NRx Pharmaceuticals (NASDAQ:NRXP) stock is advancing in early trading today after the company announced that it was seeking breakthrough therapy designation from the U.S. Food and Drug Administration for its Covid-19 treatment, Zyesami, for the second time.
In mid-morning trading, NRXP stock rose 4% to $4.68.
The New Data on Zyesami
According to NRx, Covid-19 patients treated with the drug were 2.8 times more likely to avoid both death and respiratory failure 28 days and 60 days after they began using the medicine than those given placebos.
Patients treated with Zyesami after Gilead’s (NASDAQ:GILD) Remdesivir failed to stop their respiratory failure were four times more likely to survive than those who received placebos.
Among all 196 Covid-19 patients who received NRx’s drug, the survival rate was double those who were given placebos. But much more encouraging was the data on 70% of those whose condition was worsening after being treated with Gilead’s remdesivir drug and other approved drugs. Among that group, the patients who received Zyesami were four times more likely to survive at the 60-day mark than those who were given placebos.
Finally, the patients who were on ventilators were ten times more likely to survive if they were given Zyesami.
Background on NRXP Stock
The FDA had previously decided not to give breakthrough designation to Zyesami or grant an emergency-use authorization for the drug. The agency, however, had suggested that NRx could reapply for breakthrough designation if new data on the drug showed that it could be meaningfully more effective than other approved therapies.
NRx is now seeking to have the agency grant breakthrough designation to its drug as a “treatment of COVID-19 respiratory failure in patients who progress despite treatment with remdesivir and other approved therapies.”
The FDA grants breakthrough designation to drugs in order to reduce the time needed for them to be enhanced by companies and evaluated by the agency. The status is only given to drugs that have shown the potential, in clinical trials, to “treat a serious condition” significantly more effectively than “available” drugs.
Worth noting is that NRXP stock has lost about 80% of its value since peaking at nearly $25 in July 2021. The shares now have a market capitalization of just under $300 million.
Sorrento Therapeutics (NASDAQ:SRNE), another small drug maker, began developing treatments for the coronavirus in the early months of the pandemic. Over the last year, its shares have tumbled 33%.
On the date of publication, Larry Ramer did not have (either directly or indirectly) any positions in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.
