New Hope
NASDAQ:NRXP
NRX-101 has the potential to offer the first ray of hope to patients with suicidal depression, potentially transforming NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) into a biotech blockbuster, with sales of $1 billion - $2 billion annually!
While NRx continues to develop NRX-101, it has already accumulated data proving that its ketamine product (NRX-100) is superior to placebo in reducing symptoms of suicidality and depression. Positive trials, funded by the US govt and the French govt with nearly 1,000 patients. The company has already been awarded FDA Fast Track designation for ketamine and has created a daughter company, HOPE Therapeutics is expected to initiate commercial distribution of the ketamine-based product, with an anticipated PDUFA date prior to December 31, 2025.
This biotech company an irresistible proposition, not to be overlooked.
Suicide kills >50,000 Americans every year
Disproportionately affecting people with Bipolar Disorder
As the journey toward transformative mental health solutions advances, NRx Pharmaceuticals (NASDAQ: NRXP) invites stakeholders to participate in a bold mission to address the urgent and growing crisis of suicidal depression.
At the heart of this mission is NRX-100, an intravenous ketamine formulation developed to offer rapid relief for individuals suffering from acute suicidality and depression. Positioned as a potential game-changer, NRX-100 stands out as a critical intervention for patients in crisis.
The Company has initiated the filing of a New Drug Application (NDA) with the U.S. FDA for NRX-100, targeting treatment for suicidal depression. In addition, the planned NDA filing for NRX-101—pursued under Accelerated Approval, Breakthrough Therapy Designation, and Priority Review—addresses bipolar depression in patients at risk of akathisia. Both filings have anticipated PDUFA dates before December 31, 2025.
Adding further depth to its pipeline, NRX-101, a breakthrough-designated therapy, is being developed for the treatment of suicidal, treatment-resistant bipolar depression and chronic pain. By combining D-Cycloserine (DCS) with lurasidone, NRX-101 represents a novel therapeutic strategy for those struggling with debilitating mental health conditions.
Significantly, the Company has accepted non-binding potential licensing terms with a commercial pharmaceutical partner for NRX-100, which could result in over $300 million in milestone payments, in addition to tiered double-digit royalties based on net sales.
As clinical progress continues, NRx Pharmaceuticals remains committed to redefining mental health treatment paradigms. Stakeholders are encouraged to take part in shaping a future where innovative therapeutics bring hope and healing to those most in need.
NRx Pharmaceuticals’ momentum from 2024 has carried into 2025, with advancement of regulatory filings for NRX-100 and NRX-101, alongside progress in expanding the Company’s commercial opportunity through potential new intellectual property protection for NRX-100, now complementing the Company’s already robust NMDA IP portfolio. Significant strides have also been made toward realizing the vision for HOPE Therapeutics as a national network of interventional psychiatry clinics—highlighted by announcements regarding the planned acquisitions of Kadima, Dura Medical, and Neurospa TMS.
These accomplishments demonstrate the team’s dedication to advancing mental health innovation and delivering life-saving treatments to patients in urgent need.
NRx Pharmaceuticals 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. The Company is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. NRx plans to file an NDA for Accelerated Approval for NRX-101 in patients with bipolar depression and suicidality or akathisia. NRX-101 additionally has potential as a treatment for complicated UTI.
NRx has recently initiated a New Drug Application filing for NRX-100 (preservative free IV ketamine) for 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.
NRx 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 and has filed a patent for this novel formulation with the US Patent and Trademark Office.
NRx brings hope:
Life-saving medicines
For people living with unmet medical needs.
NRx believe in a world where scientific advancement makes untreatable diseases treatable.
HOPE Therapeutics, an NRx Pharma daughter company, is developing NRX-100 (IV Ketamine) for treatment of Acute Suicidality and Depression.
Aiming to be the first FDA-approved ketamine product to treat suicidal depression>
Bipolar disorder is an illness that affects approximately 7 million individuals in the USA. It can cause notable changes in a person’s mood, energy and ability to think clearly.
People with bipolar disorder experience high and low moods—known as mania (highs) and depression (lows). These common, severe mood changes are different and generally much more pronounced than the mood changes most experience.
Patients with Bipolar Depression are 20-30x more likely to attempt suicide than the general population. Over the course of 5 years, 1 in 5 patients suffering from Bipolar Depression will attempt suicide. Estimates indicate that 11-20% of those with Bipolar Disorder succumb to suicide.
Chronic Pain is at the heart of the Opioid Crisis
Few new drugs are on the horizon
NRX-101 may offer hope
The current opioid crisis, fueled by a failure of non-opioid medication to achieve meaningful clinical relief, creates an acute need for nonaddictive, non-sedating pain medication.
New academic and pre-clinical research shows that NMDA receptors are active at each step of the pain pathway: From the focal point of our pain, through the peripheral nervous system, up our Spinal cord to the brain.
D-Cycloserine (DCS), an active ingredient of NRX-101, is a potent NMDA antagonist at high-enough doses. We are developing NRX-101 to treat chronic pain by modulating the NMDA receptor at every step of the pain pathway.
PTSD can happen to anyone. It is not a sign of weakness. A number of factors can increase the chance that someone will develop PTSD, many of which are not under that person’s control.
