NRXP

In advance of November 10, 2026, GDUFA goal date, all requested changes were classified as "MINOR."NRx was requested to prepare and submit labels with the proprietary name currently under review by FDA.NRx is currently completing final manufacturing Process Validation Runs to comply with product launch requirements. WILMINGTON, Del., Oct. 15, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (NASDAQ:NRXP, "NRx" or "the Company")), a biopharmaceutical company that focuses on neuroplastic therapies for depression, PTSD, and related conditions, today announces the receipt of a "DISCIPLINE REVIEW LETTER" from the US Food and Drug Administration requesting "MINOR" changes to the submitted lab

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

DARPA states that the program, if successful, will fundamentally change the Standard of Care for Treatment Resistant Depression. The Military has recognized that current treatments for depression are not deployable in operational military settings.The SPARC-TMS Single Day treatment protocol, which involves the use of Robotic Neuronavigated Transcranial Magnetic Stimulation (TMS) augmented by NRx’s neuroplastic investigational drug NRX-101, is based on a recently completed randomized-controlled trial funded by DARPA and published real world findings of 91% treatment response and 69% remission at 3 months post treatment with traditional TMS + D-cycloserine (an active ingredient of NRX-101).If

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

Abbreviated New Drug Application (ANDA) Amendment related to the drug vial for preservative-free ketamine has been reclassified from a Major Amendment to a Minor Amendment.FDA has revised the Generic Drugs User Fee Act (GDUFA) Goal Date to November 10, 2026. WILMINGTON, Del., Sept. 15, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) ("NRx Pharmaceuticals", "NRx" or the "Company"), a clinical-stage biopharmaceutical company, today announced that it has received a written communication from the Director of Regulatory Operations of the FDA Office of Generic Drugs advising the Company that the amendment to its Abbreviated New Drug Application (ANDA), previously classified as

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

Invention is based on the discovery that ALS may be caused by reactivation of Human Endogenous Retrovirus K (HERV K) Envelope protein (K Env), already coded in the "dark genome" of all people. K Env is found in the spinal fluid of more than 75% of people with ALS and has been shown to produce the neurodegenerative findings of ALS in experimental animals and human neuron cells. The patent (EP 3 570 878 B1) covers a novel monoclonal antibody (GNK-301) developed by GeNeuro and scientists at the US National Institute of Neurological Disorders and Stroke (NINDS) under a Cooperative Research and Development Agreement and co-owned under a subsequent patent agreement. Two US patents (10,723,787 an

HOPE is the first Interventional Psychiatry network to deploy Zeta Surgical's newly FDA-cleared TMS Robotic System; the HOPE clinical team is completing orientation and training at Zeta Surgical's headquarters in Boston ahead of deployment in HOPE's Florida clinicsThe Zeta TMS Robotic System's AI-driven software adjusts the TMS coil in real time with submillimeter precision, building on the Zeta TMS Navigation System HOPE implemented earlier this summerDeployment supports SPARC-TMS, NRx's trial of NRX-101 with robotic TMS, for which NRx is initiating a project for the military, in partnership with Harvard McClean Hospital.NRx Pharmaceuticals is participating in a fireside chat at the 2026 Ca

WILMINGTON, Del., Sept. 08, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) ("NRx Pharmaceuticals" or the "Company"), a clinical-stage biopharmaceutical company, today announced that the management team will participate in three upcoming investor conferences in September 2026. Moody Capital Solutions 2026 Disruptive Growth & Life Sciences ConferenceCompany PresentationPresenter: Jonathan Javitt, M.D., M.P.H., Founder, Chairman and Chief Executive Officer of NRx PharmaceuticalsLocation: New York, New YorkDate: September 9, 2026Presentation Time: 9:35-9:55 a.m. ET 2026 Cantor Global Healthcare ConferenceFireside ChatPresenter: Jonathan Javitt, M.D., M.P.H., Founder, Chairm

