Investigation regarding statements made by Mesoblast on RYONCIL, the interaction between the trials and studies conducted to prove its efficacy and the outcome of private communications with the FDA about the BLA in its current form. Recent documents released by the FDA prior to the Oncologic Drug Advisory Committee (ODAC) meeting’s session on issues related to the proposed use of RYONCIL for the treatment of steroid-refractory acute graft-versus-hose disease in pediatric patients have caused Mesoblast’s stock to dramatically decrease in value: morning and afternoon sessions regarding product characterization and clinical evidence.
Mesoblast discloses the receipt of Complete Response Letter (CRL) from the FDA regarding its BLA for its allogeneic cellular medicine remestemcel-L in children with steroid-refractory acute Graft Versus Host Disease (SR-aGVHD). In the letter, the FDA declined approval of the application in its current form and recommended that Mesoblast conducts at least one randomized controlled study to provide further evidence of the effectiveness of RYONCIL.
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Plaintiff brings this securities class action on behalf of persons and entities that purchased or otherwise acquired Mesoblast securities between April 16, 2019 and October 1, 2020, inclusive.
According to the complaint, defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the company’s business, operations, and prospects. Specifically, defendants allegedly failed to disclose to investors:
(1) 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;
(2) that, as a result, the FDA was reasonably likely to require further clinical studies;
(3) that, as a result, the commercialization of remestemcel-L in the U.S. was likely to be delayed; and
(4) 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.
The court issued an order appointing the lead plaintiff and lead counsel.
Lead plaintiff brings this securities class action on behalf of all persons or entities who purchased Mesoblast publicly traded American Depository Shares (ADS) on the NASDAQ between December 13, 2018 and October 2, 2020, inclusive and who held such shares on August 11, 2020, and/or October 2, 2020
On 03/28/2022, lead counsel The Rosen Law Firm, P.A. announced a proposed class action settlement.
The court preliminarily approved the settlement on 04/08/2022. The settlement has a total value of $2,000,000 in Cash.
The notice states that you may be included, if you purchased or otherwise acquired the company’s publicly traded common stock during the period from 12/13/2018 to 10/02/2020, inclusive.
According to the notice, the estimated average cash recovery per damaged share of common stock will be approximately $0.15 per share, before deduction of court-approved fees and expenses. Lead Counsel filed a motion for an award of attorneys’ fees not to exceed 33.3% of the $2,000,000 and payment of expenses not to exceed $50,000.
For information purposes only, last updated on 05/10/2022. Contact the claims administrator or lead counsel for further information.
A securities class action lawsuit is a lawsuit on behalf of investors considered in a similar position, who purchased or sold securities of a company during a certain period and suffered losses because of an alleged wrongdoing. Security is often broadly defined to include bonds, stocks, options, derivatives, and other instruments.
Section 10b of the Securities Exchange Act of 1934 makes it unlawful to “use or employ, in connection with the purchase or sale of any security” a “manipulative or deceptive device or contrivance in contravention of such rules and regulations as the [SEC] may prescribe.” 15 U.S.C. § 78j(b). It is therefore forbidden to: employ any device, scheme, or artifice to defraud; make any untrue statement of a material fact or to omit to state a material fact necessary in order to make the statements made not misleading; or engage in any act, practice, or course of business which operates or would operate as a fraud or deceit upon any person.
Generally, to be successful, the plaintiff must plead the following:
We invite you to read this article from the American Bar Association which, although from 2014, provide ample information to explore the world of class actions brought under section 10b of Securities Exchange Act of 1934.
Section 11 of the Securities Act of 1933 provides “an express right of action for damages . . . when a registration statement contains untrue statements of material fact or omissions of material fact.” (Thomas Lee Hazen, Treatise on the Law of Securities Regulation, §7.3 at 581 (4th ed. 2002)). Practically, buyers in an initial public offering (IPO), relying on the registration statement and prospectus, are given the right to file a complaint against the company and other signatories for losses sustained as a result of the deficient registration statement and prospectus.
Generally, at least four elements must be plead for the claim to survive:
A shareholder derivative lawsuit is a lawsuit brought by a shareholder of a company, on behalf of the company, against an insider (director, board of directors, executives) or a third-party to redress wrongs and harms to the company. Simply speaking, this mechanism exists because one cannot expect directors and insiders to sue themselves for harms they have done to the company.
The Private Securities Litigation Reform Act (PSLRA) of 1995 was enacted to tighten requirements for securities class actions to be brought in the United States. One of the mechanism put in place was a 60-day period, following the filing of the initial securities class action, for any shareholder considered in similar position to the one filing the initial class action complaint, to ask to be named lead plaintiff. Practically, any time a securities class action falling under the PSLRA is filed with a court, law firms advertise their willingness to pursue the case and invite other investors similarly situated to contact them.
The lead plaintiff in a securities class action is a shareholder who suffered losses related to the purchase or sale of a company’s security during a certain period of time, that is appointed with its choice of counsel to represent the rest of the similarly situated shareholders. To be appointed lead plaintiff, you need to contact a law firm, have them examine your losses and agree to be represented by them and ask to make a motion with the court to be appointed lead. The court will then look at all the motions from the different shareholders and make its decision based on a certain set of criteria. Your inability to be lead plaintiff shall not prevent you from any potential recovery in the event of a settlement.
A class period is a set period of time during which the purchasers or sellers of a company’s security claim in a class action lawsuit to have suffered losses. Class periods are based on the merits of the case and may evolve with the litigation.
A class action complaint will define the initial class of investors: the class period and the persons included in the class. You should look at the definition of the class to determine whether you are included or not. However, the class definition will evolve with the litigation. Its definition is very likely to change between the initial complaint filed and the possible settlement. Generally speaking, you should rely on the definitions of the class stated in a stipulation of settlement to determine whether or not you will be entitled to any recovery (see below about the opting-out mechanism).
You may. The mechanism is called opting-out of class. A lead plaintiff will agree on the potential recovery ratio in a settlement. You may have an interest in opting-out of a class if you have sustained large losses and believe bringing a separate lawsuit would entitle you to a larger ratio of recovery.
You may be able to bring a claim to arbitration in certain scenarios. We encourage you to contact a law firm of your choice to inquire about such alternative dispute resolution mechanism.