NRX Pharmaceuticals, Inc. - Common Stock (NRXP)

NRx Pharmaceuticals, Inc. (Nasdaq: NRXP ) is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain and PTSD. NRXP is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain

NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, said it amended its Investigational New Drug filing for NRX-101 to include use of the drug in combination with Transcranial Magnetic Stimulation for depression, including suicidal depression. The update follows evidence suggesting NRX-101 may significantly enhance TMS outcomes, with published studies showing more than two-fold improvements in symptom reduction and clinical response rates exceeding 80%. The Company noted NRX-101’s D-cycloserine component appears to augment neuroplasticity associated with TMS, while its low-dose lurasidone is intended to mitigate D-cycloserine’s known risk of low-grade hallucinations. NRx said it aims to validate the findings in a well-controlled trial of about 120 participants and is in partnership discussions with TMS device manufacturers to pursue joint registration studies and potential label augmentation.

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. (Nasdaq: NRXP ) is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain and PTSD. NRXP is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain.

NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, said the FDA has received its Abbreviated New Drug Application for KETAFREE(TM), a preservative-free intravenous ketamine formulation, deeming the submission “substantially complete” and assigning a July 29, 2026 review goal date. CEO Jonathan Javitt said KETAFREE is designed to provide a single-patient, preservative-free alternative to current multidose ketamine vials that contain Benzethonium Chloride, a compound no longer recognized as safe by the FDA. The Company said KETAFREE aligns with MAHA initiatives to remove toxic substances from medicines and supports domestic supply-chain priorities, with potential 2026 approved drug sales if approved on schedule. NRx noted the program is separate from NRX-100, its Fast Track-designated treatment for suicidal depression, and said it continues to advance its broader pipeline and HOPE Therapeutics clinics.

NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, said it will host a corporate update conference call on Dec. 2, 2025, at 9 a.m. Eastern to review recent clinical, regulatory and operational developments.

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.

NRx Pharmaceuticals (NASDAQ: NRXP) said Founder, Chairman and CEO Jonathan Javitt, M.D., M.P.H., will present at NobleCon21 on Dec. 3 at 4:30 p.m. EST, offering an update on the company’s expanded focus in investigational drugs, medical devices, and interventional psychiatric therapies for suicidal depression, PTSD, and related conditions, as well as progress in generating clinical revenue since NobleCon 2024.

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., M.P.H will present at NobleCon21 - Noble Capital Markets’ Twenty First Annual Emerging Growth Equity Conference at Florida Atlantic University, Executive Education Complex, in Boca Raton, FL.- on Wednesday, December 3rd at 4:30 PM EST.

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NRx Pharmaceuticals, Inc. (Nasdaq: NRXP ) is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain and PTSD. NRXP is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain

NRx Pharmaceuticals (NASDAQ: NRXP) reported third-quarter 2025 results and outlined progress across its clinical programs, noting its first revenue-generating activities and key regulatory milestones for NRX-100 and NRX-101. The Company highlighted expanded Fast Track status and an active Expanded Access program for NRX-100 in suicidal depression, continued advancement of its NDA supported by large-scale real-world ketamine data, and an ANDA pathway for its preservative-free ketamine KETAFREE that remains on track for a Q2 2026 GDUFA date. NRx also noted FDA communication with no major deficiencies in its revised ANDA filing and ongoing efforts to remove benzethonium chloride from commercial ketamine formulations. For NRX-101, the Company initiated its NDA with Breakthrough Therapy Designation and rolling review, supported by real-world evidence showing that D-cycloserine more than doubles the antidepressant and antisuicidal effect of TMS. A confirmatory phase 3 trial is slated for early 2026, and the Company continues expanding its HOPE delivery platform with additional facilities planned in Florida.

WILMINGTON, Del., Nov. 17, 2025 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (“NRx Pharmaceuticals,” the “Company”), a clinical-stage biopharmaceutical company, today announced financial results for the quarter ended September 30, 2025, and provided a corporate update.

NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, announced it will release its third quarter 2025 financial results before market open on Monday, Nov. 17, 2025, followed by a conference call at 8:30 a.m. ET to discuss corporate, financial, and operational updates.

NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, announced it will release its third quarter 2025 financial results before market open on Monday, Nov. 17, 2025, followed by a conference call at 8:30 a.m. ET to discuss corporate, financial, and operational updates.

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.

NRx Pharmaceuticals, Inc. (Nasdaq: NRXP ) is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain and PTSD. NRXP is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain

NRx Pharmaceuticals (NASDAQ: NRXP), announced that its subsidiary, HOPE Therapeutics(TM), has initiated patient care using the Ampa “one day” (ONE-D) protocol for treatment-resistant depression—the first deployment of its kind in Florida and among the first nationwide. The Ampa device combines a single day of transcranial magnetic stimulation (TMS) with physician-prescribed D-cycloserine and lisdexamfetamine, which in peer-reviewed studies have shown response rates of 87% and remission rates of 72% in nonrandomized trials. Under the direction of Medical Director Dr. Rebecca Cohen, HOPE clinics in Sarasota, Naples, and Fort Myers are now offering the protocol, with six Florida locations expected by year-end. Dr. Cohen said the results “have the potential to change the paradigm of TMS therapy” from months-long regimens to a rapid, one-day approach that may transform care for millions battling depression and PTSD.