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

Key recent and second quarter highlights include: Completed first-cycle FDA review of the Company’s ANDA for preservative-free ketamine with no drug-related major deficiencies. The sole remaining item, a manufacturer's attestation on the vial, has been submitted to FDA.Initiation of commercial scale manufacturing of preservative-free ketamine building to launch stock of 5 million doses to be ready for commercialization in 2026.Selected by the Defense Advanced Research Projects Agency (DARPA) as prime contractor for SPARC-TMS, an FDA-approved Phase 2/3 trial of NRX-101 with robotic TMS. Anticipated non-dilutive funding exceeds $11.5 million, subject to completion of contractingThe Company is

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

MIAMI, Aug. 07, 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 and Q&A session on Monday, August 10, 2026 at 8:30 a.m. Eastern Time to discuss the FDA's completion of first-cycle review of the Company's ANDA for preservative-free ketamine, announced earlier today. Participating on the call will be Jonathan Javitt, MD, MPH, Founder and Chief Executive Officer; Glenn Tyson, Chief Commercial Officer; and Chaim Hurvitz, Director, former director of Teva and President of the Teva International Group. Questions will cover both the regulatory p

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

FDA identified no major deficiencies related to the ketamine drug product, ingredients, proposed labeling, CMC, or other drug-related review matters.Remaining item relates to manufacturer certification for a luer lock vial already used in three FDA-approved ANDA products with 11.9 million units shipped over the past 12 months without complaints, returns, adverse events, or recalls.No new clinical, safety, efficacy, or drug-related data are required for ANDA approval.Following an August 6, 2026 clarification meeting attended by senior FDA leadership, FDA committed to reviewing the requested certification in the shortest possible review cycle.NRX believes completion of first-cycle ANDA review

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

WILMINGTON, Del., June 25, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) ("NRx" or the "Company") today issued the following statement in response to recent public claims made by Kadima Neuropsychiatry Institute ("Kadima"). Kadima issued a public statement on June 24, 2026 making a series of unfounded allegations related to the non-acquisition of Kadima by HOPE Therapeutics, Inc., a majority-owned subsidiary of the Company ("HOPE"). As disclosed in recent filings with the Securities and Exchange Commission (the "SEC"), NRx has compelled arbitration with Kadima over Kadima’s failure to meet key closing conditions contemplated in the related transaction documents includin

First Zeta-navigated TMS treatments have begun at HOPE Therapeutics clinics in West Palm Beach and Sarasota, Florida, marking the transition from research deployment to active patient careAI-powered, sub-millimetric image guidance is now being applied in HOPE's outpatient TMS workflows for patients with Major Depressive Disorder and other CNS conditionsMilestone advances HOPE's interventional psychiatry platform and aligns with NRx's planned trial of NRX-101 in combination with robotic-enabled TMS in civilian and military treatment facilities (the SPARC-TMS trial). WILMINGTON, Del., June 25, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) ("NRx Pharmaceuticals", "NRx" or

SARASOTA, Fla, and BOSTON, June 23, 2026 /PRNewswire/ -- ZETA SURGICAL and HOPE Therapeutics, an NRx Pharmaceuticals company (NASDAQ:NRXP), today announced the first patient treatment with the FDA-cleared Zeta TMS Navigation System at a HOPE Therapeutics clinic in Sarasota. HOPE has installed Zeta TMS Navigation Systems at clinics in West Palm Beach and Sarasota, with Zeta-navigated patient treatments beginning at both locations this week. TMS is a non-invasive therapy used primarily for treatment-resistant depression, which affects approximately one-third of patients with major

D-Cycloserine (DCS) has been reported to augment the effect of Transcranial Magnetic Stimulation (TMS) in remission from depression and suicidality in several published clinical studies.NRx Pharmaceuticals is developing NRX-101, a fixed dose combination of DCS+lurasidone for the augmentation of TMS and has initiated a pivotal clinical trial in both civilian and military treatment facilities.The Expanded Access protocol is designed to make NRX-101 available under FDA-authorized compassionate care mechanisms for patients who cannot access the pivotal trial.Physicians who wish to provide NRX-101 in association with accelerated TMS for patients with Treatment-Resistant Depression may register at

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