BioMedNewsBreaks – NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) Receives FDA Guidance Supporting NDA Review For NRX-100

NRx Pharmaceuticals (NASDAQ: NRXP) announced that minutes from a Type C meeting with the U.S. Food and Drug Administration support the agency’s willingness to review a New Drug Application for NRX-100, a preservative-free ketamine formulation, based on existing clinical trial data demonstrating substantial evidence of effectiveness without requiring additional clinical trials. The company said the FDA also confirmed openness to reviewing Real World Evidence as confirmatory data and indicated no additional nonclinical or bridging studies would be required, while NRx plans to pursue a primary indication for treating severe depression in patients who may experience suicidal ideation and continues to await a Summer 2026 decision on a separate Abbreviated New Drug Application for preservative-free ketamine for anesthesia use.

To view the full press release, visit https://ibn.fm/E5cDp

About NRx Pharmaceuticals, Inc.

NRx Pharmaceuticals, Inc. (www.nrxpharma.com), is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal depression, chronic pain, and PTSD. The Company is developing NRX-100 (preservative-free intravenous ketamine) and NRX-101, (oral D-cycloserine/lurasidone). NRX-100 has been awarded Fast Track Designation for the treatment of Suicidal ideation in Depression, including Bipolar Depression. NRX-101 has been awarded Breakthrough Therapy Designation for the treatment of suicidal bipolar depression. NRx has filed an Abbreviated New Drug Application (ANDA), and initiated a New Drug Application filing for NRX-100 with an application for the Commissioner’s National Priority Voucher Program for the treatment of suicidal ideation in patients with depression, including bipolar depression.

NOTE TO INVESTORS: The latest news and updates relating to NRXP are available in the company’s newsroom at https://ibn.fm/NRXP

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