Data is currently not available
Jun 11, 2022 12:02AM EDT
(RTTNews) – 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.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
Founded in the late 1990s by Andrew Mariathasan in New York, with the goal of covering Wall Street for a new generation of investors, RTTNews has expanded steadily over the years to become a trusted provider of content for a wide array of subjects across several platforms. RTT’s Financial Newswire is relied upon by some of the world’s largest financial institutions, including banks, brokerages, trading platforms and financial exchanges.
Source : Nasdaq