NRx Pharmaceuticals Completes Three Process Validation Lots Of Preservative Free Ketamine Produced Under Commercial Conditions In Anticipation Of Nov. 10 Generic Drug User Fee Amendments Goal Date

NRx Pharmaceuticals, Inc. (Nasdaq: NRXP, "NRx" or "the Company"), a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA receptor platform for the treatment of central nervous system disorders, today announces completion of three Process Validation lots of preservative free Ketamine produced under commercial conditions in anticipation of the November 10 GDUFA (Generic Drug User Fee Amendments) Goal Date. Process Validation1 is the final step in the drug manufacturing process required to demonstrate compliance with FDA Good Manufacturing Practices (GMP).

In related developments, NRx has now completed analysis of two-year room temperature real-time stability data on preservative-free ketamine demonstrating no deterioration in purity, potency, or sterility without the need for toxic preservatives. The Company believes that these data will be consistent with a labeled shelf life of three years or longer.