Trending...
- From Survival to Stability: Inspiring Safe Haven Is Transforming Lives Across South Jersey
- Igniting High-Growth Transformation With Launch of XMax AI Subsidiary, Leveraging Global Furniture Dominance to Enter Explosive AI Markets: XMax Inc
- You Are Not Broken: "I Am Unique" Is Transforming Women's Lives Through Healing, S
NRx Pharmaceuticals, Inc. (Stock Symbol: NRXP) $NRXP Set Up for $300 Million in Milestones on Tiered Double-Digit Royalties
MIAMI - JerseyDesk -- Developing NRX-101, an FDA-Designated Investigational Breakthrough Therapy for Suicidal Treatment-Resistant Bipolar Depression and Chronic Pain.
Aiming to be the First FDA-Approved Medication to Treat Suicidal Depression
Designed to Help Address the Needs of Over 13 Million Americans who Seriously Consider Suicide Each Year (CDC).
Agreement to Purchase Kadima Neuropsychiatry Institute Expected to Serve as Clinical Model for Treatment Offerings Nationwide.
Kadima is a Leading Investigative Site for CNS and Psychedelic Research, Having Served as the Lead Site in Nearly All Major Trials in This Space.
Dr. David Feifel, Nationally Recognized Pioneer in Interventional Psychiatry to join as Chief Medical Innovation Officer.
New Drug Application for Treatment of Suicidal Depression; Planned NDA for Accelerated Approval for Bipolar Depression in People at Risk of Akathisia.
Patent Application Filed for NRX-100 Proprietary, Preservative Free Formulation of IV Ketamine. Patent expected to be Orange Book Listable.
Waiver Exemption from Paying a $4.3 Million New Drug Application Fee Under Prescription Drug User Fee Act (PDUFA).
Company On Track for Q2 2025 Completion of NDA Filing and PDUFA Date by Year End with Currently Available Resources.
Term Sheet Signed for $2.5 Million Strategic Investment from a Global Medical Device Manufacturer into NRXP Subsidiary HOPE Therapeutics.
Accepted Non-Binding Potential Terms to License and Distribute NRX-100 Drug Providing Over $300 Million in Milestones Plus Tiered Double-Digit Royalties.
Poised to Address Over $3 Billion Suicidal Depression Market in the US.
Application to Uplist to Global Market
NRx Pharmaceuticals, Inc. (Stock Symbol: 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.
More on Jersey Desk
Intravenous ketamine is widely accepted as a standard of care for acute treatment of suicidal depression, in the absence of an FDA-labeled product; the only treatment currently approved by the FDA is electroconvulsive therapy (ECT). According to the CDC, 3.8 million Americans make a plan for suicide each year. This represents a $3-5 billion market at expected pricing. Based on the data in the trials referenced above, the Company's regulatory counsel encouraged the Company to file an NDA for suicidal depression for NRX-100.
In a January 2025 report, respected investment analysis firm D. Boral Capital assigned NRXP a $31 Price Target. The full report may be viewed at this link: https://www.nrxpharma.com/wp-content/uploads/2025/01/HOPE-Therapeutics-Advances-With-Kadima.pdf.
Agreement to Purchase Kadima Neuropsychiatry Institute; Foundational Acquisition for the NRXP HOPE Network of Interventional Psychiatry Clinics
On May 13th NRXP announced signing of a definitive agreement to purchase the Kadima Neuropsychiatry Institute. Kadima is expected to serve as the clinical model for treatment offerings in NRXP HOPE-acquired clinics and is expected to continue its role as a leading investigative site for research into neuroplastic therapies including psychedelic medications, transcranial magnetic stimulation (TMS), and hyperbaric therapy.
Kadima is one of California's flagship interventional psychiatry clinics and was among the first to bring ketamine treatment for central nervous system (CNS) disorders out of academic research settings and into clinical practice. The clinic offers a full range of treatments for suicidal depression, PTSD and other CNS disorders, including ketamine, Spravato, transcranial magnetic stimulation ("TMS") as well as medication management. Further, Kadima and David Feifel, MD PhD, Founder and Medical Director of Kadima, have served as leaders in clinical trial work on emerging therapies in CNS for top companies in the industry. Importantly, the clinic is profitable and is forecast to continue growth going forward. Dr. Feifel will join NRXP HOPE as its first Chief Medical Innovation Officer upon closing of the acquisition.
