NRXP

NRx has received a positive review letter (Discipline Review Letter) addressing Drug Quality requesting only "Minor" administrative changesNRx conducted a meeting with leadership of the FDA Office of Generic Drugs in which support was voiced for the potential approval of the Abbreviated New Drug Application within the current review cycle.Ketamine is identified as medically necessary by the US Department of Veterans Affairs for the treatment of suicidality and treatment-resistant depression.In addition to the current ANDA, NRx is in the process of submitting a New Drug Application to align the labeling of ketamine with its use in treating depression and suicidalityThe President's April 16, 2

President Trump signed an Executive Order: ACCELERATING MEDICAL TREATMENTS FOR SERIOUS MENTAL ILLNESS on April 18, 2026.The order directs acceleration of research and lowered barriers to approvals of psychedelic medications to treat depression, PTSD, and suicidality.NRx Pharmaceuticals has been awarded Fast Track designation and recently received FDA guidance anticipating NRx's upcoming New Drug Application for NRX-100 (preservative free ketamine) to treat depression, including bipolar depression, in patients who may have suicidal ideation.Suicide remains the second leading cause of death among Americans under the age of 35 and the only currently-approved treatment for suicidality in depress

Dr. Dennis K. McBride, PhD (CAPT, Medical Service Corps, US Navy, Ret., Distinguished Research Fellow, National Defense University, and former senior executive, Office Secretary of Defense) to serve as first President of NRx Defense SystemsDevelopment initiative to be conducted through NRx Defense Systems, Inc., a newly incorporated R&D subsidiary, in partnership with Zeta Surgical, Inc. Initial focus will be the development of Combined Neuroplastic Therapy including D-Cycloserine (NRX-101) and Robotic-enabled Transcranial Magnetic Stimulation in the military and first-responder setting MIAMI, April 15, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (NASDAQ:NRXP), a biopharmaceutical

Mr Tyson has both clinical experience treating patients with serious mental health disorders and 25 years of successful industry commercial experience in the development and sales of medications in this fieldMr. Tyson is appointed as NRx anticipates approval of an ANDA for preservative-free ketamine and near term submission of a New Drug Application to expand ketamine labeling to encompass depression and suicidality. WILMINGTON, Del., April 13, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (NASDAQ:NRXP), a biopharmaceutical company that focuses on neuroplastic therapies for depression, PTSD, and related conditions, today announces the appointment of Glenn Tyson as the company's first

NRx has received a letter from the FDA Office of Generic Drugs indicating preliminary alignment on labeling for NRx's preservative-free ketamine product. Labeling remains subject to final supervisory review.NRx previously received a preliminary determination of bioequivalence for this product.The Company continues to anticipate a decision on approval under the Generic Drug User Fee Act (GDUFA) in Summer 2026. WILMINGTON, Del., April 06, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (NASDAQ:NRXP), a clinical-stage biopharmaceutical company, today announced that it has received a letter from the Labeling Program of the FDA Office of Generic Drugs whose only comments were limited to min

Hope Therapeutics ((subsidiary of NRx Pharmaceuticals, NASDAQ:NRXP) partners with Emobot Health to deploy its AI-powered "Depression Thermometer" across its interventional psychiatry clinic network.Emobot's platform passively monitors depression, bipolar disorder and anxiety disorders via smartphone — replacing burdensome questionnaires with background analysis of facial expressions, vocal tones, and actigraphy.The partnership targets the critical "blind spot" in TRD care: ~50% of patients relapse within 6–12 months, often undetected between clinic visits.Clinical validation across three prospective studies shows strong concordance with MADRS (r=0.89) and PHQ-9 (r=0.83), providing an objecti

8-K - NRX Pharmaceuticals, Inc. (0001719406) (Filer)

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 wi

10-K - NRX Pharmaceuticals, Inc. (0001719406) (Filer)

WILMINGTON, Del., March 19, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced that it will host a conference call at 8:00am ET on Tuesday, March 24, 2026. In addition to reviewing the Company's financial results for the fiscal year ended December 31, 2025, the Company will provide an update on the significant progress achieved across its drug development programs and the HOPE Therapeutics clinical network, milestones that bring the Company closer to its founding mission of preventing suicide and transforming the treatment of depression and PTSD to improve the lives of patient

Determination of bioequivalence to the Reference Listed Drug is essential for approval of an Abbreviated New Drug Application (ANDA).FDA has advised NRx in written correspondence that it has not identified any bioequivalence deficiencies in the Company's Preservative-Free Ketamine product. This communication is deemed preliminary until final supervisory review.NRx continues to anticipate an FDA GDUFA decision on its ANDA application in Summer 2026 as previously announced.The ANDA process is focused on offering a preservative-free alternative in the existing ketamine market through the FDA Office of Generic Drugs and is separate from NRx's path to a New Drug Application to use ketamine in the

NRx has received confirmatory FDA minutes from in-person Type C meeting attended by leadership of FDA Division of Psychiatry, FDA Office of Neuroscience, and FDA Center for Drug Evaluation and Research.Minutes are consistent with previously announced oral guidance outlining a path to New Drug Approval of NRX-100 for a broadened indication of treating depression, including patients with suicidality.FDA confirmed willingness to review existing Adequate and Well Controlled Clinical Trial data as Substantial Evidence of Efficacy together with Real World Evidence from Osmind, Inc. as confirmatory evidence of efficacy.No additional clinical trials were requested.Company intends to sumbit its New D

Published results have shown 87% clinical response to non-invasive Transcranial Magnetic Stimulation with neuroplastic medications.Clinical leadership by physicians trained at Harvard, Johns Hopkins, Georgetown, and other leading Universities.Now accepting patients, call 1-833-4HOPETMS WEST PALM BEACH, Fla., March 09, 2026 (GLOBE NEWSWIRE) -- HOPE Therapeutics, a subsidiary of NRx Pharmaceuticals, Inc. (NASDAQ:NRXP), today announced the opening of its Palm Beach, FL clinic location dedicated to the treatment of Depression and PTSD with an interventional psychiatry approach that includes ketamine1 and other neuroplastic drugs, transcranial magnetic stimulation (TMS), and hyperbaric oxygen,

Prof. Brown is a pioneer in Transcranial Magnetic Stimulation (TMS) and serves as current President of the Clinical TMS Society and Editor-in-Chief of the Transcranial Magnetic Stimulation journal.Extensive publication history in the science of neuroplasticity and its relationship to healing depression and PTSD.Unique background in charting a path for forward deployment of TMS with neuroplastic medication to treat depression and PTSD in military personnel, veterans, and first responders. WILMINGTON, Del., March 02, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (NASDAQ:NRXP), a clinical-stage biopharmaceutical company, today announced that it has appointed Prof. Joshua C. Brown, MD, P

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8-K - NRX Pharmaceuticals, Inc. (0001719406) (Filer)

8-K - NRX Pharmaceuticals, Inc. (0001719406) (Filer)

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NRx together with Osmind, Inc. conducted an in-person meeting attended by leadership of the FDA Division of Psychiatry Products and leadership of the FDA Center for Drug Evaluation and Research (CDER)Oral guidance received at the meeting provides a path to filing an application for New Drug Approval of NRX-100 under already-awarded Fast Track Designation based on existing clinical trial data and Real World EvidenceBased on the guidance, NRx will seek a broader proposed indication for NRX-100 to serve patients with treatment-resistant depression who may have suicidality rather than only the subset with suicidality WILMINGTON, Del., Feb. 17, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, I

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8-K - NRX Pharmaceuticals, Inc. (0001719406) (Filer)

8-K - NRX Pharmaceuticals, Inc. (0001719406) (Filer)