BioMedNewsBreaks — NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) Receives Positive FDA Review Letter Supporting Ketamine ANDA Progress

NRx Pharmaceuticals (NASDAQ: NRXP) announced it received a positive Discipline Review Letter from the FDA Office of Generic Drugs covering quality-related aspects of its ketamine ANDA, with only minor administrative updates requested. The company also reported a supportive meeting with FDA leadership aligned with federal priorities to accelerate treatments for severe mental illness, reinforcing expectations for potential approval of its preservative-free ketamine product in summer 2026.

To view the full press release, visit https://ibn.fm/dL8aD

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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