Patent Application Filed for NRX-100 Proprietary, Preservative Free Formulation of IV Ketamine
On May 5th NRXP announced the filing of a patent application for NRX-100, its preservative-free intravenous ketamine formulation for the treatment of suicidal depression. The application discloses pharmaceutical compositions, methods of treatment and methods of manufacture and currently includes twenty claims. While subject to the patent review process of the US Patent and Trademark Office, if granted, the patent would provide NRX-100 exclusivity into 2045.
This patent filing builds on the NRXP recently initiated filing of an NDA for NRX-100 and its prior Fast Track Designation, with NRX-101, from the FDA. If granted, the patent will help protect the innovation behind this formulation as NRXP advances its commercialization strategy.
More on Jersey Desk
"We are committed to delivering safer, more effective treatments for patients with suicidal depression," said Jonathan Javitt MD MPH, CEO of NRXP. "NRX-100 eliminates the need for benzethonium chloride, a compound with well-documented safety concerns, and reflects our belief that patients in crisis deserve therapies formulated with their long-term well-being in mind. With the recent FDA fee waiver now in place, we remain on track to complete our NDA submission this quarter — a critical step toward bringing this innovation to patients in need."
FDA Award of Filing Fee Waiver for Upcoming NRX-100 (preservative free ketamine) New Drug Application to Treat Patients with Suicidal Depression
On April 30th NRXP announced the grant of a filing fee waiver by the US Food and Drug Administration ("FDA") to exempt the Company from a $4.3 million fee to file its New Drug Application for NRX-100 (preservative-free ketamine). The waiver is granted at the discretion of the FDA to Small Business Entities and for drugs that are deemed to be necessary for Public Health. NRXP anticipates that this waiver enables the completion of its New Drug Application for NRX-100 with currently-available corporate resources. The NDA filing is anticipated by the end of the second quarter of this year (Q2 2025).
NRXP notes recent statements by the Secretary of Health and Human Services supporting the importance of psychedelic drugs to treat severe depression and PTSD. Ketamine is believed to have a beneficial effect through its role in blocking the NMDA receptor of the brain and causing increased levels of beneficial neurotransmitters in the brain, with resulting formation of new brain cell connections (synapses).
Term Sheet for Strategic Investment from a Global Medical Device Manufacturer into NRXP Subsidiary HOPE Therapeutics
On April 3rd NRXP announced signing of a term sheet with a global medical device manufacturer, as anticipated in the Company's recently filed annual report. The investor shares NRXP subsidiary HOPE's vision of providing comprehensive interventional psychiatry treatments to patients around the world. This Investment is intended to support initiation of HOPE's network of clinics to treat suicidal depression and PTSD with ketamine, TMS and other modalities.
The Term Sheet, which is non-binding and subject to the execution of a definitive Stock Purchase Agreement, contemplates an investment of $2.5 million to purchase Series A Convertible Preferred Stock at a $50 million pre-money valuation. This investment, together with expected bank financing and current balance sheet assets, is anticipated to close concurrent with, and in support of, the closing of HOPE's recently announced clinic acquisitions.
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. ((Stock Symbol: NRXP)
Contact Person: Matthew Duffy, Chief Business Officer
Company Website: https://www.nrxpharma.com/
Email: mduffy@nrxpharma.com
Phone: (484) 254-6134
Home Country: United States
DISCLAIMER: https://corporateads.com/disclaimer/
Disclosure listed on the CorporateAds website
Aiming to be the First FDA-Approved Medication to Treat Suicidal Depression
Designed to Help Address the Needs of Over 13 Million Americans who Seriously Consider Suicide Each Year (CDC).
Agreement to Purchase Kadima Neuropsychiatry Institute Expected to Serve as Clinical Model for Treatment Offerings Nationwide.
Kadima is a Leading Investigative Site for CNS and Psychedelic Research, Having Served as the Lead Site in Nearly All Major Trials in This Space.
Dr. David Feifel, Nationally Recognized Pioneer in Interventional Psychiatry to join as Chief Medical Innovation Officer.
New Drug Application for Treatment of Suicidal Depression; Planned NDA for Accelerated Approval for Bipolar Depression in People at Risk of Akathisia.
Patent Application Filed for NRX-100 Proprietary, Preservative Free Formulation of IV Ketamine. Patent expected to be Orange Book Listable.
Waiver Exemption from Paying a $4.3 Million New Drug Application Fee Under Prescription Drug User Fee Act (PDUFA).
Company On Track for Q2 2025 Completion of NDA Filing and PDUFA Date by Year End with Currently Available Resources.
