By Chris Wack


NRx Pharmaceuticals shares were up 38% to $2.90 after the company said it saw a statistically significant safety advantage of NRX-101 compared to the standard of care comparator in its recently completed clinical trial in patients with suicidal bipolar depression.

The stock hit its 52-week low of $1.90 on May 2, and is still down 53% over the past 12 months.

The pharmaceutical company believes that demonstration of reduced akathisia in the setting of comparable antidepressant efficacy constitutes a basis for Accelerated FDA approval of NRX-101.

A 33% but statistically non-significant sustained decrease in suicidality was also seen favoring NRX-101.

Based on this safety finding, NRx plans to seek accelerated approval of NRX-101 for treatment of bipolar depression in patients at risk for akathisia who are at highest risk of suicide, while continuing to develop evidence to support broader indications both in treatment of depression and schizophrenia.


Write to Chris Wack at chris.wack@wsj.com


(END) Dow Jones Newswires

05-06-24 1349ET