NRX Pharmaceuticals Inc (NRXP) News Today

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.

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”).

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 care AI-powered, sub-millimetric image guidance is now being applied in HOPE's outpatient TMS workflows for patients with Major Depressive Disorder and other CNS conditions Milestone 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.

SAN DIEGO--(BUSINESS WIRE)--Kadima Neuropsychiatry Institute and its founder, Dr. David Feifel, have filed a complaint against NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) and two of its subsidiaries in San Diego County Superior Court, alleging breach of contract and misrepresentation in connection with an acquisition agreement that the defendants warranted they had the financial capacity to close. The planned transaction represents a significant percentage of NRx's current market capitalization. T.

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.

WILMINGTON, Del., June 22, 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 approval by FDA of an Intermediate Population Expanded Access Protocol for the use of NRX-101, a fixed dose combination of D-cycloserine (DCS) and lurasidone for the augmentation of accelerated Transcranial Magnetic Stimulation (TMS). Expanded Access Protocols are part of FDA's compassionate care approach to making investigational drugs available to patients with serious or life-threatening medical conditions1.

MIAMI, June 05, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals (Nasdaq:NRXP, “the Company”) announces the presentation of a peer-reviewed poster at the 2026 American Society of Clinical Psychopharmacology annual conference documenting Real World Evidence of effectiveness associated with the use of intravenous (IV) ketamine to treat depression compared to intranasal esketamine. The presentation, entitled “Real World Evidence of Clinical Treatment Response Following Intravenous Racemic Ketamine Versus Intranasal Esketamine in Adults with Major Depressive Disorder” was jointly authored by Robert Dougherty, Emily Shih, Jamie Lo, and Jimmy Qian of Osmind, Inc., and Prof. Samuel Wilkinson, MD, of Yale University Department of Psychiatry.

Offering was led by B Group Capital with significant participation from, among others, Columbia Threadneedle Investments, Corbets Capital, Venture 76, and Mossrock Capital Offering was led by B Group Capital with significant participation from, among others, Columbia Threadneedle Investments, Corbets Capital, Venture 76, and Mossrock Capital

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.

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 the actual size or terms of the Offering.

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).

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 conditions Installation 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 first commercial site to deploy Zeta Surgical's FDA-cleared Zeta TMS Navigation System.

NRx Pharmaceuticals (NRXP) is downgraded from 'Buy' to 'Sell' following failures in ZYESAMI and NRX-101 clinical trials. Company's KETAFREE and NRX-100 programs offer potential, but face significant regulatory, competitive, and market uncertainties. KETAFREE ANDA review is set for July 29, 2026; NRX-100 NDA filing expected Q2 2026, targeting suicidal depression.

NRx Pharmaceuticals, Inc. (NRXP) Q1 2026 Earnings Call Transcript

NRx Pharmaceuticals NASDAQ: NRXP said it advanced several regulatory, manufacturing and clinical initiatives during the first quarter of 2026, including progress toward potential approval of its preservative-free ketamine product, KETAFREE, and preparations for an NDA filing for NRX-100.

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.

NRx Pharmaceuticals, Inc. (NRXP) came out with a quarterly loss of $0.04 per share versus the Zacks Consensus Estimate of a loss of $0.05. This compares to a loss of $0.34 per share a year ago.

NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) will release earnings for its first quarter before the opening bell on Monday, May 18.

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.

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 facilities Company 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 and Drug Administration to initiate a clinical trial of NRX-101 (D-cycloserine/lurasidone fixed dose combination) vs.

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.

NRx has received a positive review letter (Discipline Review Letter) addressing Drug Quality requesting only “Minor” administrative changes NRx 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.

WILMINGTON, Del., April 20, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals (Nasdaq:NRXP) welcomes the newly-signed Executive Order: ACCELERATING MEDICAL TREATMENTS FOR SERIOUS MENTAL ILLNESS, signed by President Trump on April 18, 2026. In the Order, the President notes that, “It is the policy of my Administration to accelerate innovative research models and appropriate drug approvals to increase access to psychedelic drugs that could save lives and reverse the crisis of serious mental illness in America.”

Dr. Dennis K. McBride, PhD (CAPT, Medical Service Corps, US Navy, Ret.

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 Chief Commercial Officer. As NRx looks forward to the anticipated approval of its Abbreviated New Drug Application for their preservative-free ketamine product, it looks to build its commercial capabilities and prepare for a successful launch.

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.

SARASOTA, Fla. and PARIS, March 30, 2026 (GLOBE NEWSWIRE) -- Hope Therapeutics, Inc. (“Hope”), a subsidiary of NRx Pharmaceuticals, Inc. (Nasdaq: NRXP), today announced a strategic partnership with Emobot Health to deploy its revolutionary AI-driven emotional monitoring platform across Hope's rapidly expanding network of interventional psychiatry clinics. This roll-out represents the first large-scale clinical integration of Emobot's "Depression Thermometer," a passive monitoring tool designed to detect early treatment response and prevent relapse in patients with Treatment-Resistant Depression (TRD).

NRx Pharmaceuticals, Inc. (NRXP) Q4 2025 Earnings Call Transcript

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.

NRx Pharmaceuticals, Inc. (NRXP) came out with quarterly earnings of $0.19 per share, beating the Zacks Consensus Estimate of a loss of $0.09 per share. This compares to a loss of $0.3 per share a year ago.

NRx Pharmaceuticals, Inc. (NRXP) Shareholder/Analyst Call Prepared Remarks Transcript

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.

