NRx Pharmaceuticals (NRXP) NRX-101 Gains FDA Expanded Access Approval

NRx Pharmaceuticals (NRXP) announced on June 22, 2026, that the U.S. Food and Drug Administration (FDA) approved an Expanded Access Protocol (EAP) for its investigational drug, NRX-101. This approval allows intermediate population patients suffering from Suicidal Depression and Bipolar Depression to access NRX-101, particularly those ineligible for ongoing clinical trials. NRX-101 is a once-daily oral antidepressant that previously received FDA Breakthrough Therapy Designation for the treatment of Bipolar Depression with Suicidal Ideation. The EAP provides a crucial pathway for patients who have failed other treatments and cannot participate in current studies to receive the therapy.