Term Sheet Signed for $2.5 Million Strategic Investment from a Global Medical Device Manufacturer into NRXP Subsidiary HOPE Therapeutics.
Accepted Non-Binding Potential Terms to License and Distribute NRX-100 Drug Providing Over $300 Million in Milestones Plus Tiered Double-Digit Royalties.
Poised to Address Over $3 Billion Suicidal Depression Market in the US.
Application to Uplist to Global Market
NRx Pharmaceuticals, Inc. (Stock Symbol: 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.
More on Jersey Desk
- East Madison Dental Introduces Advanced Dental Implant in Englewood, NJ to Restore Confident Smiles
- Clash of Prompts: The World's First AI Prompt Battle Royale
- $7.6 Billion US Crypto ATM Market by 2034; California and Texas Crypto ATM Deployments for Bitcoin Bancorp (Stock Symbol: BCBC); 1000 Kiosk Inventory
- MainConcept Announces Multiview Encoding for Apple Immersive Video
- CCHR Rejects Global Psychiatric Push to Electroshock Children
Intravenous ketamine is widely accepted as a standard of care for acute treatment of suicidal depression, in the absence of an FDA-labeled product; the only treatment currently approved by the FDA is electroconvulsive therapy (ECT). According to the CDC, 3.8 million Americans make a plan for suicide each year. This represents a $3-5 billion market at expected pricing. Based on the data in the trials referenced above, the Company's regulatory counsel encouraged the Company to file an NDA for suicidal depression for NRX-100.
In a January 2025 report, respected investment analysis firm D. Boral Capital assigned NRXP a $31 Price Target. The full report may be viewed at this link: https://www.nrxpharma.com/wp-content/uploads/2025/01/HOPE-Therapeutics-Advances-With-Kadima.pdf.
Agreement to Purchase Kadima Neuropsychiatry Institute; Foundational Acquisition for the NRXP HOPE Network of Interventional Psychiatry Clinics
On May 13th NRXP announced signing of a definitive agreement to purchase the Kadima Neuropsychiatry Institute. Kadima is expected to serve as the clinical model for treatment offerings in NRXP HOPE-acquired clinics and is expected to continue its role as a leading investigative site for research into neuroplastic therapies including psychedelic medications, transcranial magnetic stimulation (TMS), and hyperbaric therapy.
Kadima is one of California's flagship interventional psychiatry clinics and was among the first to bring ketamine treatment for central nervous system (CNS) disorders out of academic research settings and into clinical practice. The clinic offers a full range of treatments for suicidal depression, PTSD and other CNS disorders, including ketamine, Spravato, transcranial magnetic stimulation ("TMS") as well as medication management. Further, Kadima and David Feifel, MD PhD, Founder and Medical Director of Kadima, have served as leaders in clinical trial work on emerging therapies in CNS for top companies in the industry. Importantly, the clinic is profitable and is forecast to continue growth going forward. Dr. Feifel will join NRXP HOPE as its first Chief Medical Innovation Officer upon closing of the acquisition.
Patent Application Filed for NRX-100 Proprietary, Preservative Free Formulation of IV Ketamine
On May 5th NRXP announced the filing of a patent application for NRX-100, its preservative-free intravenous ketamine formulation for the treatment of suicidal depression. The application discloses pharmaceutical compositions, methods of treatment and methods of manufacture and currently includes twenty claims. While subject to the patent review process of the US Patent and Trademark Office, if granted, the patent would provide NRX-100 exclusivity into 2045.
This patent filing builds on the NRXP recently initiated filing of an NDA for NRX-100 and its prior Fast Track Designation, with NRX-101, from the FDA. If granted, the patent will help protect the innovation behind this formulation as NRXP advances its commercialization strategy.
More on Jersey Desk
- iVAM2-ST2110 to Simplify IP Transitions and Reduce Monitoring Complexity
- Americans Leave Behind or Discard 42% of Their Belongings When Moving Out for the First Time, Talker Research Finds
- Central Florida Luxury Real Estate Firm DANHOLM COLLECTION Partners with Luxury Presence to Expand Global Buyer Reach
- HOPE Sheds Light Announces 6th Annual Golf Outing at New Location
- Advantage Marketing Launches 3-Minute Assessment to Help SMBs Diagnose and Fix Marketing Gaps
"We are committed to delivering safer, more effective treatments for patients with suicidal depression," said Jonathan Javitt MD MPH, CEO of NRXP. "NRX-100 eliminates the need for benzethonium chloride, a compound with well-documented safety concerns, and reflects our belief that patients in crisis deserve therapies formulated with their long-term well-being in mind. With the recent FDA fee waiver now in place, we remain on track to complete our NDA submission this quarter — a critical step toward bringing this innovation to patients in need."
