NEW YORK, Nov. 11, 2020 (GLOBE NEWSWIRE) — 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 for the Southern District of New York, and docketed under 20-cv-09111, is on behalf of a class consisting of all persons other than Defendants who purchased or otherwise, acquired Mesoblast securities between April 16, 2019 and October 1, 2020, inclusive (the “Class Period”). Plaintiff pursues 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 class period, you have until December 7, 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. 7980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased.
Mesoblast develops allogeneic cellular medicines 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 steroid refractory (“SR”) acute graft versus host disease (“aGVHD”).
In early 2020, Mesoblast completed its rolling submission of its Biologics License Application (“BLA”) with the U.S. Food and Drug Administration (“FDA”) to secure marketing authorization to commercialize remestemcel-L for children with steroid refractory aGVHD.
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) comparative analyses between Mesoblast’s Phase 3 trial and three historical studies did not support the effectiveness of remestemcel-L for steroid refractory aGVHD because of design differences between the four studies; (ii) as a result, the FDA was reasonably likely to require further clinical studies; (iii) as a result, the commercialization of remestemcel-L in the U.S. was likely to be delayed; and (iv) as a result of the foregoing, Defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis.
On August 11, 2020, the FDA released briefing materials for its Oncologic Drugs Advisory Committee (“ODAC”) meeting to be held on August 13, 2020. Therein, the FDA stated that Mesoblast provided post hoc analyses of other studies “to further establish the appropriateness of 45% as the null Day-28 ORR” for its primary endpoint. The briefing materials stated that, because of design differences between these historical studies and Mesoblast’s submitted study, “it is unclear that these study results are relevant to the proposed indication.”
On this news, the Company’s American Depositary Share (“ADS”) price fell $6.09 per share, or approximately 35%, to close at $11.33 per share on August 11, 2020, on unusually heavy trading volume.
On October 1, 2020, Mesoblast disclosed that it had received a Complete Response Letter (“CRL”) from the FDA regarding its marketing application for remestemcel-L for treatment of SR-aGVHD in pediatric patients. According to the 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 effectiveness of remestemcel-L for SR-aGVHD.” The CRL also “identified a need for further scientific rationale to demonstrate the relationship of potency measurements to the product’s biologic activity.”
On this news, the Company’s ADS price fell $6.56 per share, or over 35%, to close at $12.03 per share on October 2, 2020, on unusually heavy trading volume.
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
888-476-6529 ext. 7980