Investigation Overview
An investigation on behalf of investors of Mesoblast Limited (OTC: MEOBF) shares over potential securities laws violations by Mesoblast Limited and certain of its directors and officers in connection with certain financial statements was announced.
The investigation by a law firm focuses on possible claims on behalf of purchasers of the securities of Mesoblast Limited (OTC: MEOBF) concerning whether a series of statements by Mesoblast Limited regarding its business, its prospects and its operations were materially false and misleading at the time they were made.
Australia based Mesoblast Limited, a biopharmaceutical company, develops and commercializes allogeneic cellular medicines. Mesoblast Limited reported that its Total Revenue declined from 16.97 million for the 12 months period that ended on June 30, 2018, to 16 million for the 12 months period that ended on June 30, 2019, and that its Net Loss over those respective time periods increased from 35.29 million to 89.79 million.
On August 11, 2020, the U.S. Food and Drug Administration ('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.