Please ensure Javascript is enabled for purposes of website accessibility

Why NRX Pharmaceuticals Stock Is Jumping Today

By Keith Speights – Nov 11, 2021 at 11:55AM

Key Points

  • The FDA will allow NRx to manufacture Zyesami at commercial scale and extended the drug's shelf life.
  • NRx plans to move forward with seeking full FDA approval for the drug after the agency rejected its EUA request.

You’re reading a free article with opinions that may differ from The Motley Fool’s Premium Investing Services. Become a Motley Fool member today to get instant access to our top analyst recommendations, in-depth research, investing resources, and more. Learn More

The company received good news from the FDA.

What happened

Shares of NRx Pharmaceuticals (NRXP -1.60%) were up by 13.4% as of 11:13 a.m. EST on Thursday. The big gain came after the company announced that it had received a response from the Food and Drug Administration (FDA) related to its Oct. 8 submission of updated manufacturing information for anti-inflammatory drug Zyesami.

NRx Pharmaceuticals stated that the FDA's review allows the company to manufacture Zyesami at commercial scale in batches of between 10,000 and 100,000 doses. The shelf life for the drug was also extended from 62 days to 150 days. 

A person holding yellow blocks spelling FDA.

Image source: Getty Images.

So what

Thursday morning's nice move for the biotech stock reflected a big sigh of relief from investors. There were some concerns that the FDA might impose a clinical hold on Zyesami, but that didn't happen.

Now, NRx Pharmaceuticals can produce Zyesami in large quantities, and can also distribute the drug for clinical trials. This marks a major milestone for the company. Previously, Zyesami was essentially handmade in small, 300-dose batches.

The FDA has granted Fast Track designation for Zyesami as a treatment for patients with COVID-19. This designation allows NRx Pharmaceuticals to stay in close contact with the agency regarding development plans and clinical trial design. The company is currently evaluating the drug as a COVID-19 treatment in phase 3 studies being funded by the Department of Health and Human Services and the Department of Defense.

Now what

Last week, the FDA turned down NRx's request for an Emergency Use Authorization for Zyesami as a COVID-19 treatment. The company is now pursuing full FDA approval of the drug. NRx plans to work with the agency to complete the chemistry, manufacturing, and controls (CMS) section of its regulatory filing package.

Keith Speights has no position in any of the stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.

Premium Investing Services

Invest better with The Motley Fool. Get stock recommendations, portfolio guidance, and more from The Motley Fool's premium services.