Vericel Corporation (VCEL)
Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of Vericel Corporation ("Vericel" or "the Company") (NASDAQ: VCEL). The investigation concerns whether Vericel and certain of its officers and/or directors have violated federal securities laws.
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 sharply during intraday trading on June 29, 2021.
If you are aware of any facts relating to this investigation, or purchased Vericel shares, you can assist this investigation. You can also contact Peretz Bronstein or his Investor Relations Analyst, Yael Hurwitz of Bronstein, Gewirtz & Grossman, LLC: 212-697-6484.
Bronstein, Gewirtz & Grossman, LLC is a corporate litigation boutique. Our primary expertise is the aggressive pursuit of litigation claims on behalf of our clients. In addition to representing institutions and other investor plaintiffs in class action security litigation, the firm’s expertise includes general corporate and commercial litigation, as well as securities arbitration. Attorney advertising. Prior results do not guarantee similar outcomes.