By Sam Boughedda
Investing.com — NRX Pharmaceuticals (NASDAQ:) shares surged Tuesday after it reported 2 new updates related to its treatment for Covid-19 respiratory failure.
The shares rallied 60.9% to $10.91 on Tuesday. However, they are still down 55.87% for the year to date.
The company said a revamped Investigational New Drug module on the manufacturing of Zyesami was proposed to the U.S. Food and Drug Administration (FDA), including documentation that confirmed Nephron Pharmaceuticals can supply the treatment on a commercial scale.
The module will be utilized as a part of the FDA’s rolling review process supporting the New Drug Application for ZYESAMI.
NRx’s CEO and Chairman, Prof Jonathan Javitt, said the company is continuing “efforts to ensure that NRx has the supply and logistics in place to provide ZYESAMI to patients where it is granted regulatory approval.”
In addition, the company has also been notified that a European Qualified Person Auditor has concluded an examination at a separate manufacturing facility with no adverse findings.
NRx is awaiting a Qualified Person declaration that the EU regulator needs to release ZYESAMI. The audit was completed ahead of the company submitting ZYESAMI to EU and United Kingdom health authorities.
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