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NRx Pharma : FDA Denies Breakthrough Therapy Designation Request For Zyesami

NRx Pharmaceuticals Inc. (NRXP) said that the U.S. Food and Drug Administration denied the breakthrough therapy designation request for Zyesami or aviptadil and emphasized its focus on the company's NRX-101 BTD compound for Bipolar Depression associated with Suicidality.

The request for breakthrough therapy designation was submitted based on the positive finding of a post-hoc subgroup analysis of patients who in addition to Aviptadil or placebo were also treated with Remdesivir and whose respiratory failure due to Critical COVID-19 continued to progress.

The company noted that it will further evaluate the options for Zyesami's use in other high unmet pulmonary as well as other non-pulmonary indications.

"Although we are disappointed about FDA's decision, as recently announced, our strategic focus has already shifted to the advancement of our Breakthrough Therapy designation drug NRX-101," the company said. The company expects topline data for its ongoing Phase II study of NRX-101 in patients with bipolar depression with sub-acute suicidal ideation (SSIB) by the end of the year.

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