PTSD occurs after people go through, or witness, life-threatening events. These can be single, traumatic instances, or intense, long-lasting traumatic experiences. These include war and combat, sexual assault, disasters and mass violence.
Anyone can develop PTSD, and its not under a person’s control. PTSD is also more common after combat or sexual assault.
If you know five people with bipolar disorder, on average one will succumb to suicide. After centuries of mystery about the mechanism of bipolar disorder, major breakthroughs in unlocking the mystery began with Professor Daniel Javitt’s 1987 discovery that the NMDA receptor of the brain is the key to maintaining control over the rate at which thoughts are formed and the manner in which brain cells connect to one another.
Javitt’s work began with an attempt to explain the mechanism of drug-induced psychosis, a condition where people’s thoughts race out of control and hallucinations are common. Over the subsequent 25 years, it has become apparent that the NMDA receptor also has a major effect on depression and, particularly, thoughts of suicide. NRx is on a mission to bring hope to people who suffer from suicidal depression and PTSD through a new generation of NMDA-modulating medicines.
D-cycloserine, patented by Javitt as an antidepressant and antisuicidal drug, is approved worldwide as an anti-infective, primarily used for the treatment of tuberculosis. Although its anti-infective activity is based on its ability to disrupt bacterial cell walls, it also acts as an NMDA antagonist when used at high doses (> 500 mg). By targeting the NMDA receptor and modulating NMDA activity, D-cycloserine seems to foster a normal pace of thought generation. Multiple exploratory clinical studies have demonstrated that administration of D-cycloserine can trigger an antidepressant effect, as well as maintain a reduced level of suicidality.
Humankind is only at the dawn of understanding brain chemistry. The world’s most advanced computer lacks the creativity of a human brain. In part, that’s because electronic computers are completely binary in their logic circuits. Circuits are hard-wired to one another. Electrical connections are either on or off. The brain, however, is an analog computer in which both chemical and electrical signals modulate brain cells, which are constantly forming and breaking connections to one another.
Suicidal depression stands as a pervasive and urgent concern in our society, casting a shadow over the lives of millions worldwide. For those grappling with this debilitating condition, each day can feel like an insurmountable struggle, fraught with despair and hopelessness. Traditional treatment options often fall short, leaving many individuals trapped in a cycle of anguish with limited avenues for relief.
However, amidst the darkness, a beacon of hope emerges in the form of NRX-100 (IV Ketamine) from NRx Pharmaceuticals (Nasdaq: NRXP). This groundbreaking therapy offers a glimmer of light for those battling acute suicidal depression, providing a novel approach to intervention and potentially saving countless lives. With NRx Pharmaceuticals' innovative solutions and unwavering commitment to addressing mental health challenges, there is newfound optimism for a future where the grip of suicidal depression is loosened, and individuals find solace and healing.
In response to the pervasive problem of suicidal depression, NRx Pharmaceuticals (Nasdaq: NRXP) presents a groundbreaking solution: NRX-100 (IV Ketamine). This innovative therapy offers a ray of hope for individuals grappling with acute suicidal depression, providing a path towards healing and recovery.
NRX-100, developed by NRx Pharmaceuticals, represents a paradigm shift in the treatment landscape, offering a novel approach to addressing the profound challenges of suicidal depression. With its potential to provide rapid relief and alleviate symptoms, NRX-100 stands as a beacon of light in the darkness, offering renewed hope to those who have long struggled in silence.
Moreover, NRx Pharmaceuticals' dedication to advancing research and development in mental health extends beyond suicidal depression. With initiatives such as NRX-101 for chronic pain, D-Cycloserine (DCS) for PTSD, and NRX-101 for complicated UTI, the company is poised to revolutionize treatment across a spectrum of conditions, offering comprehensive solutions to complex challenges.
NRx is currently investigating our approach in FDA clinical trials. Results from our STABIL-B phase 2 study were presented at the American College of Neuropsychopharmacology in December 2018, and the FDA granted breakthrough therapy designation (BTD) to NRX-101 based on this study.
Results from NRx Pharma’s STABIL-B trial, a phase 2 study were presented at the American College of Neuropsychopharmacology in December 2018. The FDA granted breakthrough therapy designation (BTD) to NRX-101 based on this study.
A full, peer-reviewed report of the STABIL-B Trial is published in the International Journal of Bipolar Disorders and can be found here.
NRx Pharmaceuticals (Nasdaq: NRXP) is a clinical-stage biopharmaceutical company advancing innovative treatments for central nervous system disorders. Its lead assets, NRX-100 and NRX-101, target acute suicidal depression, PTSD, chronic pain, and complicated UTIs, with both therapies granted Fast Track Designation by the FDA.
NRX-100, a preservative-free IV ketamine, is designed to provide rapid relief for patients facing suicidal crises. NRX-101 continues to progress through pivotal trials, showing promise as a safer oral treatment alternative for bipolar depression and related conditions.
Through its subsidiary, HOPE Therapeutics, NRx is building a $100 million network of interventional psychiatry clinics across the U.S., integrating neuroplastic therapies like TMS and ketamine infusions.
With regulatory momentum, market validation, and a strong clinical pipeline, NRx Pharmaceuticals represents a high-impact investment opportunity.
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