What happened
Shares of NRx Pharmaceuticals (NRXP +0.80%) 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.
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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.
