NRx Pharmaceuticals Gets FDA Path For Depression Drug Approval

NRx Pharmaceuticals announced it received confirmatory minutes from an FDA Type C meeting outlining a path to New Drug Approval for NRX-100 (ketamine) to treat depression, including patients with suicidality, without requiring additional clinical trials.

• FDA willing to review existing clinical trial data as substantial evidence
• Real World Evidence from Osmind will serve as confirmatory evidence
• Company plans to submit New Drug Application by June 2026
• Ketamine demonstrated superiority to placebo and non-inferiority versus electroshock therapy
• Drug showed statistically significant reduction in suicidal ideation without memory loss
• NRx Pharmaceuticals shares are up about 4.3% premarket

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