What happened
Shares of NRx Pharmaceuticals (NRXP 2.29%) had skyrocketed 43.6% as of 12:07 p.m. EDT on Monday. The big jump came after the company presented data that showed Zyesami (aviptadil) could help prevent cytokine storms in patients with COVID-19. Cytokine storms occur when inflammatory cytokines, which are proteins that play an important role in cell signaling, are produced at much higher rates than normal.
So what
NRx reported that patients treated with Zyesami in a phase 2b/3 clinical study experienced a much lower increase in interleukin 6 (IL-6) cytokine levels. This lower increase was observed in patients with different levels of severity of COVID-19. The drugmaker also stated that Zyesami's effect on cytokine activity was "associated with a significant decrease in 60-day mortality."
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With COVID-19 cases increasing in many parts of the U.S., NRx's news understandably provided a big catalyst for the biotech stock. Zyesami hasn't won regulatory approval or authorizations yet. However, NRx filed for Emergency Use Authorization (EUA) for the drug in June.
Now what
NRx said that it has already submitted the latest findings about Zyesami's anti-cytokine effects to the Food and Drug Administration as a supplement to its EUA filing. The company also plans to submit a biomarker qualification letter of intent to the FDA. This could pave the way for an easier path to full FDA approval for the drug.
