NRX Therapeutics shares surge 16.67% intraday as FDA meeting confirms NDA path for NRX-100 ketamine, expands indication to severe depression with suicide risk, no additional trials required.

NRX Therapeutics surged 16.67% intraday as the FDA confirmed the NDA path for NRX-100 ketamine, accepting existing clinical trial data and real-world evidence from Osmind without requiring additional trials. The company plans to submit its NDA by June 2026, with the FDA supporting the expansion of the indication to treat severe depression, including patients with suicidal tendencies.