NEW YORK, December 5, 2020 / PRNewswire / – Pomerantz LLP announces that a class action lawsuit has been filed against Mesoblast Limited (“Mesoblast” or the “Company”) (NASDAQ: MESO) and certain of its officers. The class action, filed in United States District Court of the Southern District of New York, and listed under 20-cv-09111, is in the name of a class made up of all persons other than Defendants who have purchased or otherwise acquired Mesoblast securities between April 16, 2019 and October 1, 2020, inclusive (the “Class Period”). The plaintiff is pursuing claims against the defendants under the Securities Exchange Act of 1934 (the “Exchange Act”).
If you are a shareholder who purchased Mesoblast securities during the recourse period, you have until December 7, 2020, to ask the Court to appoint you as the principal 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. 7980. Those inquiring by email are encouraged to include their mailing address, phone number, and number of shares purchased.
[Click here for information about joining the class action]
Mesoblast develops allogeneic cellular drugs using its proprietary mesenchymal lineage cell therapy platform. Its lead product candidate, RYONCIL (remestemcel-L), is an investigational therapy comprising mesenchymal stem cells derived from bone marrow. In February 2018, the company announced that remestemcel-L met its primary endpoint in a phase 3 trial to treat children with acute graft-versus-host disease (“aGVHD”) refractory to steroids.
In early 2020, Mesoblast completed its continued submission of its Biologics License Application (“BLA”) to the United States Food and Drug Administration (“FDA”) for Marketing Authorization to market remestemcel -L for children with steroid refractory aGVHD.
The complaint alleges that throughout the period of the action, the defendants made materially false and misleading statements regarding the company’s business, operational and compliance policies. Specifically, the defendants have made false and / or misleading claims and / or failed to disclose that: (i) comparative analyzes between the Phase 3 trial of Mesoblast and three historical studies did not support efficacy remestemcel-L for steroid-refractory aGVHD due to design differences between the four studies; (ii) accordingly, the FDA was reasonably likely to require further clinical studies; iii) therefore, the commercialization of remestemcel-L in the United States would likely be delayed; and (iv) as a result of the foregoing, the positive statements of the defendants regarding the business, operations and prospects of the company were substantially misleading and / or lacked reasonable basis.
Sure Aug 11, 2020, the FDA released backgrounders for its Oncology Drugs Advisory Committee (“ODAC”) meeting to be held on Aug 13, 2020. There, the FDA said that Mesoblast provided post hoc analyzes of other studies “to further establish the relevance of 45% as a null day-28 ORR” for its primary endpoint. The background papers indicated that due to design differences between these historical studies and the study submitted by Mesoblast, “it is not clear that these study results are relevant to the proposed indication.”
At this news, the company’s American Depositary Share (“ADS”) price fell. $ 6.09 per share, or around 35%, to close at $ 11.33 per share on Aug 11, 2020, on an unusually high volume of transactions.
Sure October 1, 2020, Mesoblast disclosed that it had received a Complete Letter of Response (“CRL”) from the FDA regarding its marketing application for remestemcel-L for the treatment of SR-aGVHD in pediatric patients. According to CRL, the FDA recommended that the company “conduct at least one additional randomized controlled study in adults and / or children to provide further evidence of the efficacy of remestemcel-L for SR-aGVHD.” The CRL also “identified the need for further scientific justification to demonstrate the relationship between potency measurements and the biological activity of the product.”
At this news, the company’s ADS price has dropped $ 6.56 per share, or more than 35%, to close at $ 12.03 per share on October 2, 2020, on an unusually high volume of transactions.
The Pomerantz firm, with offices in New York, Chicago, Los Angeles, and Paris is recognized as one of the leading firms in the areas of corporate, securities and antitrust litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz law firm was the pioneer of class actions in securities. Today, more than 80 years later, Pomerantz continues the tradition it established, fighting for the rights of victims of securities fraud, breach of fiduciary duty and professional misconduct. The firm has recovered numerous indemnities of several million dollars on behalf of the members of the group. See www.pomerantzlaw.com.
Robert S. Willoughby
888-476-6529 ext. 7980
SOURCE Pomerantz LLP