FDA Award of Filing Fee Waiver for Upcoming NRX-100 (preservative free ketamine) New Drug Application to Treat Patients with Suicidal Depression
On April 30th NRXP announced the grant of a filing fee waiver by the US Food and Drug Administration ("FDA") to exempt the Company from a $4.3 million fee to file its New Drug Application for NRX-100 (preservative-free ketamine). The waiver is granted at the discretion of the FDA to Small Business Entities and for drugs that are deemed to be necessary for Public Health. NRXP anticipates that this waiver enables the completion of its New Drug Application for NRX-100 with currently-available corporate resources. The NDA filing is anticipated by the end of the second quarter of this year (Q2 2025).
NRXP notes recent statements by the Secretary of Health and Human Services supporting the importance of psychedelic drugs to treat severe depression and PTSD. Ketamine is believed to have a beneficial effect through its role in blocking the NMDA receptor of the brain and causing increased levels of beneficial neurotransmitters in the brain, with resulting formation of new brain cell connections (synapses).
Term Sheet for Strategic Investment from a Global Medical Device Manufacturer into NRXP Subsidiary HOPE Therapeutics
On April 3rd NRXP announced signing of a term sheet with a global medical device manufacturer, as anticipated in the Company's recently filed annual report. The investor shares NRXP subsidiary HOPE's vision of providing comprehensive interventional psychiatry treatments to patients around the world. This Investment is intended to support initiation of HOPE's network of clinics to treat suicidal depression and PTSD with ketamine, TMS and other modalities.
The Term Sheet, which is non-binding and subject to the execution of a definitive Stock Purchase Agreement, contemplates an investment of $2.5 million to purchase Series A Convertible Preferred Stock at a $50 million pre-money valuation. This investment, together with expected bank financing and current balance sheet assets, is anticipated to close concurrent with, and in support of, the closing of HOPE's recently announced clinic acquisitions.
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. ((Stock Symbol: NRXP)
Contact Person: Matthew Duffy, Chief Business Officer
Company Website: https://www.nrxpharma.com/
Email: mduffy@nrxpharma.com
Phone: (484) 254-6134
Home Country: United States
DISCLAIMER: https://corporateads.com/disclaimer/
Disclosure listed on the CorporateAds website
Source: Corporate Ads
0 Comments
Latest on Jersey Desk
- YOKE Expands NIL Club Into Athlete-Led Commerce With Athlete Merch Launch
- Floor Kings Announces Official Launch of Premier Epoxy Flooring Services Across Arizona
- UK Buyers Purchase Luxury Home in Keene's Pointe, Windermere (Orlando, Florida)
- Instant IP Launches Rapid Takedown Service to Combat IP Theft, Deepfakes, and Copycat Websites
- Su Che Publishing Announces New Children's Book Celebrating Vaisakhi Festival
- Permian Museum Adds Photos of Fossils Discovered on a Meteorite
- This Saturday: Open House for Manalapan's Newest Single Family Home Community
- VirtualFit Launches AI-Powered Virtual Try-On Platform for Fashion Brands, Influencers, and Shoppers
- Radarsign™ Awarded Sourcewell Contract Expanding Access to Traffic Safety Solutions
- Free Community Book Fair in Newark
- MainConcept and NETINT Bring VPU Acceleration to Easy Video API
- How Thick Can You Spot Weld? - Help Welders Improve Precision and Safety
- Larry R. Wasion's Jump Gate 2: Teleporter Expands the Time Travel Universe with High-Stakes Action and Ethical Dilemmas
- Bruce A. Rosenblat Releases A Pocket Full of Change, a Sharp, Thought-Provoking Book on Growth, Perspective, and Personal Change
- Marcus Boyd Announces Upcoming Children's Book The Royal World of Autism and Expands His Global Advocacy for Autism Awareness
- You Are Not Broken: "I Am Unique" Is Transforming Women's Lives Through Healing, S
- ASE Heating & Cooling Announces Enhanced 24/7 Emergency HVAC Repair Services in Hackettstown, NJ
- Phuket Bike Week Rebrands as Hard Rock Cafe Phuket Bike Week Under Landmark 5-Year Partnership
- From Survival to Stability: Inspiring Safe Haven Is Transforming Lives Across South Jersey
- L2 Aviation Appoints Tony Bailey as President and Chief Operating Officer