Kadmon Holdings, Inc.

  • Dismissed

Investigation
04/02/2021

Initial Lawsuit
04/02/2021

Lawsuit Progression
07/01/2021

Dismissal
07/22/2021

Investigation

  • Continous Holding
    October 1, 2020 to March 10, 2021
  • Proposed Claim
    Securities Violation

Investigation regarding Kadmon’s statements about the Belumosudil New Drug Application (NDA), the FDA information request and the information submitted resulting in an extension of the Prescription Drug User Fee Act (PDUFA) date.

Main Event

Extension of PDUFA Date

03/10/2021

SEC Filing

Kadmon announces that the FDA extended the review period for Belumosudil in chronic graft-versus-host disease:
“In a notice received from the FDA on March 9, 2021, the Company was informed that the Prescription Drug User Fee Act (PDUFA) goal date for its Priority Review of belumosudil has been extended to August 30, 2021.
The FDA extended the PDUFA date to allow time to review additional information submitted by Kadmon in response to a recent FDA information request. The submission of the additional information has been determined by the FDA to constitute a major amendment to the NDA, resulting in an extension of the PDUFA date by three months.“

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
$4.4 $4.92 $-0.52 -10.57%
See more on Factual Timeline

Initial Lawsuit

First Complaint - 04/02/2021
The complaint was voluntarily dismissed by the plaintiff without prejudice.
Contact an attorney to know more about the filing and dismissal of a complaint.

This is a federal securities class action on behalf of a class consisting of all persons and entities other than Defendants that purchased or otherwise acquired Kadmon securities between October 1, 2020 and March 10, 2021, both dates inclusive.

  • Filing Date
    04/02/2021
  • Class Period
    10/01/2020 to 03/10/2021
  • Transgression
    Securities Violation
  • Filing Firms
    Pomerantz LLP
  • Case Title
    Tadros v. Kadmon Holdings, Inc.
  • Docket Number
    2:21-cv-01797
  • Court
    New York Eastern District Court
  • Free File
    Complaint

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 that:

(i) the Belumosudil NDA was incomplete and/or deficient;
(ii) the additional new data that the Company submitted in support of the Belumosudil NDA in response to an information request from the FDA materially altered the NDA submission;
(iii) accordingly, the initial Belumosudil NDA submission lacked the degree of support that the Company had led investors to believe;
(iv) accordingly, the FDA was likely to extend the PDUFA target action date to review the Belumosudil NDA;
(v) as a result, the Company’s public statements were materially false and misleading at all relevanttimes.

Defendants

  • Company
    Kadmon
  • Chief Executive Officer
    Harlan W. Waksal
  • Chief Financial Officer
    Steven Meehan

Lawsuit progression

  • Docket Number
    2:21-cv-01797
  • Court
    New York Eastern District Court

Lead Counsel

07/01/2021

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

  • Lead Counsel
    Pomerantz LLP
  • Lead Plaintiff
    Individual

Dismissal

On 07/22/2021, plaintiff voluntarily dismissed the complaint.

Free File
Stipulation/Order of Dismissal

[stockdio-historical-chart symbol=”KDMN” stockExchange=”NYSENasdaq” width=”500″ height=”330″ motif=”blinds” palette=”humanity” includeVolume=false]

Factual Timeline

More

More Cases & Investigations
Privacy Policy
© Copyright 2024 Brios Services LLC
Terms & Conditions