NRx Pharma Files Breakthrough Therapy Designation Request For ZYESAMI

(RTTNews) - NRx Pharmaceuticals (NRXP) has filed a new Breakthrough Therapy Designation request for ZYESAMI focused on patients with critical COVID-19 and respiratory failure who are at immediate risk of death despite treatment with remdesivir and other approved therapies. The company said the filing is based on FDA request for clinical data on the effectiveness of ZYESAMI compared to Remdesivir and other approved therapies.

The FDA recently declined Emergency Use Authorization and Breakthrough Therapy Designation for ZYESAMI and invited a new request. Based on the FDA's input, the company has narrowed its Breakthrough Therapy Designation request to treatment of COVID-19 respiratory failure in patients who progress despite treatment with remdesivir and other approved therapies.

Shares of NRx Pharmaceuticals were up 17% in pre-market trade on Wednesday.