SAN DIEGO & NEW YORK--(BUSINESS WIRE)--Shareholder rights law firm Robbins LLP announces that a purchaser of Abeona Therapeutics Inc. (NASDAQ: ABEO) filed a class action complaint for alleged violations of the Securities Exchange Act of 1934 between May 31, 2018 and September 23, 2019. Abeona Therapeutics is a clinical-stage biopharmaceutical company that develops cell and gene therapies for life-threatening rare genetic diseases. Its lead programs include EB-101 for the treatment of recessive dystrophic epidermolysis bullosa ("RDEB").
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Abeona Therapeutics Inc. (ABEO) Receives Clinical Hold Letter from FDA
According to the complaint, in May 2018, Abeona announced the opening of a commercial Good Manufacturing Practice ("GMP") gene and cell therapy manufacturing facility in Ohio, touting its capacity to manufacture EB-101 and its ability to "satisfy the necessary chemistry, manufacturing, and controls (CMC) requirements for commercial development." Following this opening, in March 2019, Abeona reported in its Form 10-K that "[t]he Company expect[ed] to initiate [the VITAL Study]… in the middle of 2019" and highlighted Abeona's investments in its manufacturing processes. In May 2019, Abeona continued to tout the progress of the VITAL study evaluating EB-101 and the completion of its CMC work, reaffirming that the study was on track to start in mid-2019. Despite these assurances, on September 23, 2019, Abeona announced its receipt of a clinical hold letter from the FDA, revealing that it would not allow Phase 3 of the VITAL Study without the submission of additional data and the remediation of the Company's CMC issues. Since this news, Abeona's stock price has fallen almost 19% and currently trades at around $2.65.
Abeona Therapeutics Inc. (ABEO) Shareholders Have Legal Options
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