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.

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.

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.

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, PhD, as its Chief Medical Innovation Officer.

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 Evidence Based 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, Inc. (Nasdaq: NRXP), a clinical-stage biopharmaceutical company, today announced that it has completed an in-person Type C guidance meeting at the headquarters of the US Food and Drug Administration.

DRTS, MPC and NRXP have been added to the Zacks Rank #5 (Strong Sell) List on January 27th, 2026.

WILMINGTON, Del., Jan. 16, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (Nasdaq:NRXP) (the “Company”), a clinical-stage biopharmaceutical company, today announced that it will hold its annual meeting of stockholders (the “2025 Annual Meeting”) on March 23, 2026 at 10:00 a.m. Eastern Time, in virtual-only format at https://www.cstproxy.com/nrxpharma/2026, and any adjournments or postponements thereof. The Company's Board of Directors (the “Board”) also set a record date of February 12, 2026 entitling stockholders of record as of such date to notice of and to vote at the 2025 Annual Meeting.

WILMINGTON, Del., Jan. 14, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP), a clinical-stage biopharmaceutical company, today announced that it has licensed Real World Evidence (RWE) drawn from over 70,000 patients in the United States who were treated with either intravenous ketamine or nasal S-ketamine for depression and suicidal ideation. The information is being submitted in support of NRx's application for Accelerated Approval of NRX-100 (preservative-free ketamine) under Fast Track Designation for Treatment of Suicidal Ideation in Depression and Bipolar Depression. Currently, there is no medicine approved to treat suicidal ideation and the only FDA-approved treatment today is Electroshock Therapy.

WILMINGTON, Del. and MUNICH, Jan. 05, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP), a clinical-stage biopharmaceutical company and neurocare Group AG today (“The Partners”) announced a partnership to create a nationwide network of clinics to offer integrated neuroplastic care for the treatment of Depression, PTSD, and other serious mental health disorders. Pilot programs have shown that combining Transcranial Magnetic Stimulation (TMS) with ketamine and other neuroplastic drugs, along with hyperbaric oxygen therapy and supportive psychotherapy has resulted in a high rate of remission among First Responders with PTSD and Depression.

WILMINGTON, Del., Dec. 18, 2025 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP), a clinical-stage biopharmaceutical company, today announced that it has repaid the remaining $5.4 million balance sheet debt to Anson Funds, LLC, through equity conversion of common stock. There were no warrants or other repricing mechanisms associated with this transaction. Anson originally lent $16.2 million USD to the Company to fund repayment of prior loans and corporate operating expenses. With this repayment, the Company anticipates ending the 2025 calendar year with a balance sheet free of all debt. NRx believes that this milestone properly positions the company's capital structure for accelerated growth with anticipated drug approvals and clinic expansions in the coming year.

WILMINGTON, Del., Dec. 03, 2025 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP), a clinical-stage biopharmaceutical company, today announced that it has amended its Investigational New Drug filing for NRX-101 (D-cycloserine/lurasidone) to include the use of NRX-101 in association with Transcranial Magnetic Stimulation (TMS) for the treatment of depression, including suicidal depression.

NRx Pharmaceuticals, Inc. (NRXP) Discusses Regulatory Update and Development Pipeline Expansion for Preservative-Free Ketamine Formulation Transcript

WILMINGTON, Del., Dec. 02, 2025 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP), a clinical-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has received the Company's Abbreviated New Drug Application (ANDA) for KETAFREE™, a preservative-free intravenous ketamine formulation. The acknowledgement letter states that the FDA has “made a threshold determination that this ANDA is substantially complete” and issued a goal date of July 29, 2026 for completion of the final review with potential marketing approval.

WILMINGTON, Del., Dec. 02, 2025 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced that it will host a corporate update conference call on Tuesday, December 2, 2025 at 9:00am ET.

WILMINGTON, Del., Dec. 01, 2025 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP, the “Company”, “NRx”), a clinical-stage biopharmaceutical company and HOPE Therapeutics, an interventional psychiatry network owned by NRx, today announced that its Founder, Chairman, and Chief Executive Officer, Jonathan Javitt, M.D.

NRx Pharmaceuticals, Inc. ( NRXP ) Q3 2025 Earnings Call November 17, 2025 8:30 AM EST Company Participants Matthew Duffy - Chief Business Officer & Co-CEO of Hope Therapeutics Michael Abrams - Chief Financial Officer Jonathan Javitt - Co-Founder, Chief Scientist Officer, Chairman & Interim CEO Conference Call Participants Thomas Shrader - BTIG, LLC, Research Division Patrick Trucchio - H.C. Wainwright & Co, LLC, Research Division Edward Woo - Ascendiant Capital Markets LLC, Research Division Presentation Operator Good morning, ladies and gentlemen, and welcome to the NRx Pharmaceuticals' Q3 2025 Earnings Conference Call.

NRx has refiled its Abbreviated New Drug Application for KETAFREE™ (preservative free ketamine), received supportive correspondence from FDA, and expects Q2 2026 GDUFA date. HOPE Therapeutics is now operating three revenue-generating facilities in Florida and expects six or more by year-end providing neuroplastic drugs, transcranial magnetic stimulation, hyperbaric therapy, and digital therapeutics to treat suicidal depression and PTSD.

WILMINGTON, Del., Nov. 12, 2025 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced that it will release its third quarter 2025 financial results before the market opens on Monday, November 17, 2025 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 8:30am ET the same day.