NRx Pharmaceuticals (NASDAQ: NRXP) announced it received a positive Discipline Review Letter from the FDA Office of Generic Drugs addressing quality-related aspects of its ketamine ANDA (Abbreviated New Drug Application), 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.
The company expects potential approval of its preservative-free ketamine product in summer 2026. NRx-100 (preservative-free intravenous ketamine) has been awarded Fast Track Designation for the treatment of suicidal ideation in depression, including bipolar depression. The company has also filed a New Drug Application with an application for the Commissioner’s National Priority Voucher Program for the treatment of suicidal ideation in patients with depression, including bipolar depression.
NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for central nervous system disorders, specifically suicidal depression, chronic pain, and PTSD. In addition to NRX-100, the company is developing NRX-101 (oral D-cycloserine/lurasidone), which has been awarded Breakthrough Therapy Designation for the treatment of suicidal bipolar depression. NRx maintains an extensive research portfolio of investigational novel serotonergic agonists.
This article is an AI-assisted summary. All facts and figures are drawn from the original report: https://www.financialcontent.com/article/nnwire-2026-4-22-biomednewsbreaks-nrx-pharmaceuticals-inc-nasdaq-nrxp-receives-positive-fda-review-letter-supporting-ketamine-anda-progress