NEW YORK, July 18, 2021 /PRNewswire/ — Pomerantz LLP is investigating claims on behalf of investors of Vericel Corporation («Vericel» or the «Company») (NASDAQ: VCEL). Such investors are advised to contact Robert S. Willoughby at email@example.com or 888-476-6529, ext. 7980.
The investigation concerns whether Vericel and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
On May 7, 2019, Vericel announced entry into an exclusive license agreement with MediWound Ltd. («MediWound») to commercialize NexoBrid, a product under development by MediWound for debridement of severe thermal burns, in North America.
Then, on June 29, 2021, MediWound issued a press release «announc[ing] it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) seeking approval of NexoBrid® for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns.» MediWound disclosed that following completion of its review of the BLA, the FDA «determined that the application cannot be approved in its present form. The FDA identified issues related to the Chemistry, Manufacturing and Controls (‘CMC’) section of the BLA and requested additional CMC information.» MediWound further disclosed that «[t]he FDA also stated that an inspection of NexoBrid’s manufacturing facilities in Israel and Taiwan, are required before the FDA can approve the BLA, but it was unable to conduct the required inspections during the current review cycle due to COVID-related travel restrictions. The FDA stated that it will continue to monitor the public health situation as well as travel restrictions and is actively working to define an approach for scheduling outstanding inspections. In addition, the CRL cited certain observations identified during good clinical practice (GCP) inspections related to the U.S. Phase 3 study (DETECT), and requested the company to provide its perspective on the potential impact, if any, of these observations on the efficacy findings in the study»
On this news, Vericel’s stock price fell $10.04, or 14.81% to close at $57.77 on June 29, 2021.
The Pomerantz Firm, with offices in New York, Chicago, Los Angeles, and Paris 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
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SOURCE Pomerantz LLP