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NRx Pharmaceuticals, Inc.

Class Action
  • Active
Investigation
11/05/2021
Initial Lawsuit
01/18/2022
Lawsuit Progression
04/06/2022

Investigation

Investigation in connection with NRx’s statements made in connection with its application filed with the FDA requesting Emergency Use Authorization (EUA) for ZYESAMI (Aviptadil-acetate) to treat critically ill COVID-19 patients suffering with respiratory failure.

  • Investigation Date
    11/05/2021
  • Hypothetical Affected Period
    June 1, 2021 to November 4, 2021
  • Hypothetical Transgression
    Securities Violation
Main Event

EUA Declined

11/04/2021

News Outlets

NRx Pharmaceuticals announces that the US Food and Drug Administration (FDA) has declined to issue an Emergency Use Authorization (EUA) for ZYESAMI (aviptadil). The FDA stated that it was unable to issue the EUA “due to insufficient data regarding the known and potential benefits of the medicine and the known and potential risks of ZYESAMI in patients suffering from Critical COVID-19 with respiratory failure.” The FDA noted that it had reviewed safety in only 131 randomized patients treated with ZYESAMI.

“NRx will attempt to coordinate a review by the FDA of the 150 or more additional patients already treated with ZYESAMI in the NIH ACTIV-3b trial. Last week, the study’s Data Safety and Monitoring Board reviewed the ongoing NIH ACTIV-3b trial and found no new safety issues.”

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
$6.65 $8.92 $-2.27 -25.45%
See more on Factual Timeline

Initial Lawsuit

First Complaint - 01/18/2022

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 NRx securities between June 1, 2021 and November 4, 2021, both dates inclusive.

  • Filing Date
    01/18/2022
  • Class Period
    06/01/2021 to 11/04/2021
  • Transgression
    Securities Violation
  • Filing Firms
    Pomerantz LLP
    Bielli & Klauder, LLC
  • Case Title
    Dal Bosco v. NRx Pharmaceuticals, Inc. et al
  • Docket Number
    1:22-cv-00066
  • Court
    Delaware 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 application with [the] U.S. Food and Drug Administration requesting Emergency Use Authorization (EUA) for ZYESAMI (Aviptadil-acetate) to treat critically ill COVID-19 patients suffering with respiratory failure contained insufficient data regarding the potential benefits and risks of ZYESAMI;
(ii) accordingly, the FDA was unlikely to approve the ZYESAMI EUA application in its present form; and
(iii) as a result, the company’s public statements were materially false and misleading at all relevant times.

Defendants

  • Company
    NRx Pharmaceuticals, Inc.
  • Chief Executive Officer
    Jonathan C. Javitt
  • Chief Financial Officer
    William Fricker

Lawsuit progression

  • Docket Number
    1:22-cv-00066
  • Court
    Delaware District Court

Lead Counsel

04/06/2022

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

Factual Timeline

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