Bragar eagel & squire, p.c. announces class action lawsuit against abeona therapeutics, inc

Bragar eagel & squire, p.c. announced that a class action lawsuit has been filed in the united states district court for the southern district of new york on behalf of investors that purchased abeona therapeutics inc. securities between may 31, 2018 and september 23, 2019 (the “class period”). investors have until january 2, 2019 to apply to the court to be appointed as lead plaintiff in the lawsuit. from preliminary clinical data and expert input, the company 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. results from a completed phase i/ii study that enrolled seven patients with chronic rdeb wounds at stanford university purportedly showed that eb-101 was well-tolerated and resulted in significant and durable wound healing. abeona expected to initiate a pivotal clinical trial evaluating the potential of eb-101 for the treatment of rdeb in the middle of 2019. the so-called vital study would be a multicenter, randomized, phase iii clinical trial assessing ten to fifteen patients treated with eb-101. on september 23, 2019, abeona issued a press release announcing receipt of a clinical hold letter from the fda, “clarifying that the fda will not provide approval for the company to begin its planned phase 3 clinical trial for eb-101 [a/k/a, the vital study] until it submits to the fda additional data points on transport stability of eb-101 to clinical sites”. the september 2019 press release also disclosed that abeona had been working with the fda for at least a year to address issues with the company’s cmc. the complaint, filed on november 1, 2019, alleges that throughout the class period, defendants made materially false and misleading statements regarding the company’s business, operational and compliance policies. specifically, 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; 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; 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 as a result, the company’s public statements were materially false and misleading at all relevant times.
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