Lawsuit filed for Investors in shares of Mesoblast Limited (OTC: MEOBF) over alleged Securities Laws Violations

An investor, who purchased shares of Mesoblast Limited (OTC: MEOBF), filed a lawsuit in the U.S. over alleged violations of Federal Securities Laws by Mesoblast Limited.

Investors who purchased shares of Mesoblast Limited (OTC: MEOBF) have certain options and for certain investors are short and strict deadlines running. Deadline: December 7, 2020. OTC: MEOBF investors should contact the Shareholders Foundation at mail@shareholdersfoundation.com or call +1(858) 779 - 1554.

Australia based Mesoblast Limited, a biopharmaceutical company, develops and commercializes allogeneic cellular medicines. In early 2020, Mesoblast Limited 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.

On August 11, 2020, the FDA released briefing materials for the August 13, 2020 meeting of the FDA's Oncologic Drugs Advisory Committee, at which the FDA will review and discuss Mesoblast's marketing application for Ryoncil (remestemcel-L) for the treatment of steroid-refractory acute graft-versus-host disease in pediatric patients. The FDA briefing documents stated that it is "unclear" whether the study results supporting Mesoblast's application are "relevant" to the proposed indication for use.

On October 1, 2020, Mesoblast Limited 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."

The plaintiff claims that between April 16, 2019 and October 1, 2020, the Defendants failed to disclose to investors, that comparative analyses between Mesoblast’s Phase 3 trial and three historical studies did not support the effectiveness of remestemcel-L for steroid refractory aGVHD due to design differences between the four studies, that, as a result, the FDA was reasonably likely to require further clinical studies, that, as a result, the commercialization of remestemcel-L in the U.S. was likely to be delayed, and that, 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.

Those who purchased shares of Mesoblast Limited (OTC: MEOBF) have certain options and should contact the Shareholders Foundation.

Media Contact:
Michael Daniels
Shareholders Foundation, Inc.
3111 Camino Del Rio North
Suite 423
San Diego, CA 92108
Tel: +1-(858)-779-1554
E-Mail: mail@shareholdersfoundation.com

About Shareholders Foundation, Inc.
The Shareholders Foundation, Inc. is a professional portfolio monitoring and settlement claim filing service, and an investor advocacy group, which does research related to shareholder issues and informs investors of securities class actions, settlements, judgments, and other legal related news to the stock/financial market. Shareholders Foundation, Inc. is in contact with a large number of shareholders and offers help, support, and assistance for every shareholder. The Shareholders Foundation, Inc. is not a law firm. Referenced cases, investigations, and/or settlements are not filed/initiated/reached and/or are not related to Shareholders Foundation. The information is provided as a public service. It is not intended as legal advice and should not be relied upon.

This release was published on openPR.