NRx Pharmaceuticals (Nasdaq:NRXP) Reports First Quarter 2026 Financial Results and Provides Corporate Update

Key highlights from the first quarter of operations under the expanded management team include the following: Anticipated FDA decision on the Company's ANDA for Preservative-Free Ketamine in Q3 2026, with favorable preliminary determinations already received from the FDA Office of Generic Drugs on bioequivalence, labeling, drug product, drug substance, and safety. Initiation of commercial manufacturing of Ketamine at the 1 million dose per month level with recent FDA inspection of the manufacturing facility and granting of inspection status consistent with launch of an ANDA drug. Completed a Type C meeting with the FDA Division of Psychiatry Products and CDER leadership, in which the Agency expressed openness to existing clinical trial data and Real World Evidence supporting approval without additional trials. Presidential Executive Order signed and Congressional Appropriations Language filed encouraging the use of Real World Evidence in the approval of drugs for suicidal depression and PTSD. Appointment of Prof. Joshua Brown, MD, PhD (Harvard/McLean) as Chief Medical Innovation Officer, bringing NIH- and DARPA-funded expertise in D-cycloserine and TMS for depression, PTSD, and suicidality. FDA acceptance of an Investigational New Drug (IND) application for NRX-101 as an adjunct to robotic-enabled Transcranial Magnetic Stimulation (TMS), with anticipated non-dilutive federal funding supporting study at military and civilian sites. Development of a patentable, sustained-release formulation of D-cycloserine designed to enhance TMS efficacy, building on prior trial data showing a doubling of clinical response and 8-fold increase in remission versus standard TMS. First revenue generated from five interventional psychiatry clinics treating severe depression and PTSD, with funding from the VA, Department of War, private insurers, and self-pay; footprint expected to expand m