Trending...
- Pyro Marketing Opens New Digital Marketing Company to Power Growth for Fitness and Ecommerce Brands
- Beijing Review: ChASC5 Bridging Hearts Across The Pacific
- BMCC Tribeca PAC Presents New Season of Music, Theater & Family Fun
$NRXP NRx Pharmaceuticals, Inc. (Stock Symbol: NRXP): Set Up for $300 Million in Milestones on Tiered Double-Digit Royalties
MIAMI - Nyenta -- 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).
$7.8 Million Debt Financing to Fuel NRXP HOPE Clinic Acquisitions with
Universal Capital, LLC.
Added to Previously Announced Term Sheet with a Strategic Investor, NRXP HOPE Funding of $10.3 Million is Planned in Near Term.
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.
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 NASDAQ Global Market from NASDAQ Capital 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 Nyenta.com
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.
$7.8 Million Debt Financing to Fuel NRXP HOPE Clinic Acquisitions
Term sheet with Universal Capital, LLC to fund HOPE Therapeutics clinic acquisition strategy
Funding tied to already-announced acquisitions, with additional tranches contemplated for further growth, subject to standard due diligence
Together with previously announced term sheet with a strategic investor, HOPE funding of $10.3 million is planned in the near term
On May 15th NRXP announced signing of a term sheet with Universal Capital, LLC to provide $7.8 million in acquisition capital to initiate subsidiary HOPE's planned national rollup of interventional psychiatry clinics, commencing with previously-announced acquisitions of Dura Medical, Kadima, and NeuroSpa. Together with proceeds of a previously announced strategic investment, this financing is anticipated to provide $10.3 million in acquisition capital.
HOPE's three initial acquisitions represent best-in-class clinics that offer neuroplastic treatments including NRXP ketamine and transcranial magnetic stimulation (TMS) to treat patients with severe depression, PTSD, and related central nervous system conditions. Neuroplastic treatments represent a rapidly emerging class of interventions that cause the growth of new connections (synapses) between brain cells that have been shown in multiple clinical trials to relieve symptoms of depression and suicidality. The FDA has approved TMS devices for a number of indications and has approved a nasal form of ketamine for treatment resistant depression. HOPE's parent company, NRXP, is currently applying to the FDA for approval of intravenous preservative-free ketamine to treat suicidal depression.
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.
More on Nyenta.com
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.
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).
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).
$7.8 Million Debt Financing to Fuel NRXP HOPE Clinic Acquisitions with
Universal Capital, LLC.
Added to Previously Announced Term Sheet with a Strategic Investor, NRXP HOPE Funding of $10.3 Million is Planned in Near Term.
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.
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 NASDAQ Global Market from NASDAQ Capital 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 Nyenta.com
- $HAREHOLDER ALERT: The M&A Class Action Firm Launches Legal Inquiry for the Merger: FL, STRM, TXNM, and CTLP
- Pyro Marketing Launches New Website to Accelerate Growth for Fitness Brands
- Happi Coffee Launches with a Mission to Bring Freshness, Simplicity, and Intention to Your Daily Cup
- SHAREHOLDER REMINDER: Faruqi & Faruqi, LLP Investigates Claims on Behalf of Investors of Krispy Kreme
- Local firm Launches QuickBooks Support to Help Small Businesses Streamline Finances and Boost Growth
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.
$7.8 Million Debt Financing to Fuel NRXP HOPE Clinic Acquisitions
Term sheet with Universal Capital, LLC to fund HOPE Therapeutics clinic acquisition strategy
Funding tied to already-announced acquisitions, with additional tranches contemplated for further growth, subject to standard due diligence
Together with previously announced term sheet with a strategic investor, HOPE funding of $10.3 million is planned in the near term
On May 15th NRXP announced signing of a term sheet with Universal Capital, LLC to provide $7.8 million in acquisition capital to initiate subsidiary HOPE's planned national rollup of interventional psychiatry clinics, commencing with previously-announced acquisitions of Dura Medical, Kadima, and NeuroSpa. Together with proceeds of a previously announced strategic investment, this financing is anticipated to provide $10.3 million in acquisition capital.
HOPE's three initial acquisitions represent best-in-class clinics that offer neuroplastic treatments including NRXP ketamine and transcranial magnetic stimulation (TMS) to treat patients with severe depression, PTSD, and related central nervous system conditions. Neuroplastic treatments represent a rapidly emerging class of interventions that cause the growth of new connections (synapses) between brain cells that have been shown in multiple clinical trials to relieve symptoms of depression and suicidality. The FDA has approved TMS devices for a number of indications and has approved a nasal form of ketamine for treatment resistant depression. HOPE's parent company, NRXP, is currently applying to the FDA for approval of intravenous preservative-free ketamine to treat suicidal depression.
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.
More on Nyenta.com
- KCON LA 2025, 106.3 RAIN FM 'Take Over' Special Event
- Natcast Celebrates Grand Opening of NSTC EUV Accelerator at NY CREATES' Albany NanoTech Complex, One of Three NSTC Flagship Semiconductor R&D Facilities Across the Country
- Don't Let a Lawsuit Take Away Everything: Attorney Blake Harris Joins Tom Hegna on "Financial Freedom with Tom Hegna"
- New Book Executive One Chronicles the Visionary Leadership of Ernest E. Middleton, PhD
- What do a Police Officer, a Retiree, and an 8-Year-Old Girl have in Common?
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.
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).
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 Nyenta.com
- The Blue Luna Encourages Local Schools to Take Steps to Enhance Safety for Students and Staff
- Momentum Commerce Tracking of Amazon US Prime Day Sales Shows +165% Increase on Day 3, Path to Year-over-Year Growth
- The Sessions Studios Secures $300 Million Commitment to Launch World-Class Studio and 15-Film Global Slate
- Smart Resnse Unveils Smart Resnse(SRMS) Token-Powered AI Orchestration Platform to Revolutionize Multi-Billion Dollar Market
- Olson's Walk-Off Hit Gives N.L. All-Star Game Triumph In Strat-O-Matic Simulation
- Beijing Review: ChASC5 Bridging Hearts Across The Pacific
- Josh and Heidi Follow Up the Much Anticipated and Successful Launch of the "Spreading the Good BUZZ" Podcast with a Personal Request
- Revolutionary Blockchain Platform Okh Finance Announces Okh Finance(OKKH) Token Launch to Transform Global Asset Leasing Market
- Cover Girl Finalist Teisha Mechetti Questions Legitimacy of Inked Originals Competition, Demands Transparency
- Easton & Easton, LLP Files Suit Against The Dwelling Place Anaheim & Vineyard USA Over Abuse Allegations
- AI Visibility: The Key to Beating Google's AI Overviews and Regaining Traffic
- Rod Joseph Honored at First International Day of Hope in New York City
- Stuck Doing Math or Figuring Out Life's Numbers? Calculator.now Makes It Stupidly Simple
- Tronox Announces Dates for Second Quarter 2025 Earnings Release & Webcast Conference Call
- Colbert Packaging Announces WBENC Recognition
- Non-Profit Pay Away Announces Support to Boys & Girls Clubs of America for Back-to-School Giving
- RBLP Leadership Certifications is authorizing new Training Partners in New York
- BMCC Tribeca PAC Presents New Season of Music, Theater & Family Fun
- CPAmerica welcomes Trullion as a new Preferred Provider, supporting modernized accounting processes
- The Fabulous Wines of Provence, France