January 10, 2020 - The case was voluntarily dismissed.

November 1, 2019 - An investor in shares of Abeona Therapeutics Inc. (NASDAQ: ABEO) filed a lawsuit in the U.S. District Court for the Southern District of New York over alleged violations of Federal Securities Laws by Abeona Therapeutics Inc. in connection with certain allegedly false and misleading statements made between May 31, 2018 and September 23, 2019.

New York based Abeona Therapeutics Inc., a clinical-stage biopharmaceutical company, develops cell and gene therapies for life-threatening rare genetic diseases. Abeona Therapeutics Inc’s lead programs include, among other product candidates, EB-101 for the treatment of recessive dystrophic epidermolysis bullosa (“RDEB”). EB-101 is an autologous, gene-corrected cell therapy in which the normal COL7A1 gene is inserted into a patient’s own skin cells (keratinocytes) and transplanted back to the patient to restore normal Type VII collagen expression and skin function. From preliminary clinical data and expert input, Abeona Therapeutics Inc expected EB-101 to be a potential treatment choice for most wounds, and believes it is currently the only product candidate being evaluated as a treatment for larger wounds.

On September 23, 2019, Abeona Therapeutics Inc announced receipt of a clinical hold letter from the U.S. Food and Drug Administration (“FDA”), “clarifying that the FDA will not provide approval for the Company to begin its planned Phase 3 clinical trial for EB-101 until it submits to the FDA additional data points on transport stability of EB-101 to clinical sites.” Shares of Abeona Therapeutics Inc. (NASDAQ: ABEO) declined from $21.70 per share on April 2018 to as low as $2.07 per share on October 2, 2019.

According to the complaint the plaintiff alleges on behalf of purchasers of Abeona Therapeutics Inc. (NASDAQ: ABEO) common shares between May 31, 2018 and September 23, 2019, that the defendants violated Federal Securities Laws.

More specifically, the plaintiff claims that between May 31, 2018 and September 23, 2019, the defendants made false and/or misleading statements and/or failed to disclose that Abeona’s Chemical, Manufacturing and Controls (“CMC”) and internal controls and procedures and/or compliance policies were inadequate, that as a result, the Company failed to provide sufficient data points on the transport stability of EB-101 to clinical sites, or else such transport stability was insufficient, that consequently, it was foreseeable that the U.S. Food and Drug Administration (“FDA”) would reject approval for the start of the VITAL Study until such issues were addressed, and that as a result, the Company’s public statements were materially false and misleading at all relevant times.