Abeona Therapeutics Inc. (ABEO) Receives Clinical Hold Letter from FDA
According to the class action complaint for alleged violations of the Securities Exchange Act of 1934, 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 “he Company expect to initiate … 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.
