Cycloserine

In advance of November 10, 2026 GDUFA goal date, three commercial lots of Preservative-Free Ketamine have been successfully manufactured in compliance with “Process Validation” required under FDA “Good Manufacturing Practices” (GMP). NRx has additionally received two year stability data consistent with projected room-temperature stability to three years and beyond with no need for toxic preservatives. Commercially-releasable drug supply is now on hand pending ANDA approval for this drug-shortage product. WILMINGTON, N.C., Oct. 19, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP, “NRx” or “the Company”), a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA receptor platform for the treatment of central nervous system disorders, today announces completion of three Process Validation lots of preservative free Ketamine produced under commercial conditions in anticipation of the November 10 GDUFA (Generic Drug User Fee Amendments) Goal Date. Process Validation 1 is the final step in the drug manufacturing process required to demonstrate compliance with FDA Good Manufacturing Practices (GMP). In related developments, NRx has now completed analysis of two-year room temperature real-time stability data on preservative-free ketamine demonstrating no deterioration in purity, potency, or sterility without the need for toxic preservatives. The Company believes that these data will be consistent with a labeled shelf life of three years or longer. “Completing Process Validation and reaching two years of room-temperature stability puts NRx in position to supply this drug-shortage product the moment the FDA approves our ANDA,” said Jonathan Javitt, MD, MPH, the Company’s Chairman and CEO. “We thank our partners at Nephron Pharmaceuticals in West Columbia, South Carolina, for helping us show that sterile, preservative-free injectables can be made in America, and we look forward to supplying American hospitals and clinics.” About NRx Pharmaceuticals, Inc. NRx Pharmaceuticals, Inc. ( ), is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA receptor platform for the treatment of central nervous system disorders, specifically suicidal depression, chronic pain, and PTSD. The Company is developing NRX-100 (preservative-free intravenous ketamine) and NRX-101, (oral D-cycloserine/lurasidone). NRX-100 has been awarded Fast Track Designation for the treatment of Suicidal ideation in Depression, including Bipolar Depression. NRX-101 has been awarded Breakthrough Therapy Designation for the treatment of suicidal bipolar depression. NRx has filed an Abbreviated New Drug Application (ANDA) and initiated a New Drug Application filing for NRX-100 for the treatment of suicidal ideation in patients with depression, including bipolar depression. Notice Regarding Forward-Looking Statements The information contained herein includes forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "plan," "believe," "intend," "look forward," and other similar expressions among others. These statements relate to future events or to the Company's future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. The Company has reported regulatory milestones as they have been achieved but has not predicted the outcome of any future regulatory determination. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects the Company's current views with respect to future events and is subject to these and other risks, including uncertainties and assumptions relating to the Company's operations, results of operations, growth strategy, and, among other things, liquidity. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's most recent Annual Report on Form 10-K and other filings with the Securities and Exchange Commission. Investors and security holders are urged to read these documents free of charge on the SEC's website at . Except as may be required by applicable law, the Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, whether as a result of new information, future events or otherwise. For further information: Brian Korb Managing Partner, astr partners (917) 653-5122 brian.korb@astrpartners.com 1

ONE-BD case series reports promising preliminary outcomes from an innovative single-day TMS regimen for adults with bipolar I depression PLANO, Texas, Oct. 15, 2026 /PRNewswire/ -- Salience TMS Neuro Solutions is proud to announce the publication of new research examining an innovative approach to transcranial magnetic stimulation (TMS) for bipolar depression that delivers an entire course of treatment in a single day. TMS therapy is a non-invasive treatment that uses magnetic stimulation to target specific areas of the brain involved in mood. TMS systems have received FDA clearance for the treatment of major depressive disorder, anxious depression, and obsessive-compulsive disorder (OCD). Continue Reading Take a look at TMS Therapy at Salience. Speed Speed The research paper, "Real-world effectiveness of a single-day course of transcranial magnetic stimulation using an Optimized, Neuroplasticity-Enhanced regimen in Bipolar Depression (ONE-BD)," was published in Transcranial Magnetic Stimulation, the journal of the Clinical TMS Society. This report represents a collaborative effort involving investigators from Salience and research partners including Ampa Health, a Palo-Alto-based neurotechnology company building a new generation of advanced TMS systems. Bipolar depression can present significant treatment challenges, with conventional medications and psychotherapy being ineffective for many people. Yet a new generation of 'interventional psychiatry' treatments such as TMS hold the potential to succeed where conventional treatments have failed. The ONE-BD case series explored whether a single day approach could potentially reduce one of the practical barriers associated with treatment: time. Conventional TMS treatment is typically delivered through a course of once daily treatment sessions over a period of several weeks. In single-day TMS, all of the sessions are delivered at carefully spaced intervals. The ONE-BD researchers investigated a substantially accelerated approach while monitoring participants over the following weeks. The ONE-BD case series reported on treatment outcomes for 30 adults with bipolar I disorder experiencing a current depressive episode. Each patient received 20 sessions of TMS over the course of a single day, with sessions lasting 3 minutes each, and spaced approximately 20 minutes apart. Patients also received a single dose of a medication called D-cycloserine, which had been shown in previous research to enhance the treatment effects for TMS in treating other disorders. All 30 participants completed the treatment regimen. Researchers reported no serious adverse events and no switches to mania or hypomania. Patients were followed for 12 weeks, with improvements in depression symptoms observed over the weeks following treatment. At six weeks, 73.3% of patients met criteria for response and 43.3% met criteria for remission based on the 17-item Hamilton Depression Rating Scale (HDRS-17). The patients' self-rated measures of mood symptoms also showed similar patterns of improvement. The researchers characterize the findings as preliminary and note that randomized controlled studies are needed to further evaluate the approach. "Our goal is not only to provide exceptional care today, but also to participate in research that asks important questions about how treatment can continue to improve for patients in the future," said Dr. Nancy Donachie, Chief Medical Officer at Salience. For Salience, the research reflects a broader commitment to advancing the science of TMS and expanding access to safe, evidence-based treatment options for people living with treatment resistant depression and other mental health conditions. Through continued research, clinical innovation and education, Salience is working to deepen the understanding of how TMS can be used today and explore its potential to help more patients in the future. Read the full open-access study:Here To learn more on our website about ONE-BD, click here About Salience TMS Neuro Solutions Salience TMS Neuro Solutions is dedicated to advancing mental healthcare through access to TMS therapy, clinical expertise, and continued research and innovation. Since 2011, Salience has delivered more than one million TMS treatments, building extensive experience in the use of neuromodulation to help patients struggling with mental health conditions. Media Contact Salience TMS Solutions [email protected] SOURCE Salience TMS Neuro Solutions 21% more press release views with Request a Demo