• Developing NRX-101, an FDA-Designated Investigational Breakthrough Therapy for Suicidal Treatment-Resistant Bipolar Depression and Chronic Pain.

• Designed to Help Address the Needs of Over 13 Million Americans who Seriously Consider Suicide Each Year (CDC).

• D. Boral Analyst Report on NRXP $34 Price Target.

• Type C Meeting with the FDA Demonstrates a Path to New Drug Application with Real World Data and Broader Proposed Indication for NRX-100 (ketamine).

• Opening of Palm Beach, FL Clinic for One Day Treatment for Depression and PTSD, Now Accepting Patients.

• 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.

• Prof. Joshua Brown MD, PhD, Appointed as Chief Medical Innovation Officer.

• In-Person Meeting attended with FDA Division of Psychiatry Products and Leadership of the FDA Center for Drug Evaluation and Research (CDER).

• On Path to Application for New Drug Approval of NRX-100 Under Fast Track Designation Based on Existing Clinical Trial Data and Real World Evidence.

• NRXP Will Seek Broader Indication to Serve Patients with Treatment-Resistant Depression Who May Have Suicidality Rather Than the Subset with Suicidality.

• 70,000 Patient Data on Real World Use of Ketamine for Treatment of Suicidal Depression to be Submitted to the FDA in Support of NRX-100 Approval

• Analyses Suggested Clinical Response is Consistent with Prior Randomized Trial Data and Compares Favorably to Currently-Approved Products.

• NRXP and neurocare Group AG Announce Joint Offering of Neuroplastic Therapy Targeting Depression, PTSD and Other Mental Health Afflictions.

• Elimination of All Balance Sheet Debt Following Equity Conversion.

• New Pipeline Indication for Augmentation of Transcranial Magnetic Stimulation.

• Applied for Use of KETAFREE™ as a Proprietary Product Name as First Preservative-Free Ketamine Formulation.

• Current Worldwide Generic Ketamine Market Estimated at $750 Million Per Year.

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

NRXP has partnered with Alvogen Pharmaceuticals around the development and marketing of NRX-101 for the treatment of suicidal bipolar depression. NRX-101 additionally has potential to act as a non-opioid treatment for chronic pain, as well as a treatment for complicated UTI.

NRXP is working on a New Drug Application for NRX-100 (IV ketamine) in the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreement. NRXP was awarded Fast Track Designation for development of ketamine (NRX-100) by the US FDA as part of a protocol to treat patients with acute suicidality.

D. Boral has issued an Analyst Report on NRXP with a Buy and $34 Price Target. The full report may be accessed at this direct link: https://www.nrxpharma.com/wp-content/uploads/2025/11/HOPE-Therapeutics-NRXP-Executes-Florida-Roll-out-of-Ampa-O.pdf

Opening of Palm Beach, FL Clinic for One Day Treatment for Depression and PTSD, Now Accepting Patients

On March 9th NRXP announced the opening of its Palm Beach, FL clinic location dedicated to the treatment of Depression and PTSD with an interventional psychiatry approach that includes ketamine1 and other neuroplastic drugs, transcranial magnetic stimulation (TMS), and hyperbaric oxygen, combined with physician-led psychotherapy. This NRXP clinic location is the most recent addition to HOPE’s growing network of clinics.

Peer-reviewed scientific publications have shown an 87% clinical response rate with a short-term treatment protocol in patients with treatment-resistant depression. With the addition of hyperbaric oxygen therapy, NRXP pilot programs have shown a 90% rate of return to full function in patients with depression and post-traumatic stress disorder. TMS has also been shown in some studies to demonstrate improved memory and cognition in some patients with Alzheimer’s disease and Traumatic Brain Injury. NRXP previously announced a nationwide partnership with neurocare AG and expects to bring the latest developments in the non-invasive treatment of these conditions to this flagship location.

