NRx files new BTD request for COVID-19 treatment, after FDA declined previous request

nrx-files-new-btd-request-for-covid-19-treatment,-after-fda-declined-previous-request

Shares of NRx Pharmaceuticals Inc. NRXP, -4.66% soared 17.8% in premarket trading Wednesday, after the drug development company said it filed a new Breakthrough Therapy Designation (BTD) with the U.S. Food and Drug Administration for Zyesami in patients at immediate risk of death from COVID-19, despite treatment with Remdesivir. The FDA had previously declined Emergency Use Authorization (EUA) and BTD for Zyesami, but had invited a new request based on new clinical evidence. NRx said it has narrowed its BTD request to treat COVID-19 respiratory failure in patients who progress despite treatment with remdesivir and other approved therapies. “At a time when America is entering a new COVID-related crisis, we thank the FDA for encouraging us to address the subset of patients who have no other approved treatment,” said NRx Chief Executive Jonathan Javitt. The stock, which matched its record low close of $4.50 on Tuesday, has plummeted 81.6% this year, while the S&P 500 SPX, -0.10% has advanced 27.4%.

Source: Marketwatch

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