NRXP

Osmind presented a retrospective comparative study of de-identified electronic health record data in a sample of 8,224 patients with treatment resistant depression treated with IV ketamine and 1,830 patients treated with intranasal esketamine from 800 community psychiatry clinics.IV ketamine patients demonstrated significantly higher rates of remission (OR 1.51; P<.001) from depression and response (OR 1.22; P<.003) compared to patients treated with nasal esketamine.The primary study limitation is that treatment assignments were not randomized.Use of Real World Evidence for approval of drugs to treat depression has been emphasized in a recent White House Executive Order and recent Congressio

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

WILMINGTON, Del., June 04, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) ("NRx Pharmaceuticals" or the "Company"), a clinical-stage biopharmaceutical company, today announced the closing of its previously announced underwritten public offering (the "Offering") of shares of its common stock, par value $0.001 per share ("Common Stock") at a public offering price of $3.50 per share of Common Stock. The gross proceeds of the Offering were approximately $22.3 million before deducting underwriting discounts and commissions in the Offering and other estimated expenses payable by the Company, including exercise of the underwriters' option to purchase additional shares of common

424B5 - NRX Pharmaceuticals, Inc. (0001719406) (Filer)

WILMINGTON, Del., June 03, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) ("NRx Pharmaceuticals" or the "Company"), a clinical-stage biopharmaceutical company, today announced the pricing of an underwritten public offering (the "Offering") of 5,714,286 shares of its common stock, par value $0.001 per share ("Common Stock") at a public offering price of $3.50 per share of Common Stock. The Company has also granted the underwriters a 30-day option to purchase up to an additional 857,142 shares of Common Stock. The gross proceeds of the Offering will be approximately $20.0 million (or $23.0 million if the underwriter exercises its option to purchase additional shares of Co

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

424B5 - NRX Pharmaceuticals, Inc. (0001719406) (Filer)

WILMINGTON, Del., June 02, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) ("NRx Pharmaceuticals" or the "Company"), a clinical-stage biopharmaceutical company, today announced that it intends to offer shares of its common stock, par value $0.001 per share ("Common Stock") in an underwritten public offering (the "Offering"). The Company also expects to grant to the underwriter of the Offering a 30-day option to purchase up to an additional 15% of the shares of Common Stock sold in the Offering on the same terms and conditions. The Offering is subject to market and other conditions, and there can be no assurance as to whether or when the Offering may be completed or as to t

EMOCARE is a smartphone-based passive monitoring tool that generates a continuous, real-time measure of depression from patient voice, facial expression, motion, and screen behavior, and is the first passive monitoring tool for psychiatric conditions.Pooled analysis of three prospective observational studies demonstrated 90% within-person concordance between EMOCARE scores and clinician-rated MADRS (r = 0.895; p = 0.016).EMOCARE also achieved strong sensitivity to symptom change against PHQ-9 (ρ = 0.834; p < 0.001) on consecutive-visit measurements.The validated technology is being deployed across the Hope Therapeutics interventional psychiatry network as a patient-facing self-monitoring and

Deployment at HOPE's West Palm Beach clinic brings AI-powered, sub-millimetric image guidance to the delivery of Transcranial Magnetic Stimulation (TMS) for patients with Major Depressive Disorder and other neurological conditionsInstallation complements HOPE's interventional psychiatry platform and aligns with NRx's previously announced clinical trial of NRX-101 in combination with robotic-enabled TMS WEST PALM BEACH, Fla., May 27, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) ("NRx Pharmaceuticals", "NRx" or the "Company"), a clinical-stage biopharmaceutical company, today announced that its wholly-owned subsidiary, HOPE Therapeutics, Inc. ("HOPE"), has become the fir

25-NSE - NRX Pharmaceuticals, Inc. (0001719406) (Subject)

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 e

SCHEDULE 13G/A - NRX Pharmaceuticals, Inc. (0001719406) (Subject)

WILMINGTON, Del., May 14, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced that it will release its first quarter 2026 financial results before the market opens on Monday, May 18, 2026 via press release, which will be available on the Company's website at https://ir.nrxpharma.com/. The Company will host a conference call at 8:00am ET the same day. A live webcast of the conference call will be available on the Company's website at https://ir.nrxpharma.com/events. Participants that are unable to join the webcast can access the conference call via telephone by dialing domestica

Preliminary research suggests that D-cycloserine significantly enhances the effect of Transcranial Magnetic Stimulation (TMS) Trial is planned to be conducted at a leading US academic teaching hospital, three HOPE Therapeutics Clinics, and two military treatment facilitiesCompany targeting non-dilutive funding to support enrollment of 400 patients Should the trial yield successful results, D-cycloserine-augmented TMS could play a significant role in the readiness of first responders, military personnel, and others affected by Treatment-resistant Depression WILMINGTON, Del., May 07, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals (NASDAQ:NRXP) announces receipt of clearance from the US Food a

Based on FDA Office of Generic Drugs guidance previously announced, NRx has transmitted an initial GMP manufacturing order to its US-based manufacturer.NRx has completed confirmatory GMP audits of manufacture and is prepared for pre-approval inspection.Initial manufacture rate is sufficient to support significant market penetration in first year sales and can be readily scaled based on blow-fill-seal manufacturing process. WILMINGTON, Del., May 05, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (NASDAQ:NRXP), a biopharmaceutical company that focuses on neuroplastic therapies for depression, PTSD, and related conditions, today announces initiation of a first commercial manufacturing or

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)