NRx Pharmaceuticals (NRXP) Stock Flies On COVID-19 News

NRx Pharmaceuticals Inc (NASDAQ: NRXP) is screaming for the top in the market this morning, trading on gains of more than 70%, and for good reason. The company announced the coming presentation of positive data surrounding its potential COVID-19 treatment. Here’s what’s happening:

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NRXP Stock Climbs On Coming Data Presentation

In the press release, NRx Pharmaceuticals said that it will be presenting at the Disease Control and Prevention Summit on July 21, 2021. The online presentation will be available here

In the release, the company said that it plans on presenting evidence that ZYESAMI, also known as aviptadil, helps to prevent cytokine storm in patients with COVID-19. 

NRXP went on to say that the presentation identifies a statistically significant effect of ZYESAMI in preventing the sharp rise in cytokines, commonly associated with mortality in COVID-19 patients. 

The data came from a recently-completed Phase 2b/3 trial where patients treated with placebo experienced a statistically significant elevation in interleukin 6 cytokine levels. Those treated with ZYESAMI had a minimal increase in IL-6. 

Importantly, change in cytokine level was a prespecified endpoint of the study. 

In the release, NRXP went on to say that health regulators continue to prioritize therapies for COVID-19 that help block the impact of IL-6 cytokines. The anti-cytokine effect of ZYESAMI was additionally associated with a significant decrease in 60-day mortality. 

NRx Pharmaceuticals went on to explain that the data were collected as part of the phase 2b/3 trial of ZYESAMI compared to placebo, in critically ill patients with COVID-19 respiratory failure. The effect was noted across a diverse set of patients, suffering from different levels of disease severity and treated in both tertiary care and community hospitals. 

The company has submitted the data to the FDA as a supplement to its pending application for Emergency Use Authorization, and is submitting a biomarker letter of intent to the FDA as part of its biomarker program, authorized under the 21st Century Cures Act. 

Management Commentary

In a statement, Professor Jonathan Javitt, MD, MPH, Chairman and CEO at NRXP, had the following to offer:

At a time when hospital admissions for COVID are rising worldwide, these placebo-controlled biomarker data suggest that aviptadil may play a critical role in preventing the sudden elevation of cytokines that is associated with mortality.

This linkage between the clinical effect of aviptadil on survival and recovery and a measurable biologic change in cytokine levels provides a basis for seeking a biomarker-based regulatory path as envisioned by the 21st Century Cures Act. The lethal impact of “cytokine storm” is associated with mortality in a variety of lethal conditions including Acute Respiratory Distress Syndrome, a common cause of death in sepsis, and amniotic fluid embolus, a primary cause of maternal death during pregnancy.

This News Is Huge

First and foremost, positive Phase 3 data is always great news, and that seems to be what’s happening here. The Phase 2b/3 study seems to have gone well and the treatment is associated with the prevention of cytokine storm. 

That means that the company is well on its way to potential FDA approval for COVID-19 patients, which alone is exciting. After all, it has the potential to drive billions of dollars in revenue. 

However, this can be taken a step further, and the opportunity is likely much bigger than you think. 

Cytokine storm wasn’t talked about much among the investing community until the COVID-19 outbreak, but it has been an issue in the medical community for some time. Often, cytokine storms are related to mortality in patients with various forms of cancer, and few therapeutic options have ever shown efficacy in stomping out the issue. 

With that said, not only are we looking at a potentially lucrative treatment for patients with COVID-19, this therapy may be able to be combined with certain cancer therapies to improve outcomes for this massive patient population as well. 

All told, this data is huge for a number of reasons, all of which could add up to significant revenues for NRXP ahead. 

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The Bottom Line

The bottom line here is simple. NRXP seems to be on the right track with their ZYESAMI treatment, and should all continue to go well, it will hit the market soon. Not only does the therapy offer a huge short-term opportunity in the COVID-19 space, but the oncology-related applications may prove to be even more valuable down the road. All in all, if you’re not watching the stock yet, you’re missing out. 

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