective tissue disorder called recessive dystrophic epidermolysis bullosa. Cell therapy involves removing certain cells from a patient, genetically engineering those cells outside the body and then replacing them in the patient.

During a Sept. 23 call, Abeona CEO João Siffert said the farthest the living tissue would need to travel is from Cleveland to Palo Alto, Calif., a journey the company has completed multiple times. He said the FDA requires more data points to confirm that the stability of the tissue is adequate.

Despite the clinical hold, the company still expects to receive clearance for a phase 3 trial called Viital in the fourth quarter.

"Initiating the Viital pivotal phase 3 trial for EB-101 is the company's top priority," Siffert said during the call. "Efforts to gather supplemental data points on transport stability of EB-101 are ongoing and we are confident that the requested additional data will be submitted to the FDA promptly."

Shares of Abeona were down 12.42% to $2.86 each as of 12:25 p.m. ET Sept. 23.

Abeona's EB-101 received the FDA's regenerative medicine advanced therapy designation in January 2018, a status granted to regenerative therapies with the potential to treat a serious or life-threatening disease with unmet medical needs.