NRXP Appoints Prof. Joshua Brown MD, PhD, as Chief Medical Innovation Officer

On March 2nd NRXP announced that it has appointed Prof. Joshua C. Brown, MD, PhD, as its Chief Medical Innovation Officer. Prof. Brown is a pioneer in Transcranial Magnetic Stimulation (TMS) and serves as current President of the Clinical TMS Society and Editor-in-Chief of the Transcranial Magnetic Stimulation journal. He has an extensive publication history in the science of neuroplasticity and its relationship to healing depression and PTSD. Prof. Brown also has a unique background in charting a path for forward deployment of TMS with neuroplastic medication to treat depression and PTSD in military personnel, veterans, and first responders.

Path to New Drug Application with Real World Data and Broader Proposed Indication for NRX-100 (ketamine) Following Type C FDA Meeting

On February 17th NRXP announced that it has completed an in-person Type C guidance meeting, together with Osmind, Inc. at the headquarters of the US Food and Drug Administration. The meeting was attended by leaders of the FDA Division of Psychiatry Products, the FDA Office of Neuroscience, and the FDA Center for Drug Evaluation and Research.

Based on oral guidance received at the meeting, NRXP believes it has a path to filing an application for New Drug Approval of NRX-100 (preservative-free ketamine) based on Substantial Evidence of Effectiveness derived from existing data from adequate and well controlled trials together with confirmatory evidence from more than 65,000 patients identified in the Real World Evidence dataset. NRXP will additionally seek a broader indication to serve patients with treatment resistant depression in the context of suicidality, rather than only the subset of patients with suicidality.

The Companies will work collaboratively with the FDA in the coming weeks to finalize the statistical analysis protocol for the full 65,000 person Real World Evidence dataset under FDA’s newly published guidance.

In preliminary comments ahead of meeting, FDA advised NRXP that no additional nonclinical data would be required for review of the NRXP New Drug Application and that no bridging studies would be needed to support the NRXP preservative-free formulation compared to the currently-approved preservative-containing formulation of ketamine.

70,000 Patient Data on Real World Use of Ketamine for Treatment of Suicidal Depression to be Submitted to the FDA in Support of NRX-100 Approval

On January 14th NRXP 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 the NRXP 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.

A preliminary analysis of a 20,000 patient subset documented rapid resolution of depression and suicidality with initiation of intravenous ketamine. NRXP analyses suggested that clinical response to intravenous ketamine is consistent with prior randomized trial data and compares favorably to currently-approved products. Results from an upcoming analysis of the full 70,000 patient Real World Data set will be presented to the FDA in support of Accelerated Approval.

NRXP and neurocare Group AG Announce Joint Offering of Neuroplastic Therapy Targeting Depression, PTSD and Other Mental Health Afflictions

On January 5th NRXP announced a partnership with neurocare Group AG 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.

Recent scientific publications have demonstrated that integration of TMS with neuroplastic drugs has achieved unprecedented response of 87% and remission of 72% in patients with treatment-resistant depression. NRXP and neurocare are additionally exploring joint regulatory paths including clinical trials to address the treatment of Bipolar Depression, Autism, and Traumatic Brain Injury with TMS and neuroplastic drugs, such as NRX-101.

The NRXP program will integrate existing neurocare clinics with HOPE Therapeutics clinics and will engage the already-installed base of 400+ Apollo® Transcranial Magnetic Stimulation (TMS) machines nationwide.

Elimination of All Balance Sheet Debt Following Equity Conversion

On December 18th NRXP announced that its remaining $5.4 million debt was repaid through strategic equity conversion in common stock with no additional warrants or adjustment provisions. The debt-free balance sheet sets the stage for accelerated NRXP growth in 2026 with potential drug approvals and clinic expansions.

For more information on $NRXP visit: https://www.nrxpharma.com/ and https://compasslivemedia.com/case-study/nrx-pharmaceuticals/

Email: mduffy@nrxpharma.com

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Website: https://www.nrxpharma.com/