NRx Pharmaceuticals, Inc. (NRXP) said it had received formal written minutes from a recent Type C meeting with the U.S. FDA, confirming a clear path to submit an NDA for NRX-100, its preservative-free ketamine formulation for severe depression, including patients with suicidal ideation.
The FDA indicated it is willing to review the company's existing adequate and well-controlled clinical trial data as substantial evidence of efficacy, supported by real-world evidence from Osmind, Inc. Importantly, the agency did not request any additional clinical trials, removing a major regulatory uncertainty for the program.
NRX-100 has shown strong clinical performance in prior studies, demonstrating superiority to placebo and active placebo, and non-inferiority to electroconvulsive therapy- the only currently approved treatment for suicidal ideation. The company noted that ketamine also reduced suicidal thoughts in clinical trials, without the memory-loss risk associated with electroshock therapy.
Based on the FDA's guidance NRx now plans to pursue a broader indication covering treatment of severe depression in patients who may have suicidal ideation, rather than limiting the label to suicidality alone. According to the CDC, more than 16 million Americans experience depression each year, and 3.6 million contemplate suicide.
The FDA also confirmed that no additional nonclinical studies or bridging studies are required to support the NDA for the preservative-free formulation, which is expected to offer at least three years of room-temperature stability. NRx said it intends to submit the NDA by June 2026.
In addition to the upcoming NDA, the company has a pending Abbreviated NDA for preservative-free ketamine under its current anesthesia label, with an FDA decision expected in Summer 2026.
NXRP has traded between $1.58 and $3.84 over the past year. The stock currently trading at $2.21, up 18.61%.
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June 12, 2026 17:14 ET Major central bank action was the focus this week in economic news. The European Central Bank became the first major central bank to move in response to the rising inflationary pressures in the backdrop of the conflict in the Middle East. In North America, the U.S. inflation and trade data as well as Canada’s central bank decision gained attention. The Chinese trade data was the main news in Asia.