NEW YORK, NY / ACCESSWIRE / June 9, 2024 / Pomerantz LLP is investigating claims on behalf of investors of Abeona Therapeutics Inc. ("Abeona" or the "Company") (NASDAQ:ABEO). Such investors are advised to contact Danielle Peyton at [email protected] or 646-581-9980, ext. 7980.
The investigation concerns whether Abeona and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
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On April 22, 2024, Abeona issued a press release "announc[ing] a regulatory update for prademagene zamikeracel (pz-cel)." Abeona's press release stated that "[t]he U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) in response to the Company's Biologics License Application (BLA) for pz-cel for the treatment of patients with recessive dystrophic epidermolysis bullosa (RDEB). The CRL follows the completion of Abeona's Late Cycle Review Meeting with the FDA in March 2024. At the Late Cycle Review Meeting and in a subsequent information request, the FDA noted that certain additional information needed to satisfy Chemistry Manufacturing and Controls (CMC) requirements must be satisfactorily resolved before the application can be approved. In response, the Company submitted plans to the FDA with the commitment to provide CMC data prior to BLA approval, and full validation reports after approval in mid-2024. In addition, the Company discussed these plans with the FDA in a subsequent informal meeting. In the CRL, the FDA indicated that the proposed timing of the data submission by Abeona would not allow sufficient time for the FDA to complete its review by the May 25, 2024 PDUFA date."
On this news, Abeona's stock price fell $3.95 per share, or 53.67%, to close at $3.41 per share on April 23, 2024.
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SOURCE: Pomerantz LLP