What happened
Shares of NRx Pharmaceuticals (NRXP +11.83%) surged on Monday after the healthcare company released promising clinical trial data for its investigational COVID-19 treatment, aviptadil. By the close of trading, NRx's stock price was up 20% after rising as much as 53.9% earlier in the day.
So what
An analysis conducted by respected statistician Dr. David Schoenfeld found that patients treated with aviptadil had a significantly higher probability of recovering from critical COVID-19 and respiratory failure than those who received existing therapies.
Among those who previously received Gilead Sciences' (GILD +0.15%) remdesivir, patients treated with aviptadil were 2.5 times more likely to be alive and free of respiratory failure at 60 days than those who received a placebo.
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"The study provides preliminary evidence that aviptadil is effective in increasing the odds of recovery and survival from respiratory failure among the sickest COVID patients," Dr. Schoenfeld said.
Now what
The U.S. Food and Drug Administration (FDA) recently chose to not grant Emergency Use Authorization (EUA) for aviptadil. Yet NRx intends to submit a new EUA request based on these promising results.
Meanwhile, the drug remains in phase 3 trials funded in part by the U.S. National Institutes of Health (NIH).
"The definitive findings on our medicine will come from the global trial currently being conducted by the NIH, which is more than halfway enrolled," NRx CEO Jonathan Javitt said in a press release. "However, at a time when COVID deaths are surging, we hope that the FDA will consider these new clinical findings in patients who have exhausted currently approved therapies."
