Business
NRx Pharmaceuticals (Nasdaq:NRXP) Reports Full-Year 2025 Results and Highlights Key Regulatory and Commercial Progress
Key highlights for the first full year of operation under the new management team include: A year-over-year reduction in operating expenses with $7.8 Million
About this update from Nrx Pharmaceuticals, Inc.
[{"type":"text","content":"Key highlights for the first full year of operation under the new management team include: A year-over-year reduction in operating expenses with $7.8 Million cash on hand at year end. With ongoing revenue from operations and current ATM trends, the Company anticipates adequate resources to support operations through 2026, with anticipation of continued revenue growth. As of December 31, 2025, all previously issued convertible debt had been converted into common stock.Anticipated FDA approval of at least one new drug – Preservative Free Ketamine under an ANDA—during Q3 2026. A favorable preliminary bioequivalence determination was received from the FDA last week.A Type C in-person meeting with the FDA Division of Psychiatry Products together with leadership of the FDA Center for Drug Evaluation and Research (CDER) to identify a path to approval of NRX-100 (preservative-free ketamine) under a New Drug Application with an indication for treatment of Severe Depression in Patients who may have suicidality. In meeting minutes, FDA expressed willingness to review existing randomized clinical trial data and Real World Evidence as a potential basis for approval without a requirement for conduct of additional clinical trials.Appointment of Prof. Joshua Brown, MD, PhD, of Harvard/Mclean as Chief Medical Innovation Officer. Dr. Brown is Principal Investigator on NIH- and DARPA-funded projects that highlight the future of neuroplastic care, including use of D-cycloserine and TMS for treating depression, PTSD, and suicidality.Filing of an Investigational New Drug application with the FDA to study the use of NRx’s Breakthrough-designated candidate, NRX-101, for the enhancement of Transcranial Magnetic Stimulation (TMS) supported by non-dilutive governmental funding sources.Development of a patentable, sustained-release presentation of D-cycloserine to provide an extended release profile suitable for enhancement of TMS efficacy. Prior clinical trials have shown a doubling of clinical response in patients with depression and an 8-fold increase in remission from depression versus standard TMS therapy.Implementation of a business plan for HOPE Therapeutics, Inc. with the aim of developing interventional psychiatry centers focused on neuroplastic therapy – including ketamine, D-cycloserine, Transcranial Magnetic Stimulation, and Hyperbaric Oxygen T...