NEW YORK, Nov. 18, 2019 /CNW/ -- Pomerantz LLP announces that a class action lawsuit has been filed against Abeona Therapeutics Inc. ("Abeona" or the "Company") (NASDAQ: ABEO) and certain of its officers. The class action, filed in United States District Court, for the Southern District of New York, and docketed under 19-cv-10181, is on behalf of a class consisting of investors who purchased or otherwise acquired Abeona securities between May 31, 2018 and September 23, 2019, both dates inclusive (the "Class Period"), seeking to recover damages caused by Defendants' violations of the federal securities laws and to pursue remedies under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the "Exchange Act") and Rule 10b-5 promulgated thereunder, against the Company and certain of its top officials.
If you are a shareholder who purchased Abeona between May 31, 2018 and September 23, 2019 the class period, you have until January 2, 2020, to ask the Court to appoint you as Lead Plaintiff for the class. A copy of the Complaint can be obtained at www.pomerantzlaw.com. To discuss this action, contact Robert S. Willoughby at [email protected] or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext. 9980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and number of shares purchased.
Abeona is a clinical-stage biopharmaceutical company that purports to develop cell and gene therapies for life-threatening rare genetic diseases.
Abeona's lead programs include, among other product candidates, EB-101 for the treatment of recessive dystrophic epidermolysis bullosa ("RDEB"). EB-101 is an autologous, gene-corrected cell therapy in which the normal COL7A1 gene is inserted into a patient's own skin cells (keratinocytes) and transplanted back to the patient to restore normal Type VII collagen expression and skin function. 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 (Phase I/II gene transfer for recessive dystrophic epidermolysis bullosa (NCT01263379)) 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. The Phase I/II study purportedly showed significant and durable healing of large chronic wounds, with up to five years of follow-up, with no reported serious adverse events observed. Continuous Type VII collagen expression was purportedly observed for more than two years post treatment, with no detection of replication competent retrovirus ("RCR") up to four years.
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. The primary endpoint of the study would be the proportion of EB-101 treated wounds with >50% healing at three months, compared with untreated wound site on the same patient. Secondary endpoints would include patient reported outcomes such as pain and itch and investigator global assessment of wounds.
The Complaint 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: (i) Abeona's Chemical, Manufacturing and Controls ("CMC") and internal controls and procedures and/or compliance policies were inadequate; (ii) 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; (iii) 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 (iv) as a result, the Company's public statements were materially false and misleading at all relevant times.
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"). 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.
On this news, Abeona's stock price fell $0.39 per share, or 11.96%, to close at $2.87 per share on September 23, 2019.
The Pomerantz Firm, with offices in New York, Chicago, Florida, and Los Angeles, 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, the Pomerantz Firm pioneered the field of securities class actions. Today, more than 80 years later, the Pomerantz Firm 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 numerous multimillion-dollar damages awards on behalf of class members. See www.pomerantzlaw.com
Robert S. Willoughby
SOURCE Pomerantz LLP