Abeona Therapeutics (NASDAQ:ABEO) reports that the FDA has placed a clinical hold on its planned Phase 3 clinical trial evaluating autologous cell therapy EB-101 in patients with recessive dystrophic epidermolysis bullosa until it receives and reviews additional data on EB-101’s transport stability to clinical trial sites. The company intends to resolve the issue as soon as feasible and maintains its expectation of FDA sign-off on the trial in Q4.
The stock sold off in November 2018 after the company announced a delay in the start of the study.
Shares, currently halted, will resume trading at 9:15 am ET.
Management hosted a conference call this morning at 9:30 am ET to discuss the matter.
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