- Developing NRX-101, an FDA-Designated Investigational Breakthrough Therapy for Suicidal Treatment-Resistant Bipolar Depression and Chronic Pain.
- Designed to Help 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).
- Submitting a New Drug Application to Align the Labeling of Ketamine with its Use in Treating Depression and Suicidality.
- 2026 Q1 Financial Results Showed Significantly Improved Financial Status with Lower Net Loss vs Same Perion in 2025
- Response Made to Unfounded Public Statements Regarding Kadima Dispute.
- FDA Grant of Expanded Access Protocol for Use of D-Cycloserine-Based NRX-101 for Augmentation of Transcranial Magnetic Stimulation for Depression.
- Closed on $22.3 Million Public Offering of Common Stock and Including Exercise of the Underwriters’ Option.
- NRXP Subsidiary HOPE Therapeutics Becomes First Commercial Site to Deploy Zeta Surgical's FDA-Cleared Zeta TMS Navigation System
- AI-Powered, Sub-Millimetric Image Guidance for Delivery of Transcranial Magnetic Stimulation (TMS) to Patients.
- Initiated First Commercial Manufacturing for Preservative Free Ketamine.
- President Trump Signed Executive Order to Accelerate Treatments for Mental illness with Support for Psychedelic Medications.
- Robotic-Enabled Transcranial Magnetic Stimulation Combined with Neuroplastic Therapy for Military and First Responder Applications
- Anticipated FDA Approval of at Least One NRXP New Drug – Preservative Free Ketamine Under an ANDA—During Q3 2026.
- Clinical Leadership by Physicians Trained at Harvard, Johns Hopkins, Georgetown, and Other Leading Universities.
- 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.
- 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 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
Response to Public Statements Regarding Kadima Dispute
On June 25th NRXP issued the following statement in response to recent public claims made by Kadima Neuropsychiatry Institute.
Kadima issued a public statement making unfounded allegations related to the non-acquisition of Kadima by HOPE Therapeutics, Inc., a majority-owned subsidiary of NRXP. As disclosed in recent filings with the Securities and Exchange Commission, NRXP has compelled arbitration over Kadima’s failure to meet key closing conditions contemplated in the related transaction documents including, but not necessarily limited to, the delivery of clear title to Kadima’s assets and a material adverse change in the condition of the business.
Kadima signed a binding arbitration agreement and entered into active arbitration in which the parties clearly intended to separate from one another. Management believes that specific performance, whereby NRXP HOPE would acquire Kadima and retain Dr. Feifel as HOPE’s Chief Medical Innovation Officer, would not be in the best interests of either the patients or shareholders. Moreover, despite Kadima’s allegations, NRXP does not believe that the acquisition or non-acquisition of any individual clinic would be material to HOPE’s overall business model. Rather, the future success of NRXP depends on its ability to develop new drugs and medical technologies with national and international reach that deliver superior outcomes for patients affected by depression, PTSD and other serious medical conditions in need of care.
First Patients Treated with Zeta Surgical's FDA-Cleared Zeta TMS Navigation System
Om June 25th NRXP announced treating its first patients using Zeta Surgical's FDA-cleared Zeta TMS Navigation System. NRXP subsidiary HOPE Therapeutics has installed Zeta TMS Navigation Systems at its clinics in West Palm Beach and Sarasota, Florida, with Zeta-navigated patient treatments now underway at both locations.
Key points included:
First Zeta-navigated TMS treatments have begun at NRXP 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).
FDA Grant of Expanded Access Protocol for Use of D-Cycloserine-Based NRX-101 for Augmentation of Transcranial Magnetic Stimulation for Depression
On June 22nd NRXP announce 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 conditions.
Key points included:
D-Cycloserine (DCS) has been reported to augment the effect of Transcranial Magnetic Stimulation (TMS) in remission from depression and suicidality in published clinical studies.
NRXP 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.
Closing of $22.3 Million Public Offering of Common Stock and Including Exercise of the Underwriters’ Option
On June 4thNRXP announced the closing of its underwritten public offering of shares of its common stock, par value $0.001 per share at a public offering price of $3.50 per share.
The gross proceeds of the Offering were approximately $22.3 million before deducting underwriting discounts and commissions including exercise of the underwriters’ option to purchase additional shares of common stock. NRXP intends to use the net proceeds from the Offering for working capital and general corporate purposes to support its growth.
First Quarter 2026 Financial Results and Corporate Update
On May 18th NRXP announced financial results for the quarter ended March 31, 2026, and reviewed its latest key developments. The quarter was marked by continued progress advancing NRXP drug candidates toward commercialization, further development of the HOPE Therapeutics subsidiary, FDA acceptance of an IND for a federally-supported trial of NRX-101 as an adjunct to robotic Transcranial Magnetic Stimulation (TMS), and the pending acquisition of a Phase 2 monoclonal antibody portfolio targeting Human Endogenous Retroviruses (HERVs) implicated in Schizophrenia, Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), Autism, and Type 1 Diabetes.
For the quarter of 2026, NRXP reported an improved net loss of $1.4 million, versus a net loss of $5.5 million during the comparable quarter in 2025.
Highlights from the first quarter included:
Anticipated FDA decision on NRXP 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 NRXP 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.
Completed a Type C meeting with the FDA Division of Psychiatry Products and CDER leadership, in which the Agency expressed openness to existing clinical trial data and Real World Evidence supporting approval without additional trials.
FDA acceptance of an Investigational New Drug (IND) application for NRXP NRX-101 as an adjunct to robotic-enabled Transcranial Magnetic Stimulation (TMS), with anticipated non-dilutive federal funding supporting study at military and civilian sites.
Development of a patentable, sustained-release formulation of D-cycloserine designed to enhance TMS efficacy, building on prior trial data showing a doubling of clinical response and 8-fold increase in remission versus standard TMS.
First revenue generated from five NRXP interventional psychiatry clinics treating severe depression and PTSD, with funding from the VA, Department of War, private insurers, and self-pay; footprint expected to expand meaningfully in 2026.
Presidential Initiative to Accelerate Approval of Psychedelic Medications to Treat Depression, PTSD, and Suicidality
On April 20th NRXP welcomed the 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.”
The order directs the Commissioner of the US Food and Drug Administration to provide Commissioner’s National Priority Vouchers (CNPV) to appropriate psychedelic drugs that have received a Breakthrough Therapy designation and are in accordance with the criteria of the National Priority Voucher Program. NRXP has applied for a CNPV in support of its upcoming New Drug Application for NRX-100.
For more information on $NRXP visit: https://www.nrxpharma.com/ and https://compasslivemedia.com/case-study/nrx-pharmaceuticals/
Media Contact Company Name: NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) Contact Person: Brian Korb, Managing Partner, astr partners Email: brian.korb@astrpartners.com Phone: (917) 653-5122 Country: United States
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