SAN DIEGO–(BUSINESS WIRE)–Robbins Geller Rudman & Dowd LLP announces that a class action lawsuit has been filed in the Southern District of New York on behalf of purchasers or acquirers of Mesoblast Limited (NASDAQ:MESO) securities between April 16, 2019 and October 1, 2020, inclusive (the “Class Period”). The case is captioned Kristal v. Mesoblast Limited, No. 20-cv-08430, and is assigned to Judge Philip M. Halpern. The Mesoblast class action lawsuit charges Mesoblast and certain of its executives with violations of the Securities Exchange Act of 1934.
The Private Securities Litigation Reform Act of 1995 permits any investor who purchased Mesoblast securities during the Class Period to seek appointment as lead plaintiff in the Mesoblast class action lawsuit. A lead plaintiff will act on behalf of all other class members in directing the Mesoblast class action lawsuit. The lead plaintiff can select a law firm of its choice to litigate the Mesoblast class action lawsuit. An investor’s ability to share in any potential future recovery of the Mesoblast class action lawsuit is not dependent upon serving as lead plaintiff. If you wish to serve as lead plaintiff of the Mesoblast class action lawsuit or have questions concerning your rights regarding the Mesoblast class action lawsuit, please provide your information here or contact counsel, J.C. Sanchez of Robbins Geller, at 800/449-4900 or 619/231-1058 or via e-mail at email@example.com. Lead plaintiff motions for the Mesoblast class action lawsuit must be filed with the court no later than December 7, 2020.
Mesoblast develops allogeneic cellular medicines using its mesenchymal lineage cell therapy platform. Mesoblast’s lead product candidate, RYONCIL (remestemcel-L), is an investigational therapy comprising mesenchymal stem cells derived from bone marrow. In February 2018, Mesoblast announced that remestemcel-L met its primary endpoint in a Phase 3 trial to treat children with steroid refractory acute graft versus host disease (“SR-aGVHD”). In early 2020, Mesoblast completed its rolling submission of its Biologics License Application with the U.S. Food and Drug Administration (“FDA”) to secure marketing authorization to commercialize remestemcel-L for children with SR-aGVHD.
The Mesoblast class action lawsuit alleges that during the Class Period defendants made false and/or misleading statements and/or failed to disclose that: (1) comparative analyses between Mesoblast’s Phase 3 trial and three historical studies did not support the effectiveness of remestemcel-L for SR-aGVHD due to design differences between the four studies; (2) thus, the FDA was reasonably likely to require Mesoblast to conduct further clinical studies; (3) as such, Mesoblast’s commercialization of remestemcel-L in the United States was likely to be delayed; and (4) as a result of the foregoing, defendants’ positive statements about Mesoblast’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 meeting revealing that Mesoblast provided post hoc analyses of other studies “to further establish the appropriateness of 45% as the null Day-28” overall response rate for its primary endpoint. The briefing materials further stated that, due to 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, Mesoblast’s share price fell by nearly 35%.
Then, 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 Mesoblast “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, Mesoblast’s share price fell an additional 35%, further damaging investors.
Robbins Geller Rudman & Dowd LLP is one of the world’s leading law firms representing investors in securities class action litigation. With 200 lawyers in 9 offices, Robbins Geller has obtained many of the largest securities class action recoveries in history. For seven consecutive years, ISS Securities Class Action Services has ranked the Firm in its annual SCAS Top 50 Report as one of the top law firms in the world in both amount recovered for shareholders and total number of class action settlements. Robbins Geller attorneys have helped shape the securities laws and have recovered tens of billions of dollars on behalf of aggrieved victims. Beyond securing financial recoveries for defrauded investors, Robbins Geller also specializes in implementing corporate governance reforms, helping to improve the financial markets for investors worldwide. Robbins Geller attorneys are consistently recognized by courts, professional organizations, and the media as leading lawyers in the industry. Please visit http://www.rgrdlaw.com for more information.