SARASOTA, Fla., Nov. 10, 2025 (GLOBE NEWSWIRE) -- HOPE Therapeutics™, Inc. ("HOPE"), an interventional psychiatry network owned by NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) today announced initiation of patient care with for treatment-resistant depression with the Ampa one day (ONE-D) protocol. HOPE is the first to deploy the Ampa technology in Florida and one of the first deployments nationwide. The Ampa device differs from other Transcranial Magnetic Stimulation (TMS) treatments in that the peer-reviewed literature has reported a high rate of success (87% response and 72% remission) in nonrandomized trials when a single day of TMS treatment is combined with physician-prescribed D-cycloserine and lisdexamfetamine (note that neither of the drugs reported in the published results is FDA-approved for the stated indication).1 D-cycloserine was previously reported to substantially enhance the effectiveness of TMS in reducing depression and suicidality by more than two-fold in a placebo-controlled trial using a traditional TMS protocol.2   Additional supportive findings documenting the effect of D-cycloserine in enhancing the effect of TMS were recently published by a team of researchers led by Prof. Joshua Brown at Harvard’s McLean hospital.3 Dr. Brown additionally serves as the President of the Clinical TMS Society.

NRx Pharmaceuticals (NASDAQ: NRXP) was featured in a recent article that discussed its approach to bring preservative-free ketamine-based therapies to market, pursuing distinct regulatory and commercial pathways for both KETAFREE(TM) and NRX-100. “The company recently refiled an Abbreviated New Drug Application (‘ANDA’) for KETAFREE(TM), a preservative-free intravenous (‘IV’) ketamine formulation intended for all currently approved ketamine indications,” the article reads. “This filing follows the U.S. Food and Drug Administration’s approval of NRx’s Suitability Petition to eliminate benzethonium chloride (‘BZT’), a chemical preservative still found in many ketamine formulations. BZT, a quaternary ammonium compound, has been associated with cytotoxic and neurotoxic effects. It is no longer considered Generally Recognized as Safe and Effective (‘GRASE’) for parenteral or topical pharmaceutical use. The European Medicines Agency has already discouraged its use in injectable drugs, and the FDA previously removed it from topical antiseptics and hand cleansers over safety concerns… By developing KETAFREE(TM), NRx aims to provide a safer and fully compliant version of ketamine for both hospital and outpatient use, at a time when supply constraints and rising demand have challenged healthcare providers… Alongside the ANDA pathway for KETAFREE(TM), NRx is advancing NRX-100, a separate preservative-free ketamine product, under a New Drug Application (‘NDA’) for the treatment of suicidal depression, including bipolar depression. The formulation has been granted Fast Track Designation by the FDA, positioning it for potential expedited review.”

MIAMI, Oct. 20, 2025 (GLOBE NEWSWIRE) -- HOPE Therapeutics™, Inc. ("HOPE"), an interventional psychiatry network owned by NRx Pharmaceuticals, Inc. (NASDAQ: NRXP), today announced the acquisition of a strategic interest in Cohen and Associates, LLC (“Cohen, LLC”) and its incorporation into the HOPE Network. Additionally, Rebecca Cohen, MD has joined HOPE as Medical Director, overseeing medical standards of care throughout HOPE’s Florida locations.

NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, recently secured approval from the U.S. Food and Drug Administration (“FDA”) for its Suitability Petition to advance KETAFREE(TM), a preservative-free version of ketamine. “The ruling allows the company to re-file its Abbreviated New Drug Application (‘ANDA’) for the product, which it has now done, a key step in bringing it to market,” reads a recent article. “Currently, ketamine is sold in multidose vials that require preservatives to maintain sterility after repeated use. The most common additive, Benzethonium Chloride, is known to be toxic. NRx’s proposed alternative eliminates preservatives by using single-patient dosing, a change the company argues improves safety and aligns with updated public health priorities… Beyond KETAFREE(TM), NRx continues to build out a pipeline of therapies focused on central nervous system disorders. Its preservative-free intravenous formulation NRX-100 has received Fast Track Designation for the treatment of suicidal depression, including bipolar depression. A related program, NRX-101, has earned Breakthrough Therapy Designation for suicidal bipolar depression. These programs complement the KETAFREE(TM) initiative, underscoring the company’s emphasis on addressing urgent psychiatric needs.”

NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, is advancing a two-pronged approach to bring preservative-free ketamine-based therapies to market, pursuing distinct regulatory and commercial pathways for both KETAFREE(TM) and NRX-100. ( https://ibn.fm/BYg97 ). The company recently refiled an Abbreviated New Drug Application (“ANDA”) for KETAFREE(TM), a preservative-free intravenous (“IV”) ketamine formulation intended for all currently approved ketamine indications.

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