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 meaningfully in 2026.
Pending acquisition of Geneuro, SA assets through a now complete Swiss court-supervised liquidation process, including a patent portfolio, antibodies, cell lines, and Phase 2 data targeting HERVs implicated in Schizophrenia, ALS, MS, Autism, and Type 1 Diabetes.
WILMINGTON, Del., May 18, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) ("NRx", the "Company", "we", "us" or "our") a clinical-stage biopharmaceutical company, today announced financial results for the quarter ended March 31, 2026, and provided a corporate update. The quarter was marked by continued progress advancing NRx's drug candidates toward commercialization, further development of the HOPE Therapeutics subsidiary, FDA acceptance of an IND for a federally-supported trial of NRX-101 as an adjunct to robotic Transcranial Magnetic Stimulation (TMS), and the pending acquisition of a Phase 2 monoclonal antibody portfolio targeting Human Endogenous Retroviruses (HERVs) implicated in Schizophrenia, Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), Autism, and Type 1 Diabetes.
"The first quarter of 2026 was a pivotal one for NRx, as we advanced two lifesaving drugs towards FDA approval with the aim of initiating commercial pharmaceutical operations by the end of this year. We started the year debt-free, and made targeted investments in several critical strategic operating initiatives that drove 1) substantial progress toward the approval of our first drug product, 2) initiated commercial manufacture in anticipation of drug launch, 3) advanced profitable clinic operations with an expanded footprint, 4) burgeoned our overall intellectual property portfolio, 5) augmented our development pipeline and 6) attracted fundamental long-term investors who believe in our mission," said Dr. Jonathan Javitt, the Company's CEO and Chairman. "We are deeply grateful for the trust that has been afforded to us by our patients, their families, and our shareholders."
Key Research and Development and Corporate Activities
NRX-100 and KETAFREE™ (Preservative-Free Ketamine)
NRx advanced ...
