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Mesoblast Limited

Class Action
  • Settled
Investigation
10/02/2020
Initial Lawsuit
10/08/2020
Lawsuit Progression
12/23/2020
Settlement
03/28/2022

Investigation

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.

  • Investigation Date
    10/02/2020
  • Hypothetical Affected Period
    April 16, 2019 to October 1, 2020
  • Hypothetical Transgression
    Securities Violation
Main Event

BLA Refused

10/01/2020

Company Statement

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.

The stock impact compares the closing price immediately preceding the date of the event and the following closing price. The price difference also reflects the overall mix of information.

Stock Impact

Close Previous close Price variation Percentage variation
$12.03 $18.59 $-6.56 -35.29%
See more on Factual Timeline

Initial Lawsuit

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.

Allegations

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.

Defendants

  • Company
    Mesoblast Limited
  • Chief Executive Officer
    Silviu Itescu
  • Chief Financial Officer
    Josh Muntner

Lawsuit progression

  • Docket Number
    7:20-cv-08430
  • Court
    New York Southern District Court

Lead Counsel

12/23/2020

The court issued an order appointing the lead plaintiff and lead counsel.

Amended Complaint

08/17/2021

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

  • Updated Class Period
    12/13/2018 to 10/02/2020
  • Free File
    Amended Complaint

    • Operative complaint

Settlement

Announce

On 03/28/2022, lead counsel The Rosen Law Firm, P.A. announced a proposed class action settlement.

Preliminary Approval

The court preliminarily approved the settlement on 04/08/2022. The settlement has a total value of $2,000,000 in Cash.

Am I included?

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.

What is the estimated recovery?

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.

How can I file a claim?

For information purposes only, last updated on 05/10/2022. Contact the claims administrator or lead counsel for further information.

Source

Factual Timeline

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