NEW YORK, May 30, 2024 /PRNewswire/ -- 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 newaction@pomlaw.com 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.
Pomerantz LLP, with offices in New York, Chicago, Los Angeles, London, Paris, and Tel Aviv, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions. Today, more than 85 years later, Pomerantz continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered billions of dollars in damages awards on behalf of class members. See www.pomlaw.com.
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CONTACT:
Danielle Peyton
Pomerantz LLP
dpeyton@pomlaw.com
646-581-9980 ext. 7980
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SOURCE Pomerantz LLP
