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Globe and Mail
19 hours ago
- Business
- Globe and Mail
$750 Million Market Projected to Reach $3.35 Billion Globally in 2034 for Abbreviated New Drug Application Filed on Preservative-Free IV Ketamine: NRx Pharmaceuticals, Inc. (Nasdaq: NRXP)
$NRXP Has $7.8 Million in Financing for Clinic Acquisitions and Purchase of Kadima Neuropsychiatry Institute as Treatment Model and Leading Investigative Site for Suicidal Depression / PTSD 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). Abbreviated New Drug Application Filed for Preservative-Free IV Ketamine. Current Ketamine Market Estimated at $750 Million and Projected to Reach $3.35 Billion Globally in 2034. $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). Accepted Non-Binding Potential Terms to License and Distribute NRX-100 Drug Providing Over $300 Million in Milestones Plus Tiered Double-Digit Royalties. Application to Uplist to NASDAQ Global Market from NASDAQ Capital Market 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. 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: Abbreviated New Drug Application (ANDA) for Preservative-Free IV Ketamine On June 5th NRXP announced the transmission of its Abbreviated New Drug Application (ANDA) for electronic filing to the U.S. Food and Drug Administration (FDA) for NRX-100, its preservative-free IV ketamine formulation, for use in all existing approved indications such as anesthesia and pain management. NRXP anticipates filing a citizen's petition with the FDA to remove benzethonium chloride, a known neurotoxic and cytotoxic substance, from presentations of ketamine intended for intravenous use. NRXP believes that the preservative-free feature of NRX-100 will be deemed of benefit to patients because of the known toxicity of closely related benzalkonium chloride in current drug products. Preservatives were originally added to sterile injectable products in an era when a single vial of medication was used to treat multiple patients, a practice no longer allowed in US hospitals. NRXP has demonstrated that there is no need for such preservatives to maintain stability and sterility in ketamine presentations intended for single-patient use. Should the citizen's petition be granted, all formulations of ketamine sold in the US could face a regulatory requirement to be preservative free. $7.8 Million Debt Financing to Fuel NRXP HOPE Clinic Acquisitions 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. 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. "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). Disclosure listed on the CorporateAds website Media Contact Company Name: NRx Pharmaceuticals, Inc. Contact Person: Matthew Duffy, Chief Business Officer Email: Send Email Phone: 484 254 6134 Address: 1201 Orange Street Suite 600 City: Miami State: Florida Country: United States Website:
Yahoo
28-05-2025
- Business
- Yahoo
NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Acquires Kadima Institute to Launch $100M Psychiatry Clinic Network
NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) and its subsidiary, HOPE Therapeutics, Inc., are making a major move in mental health care with the acquisition of Kadima Neuropsychiatry Institute in La Jolla, California. Announced today, the definitive agreement marks a strategic expansion for NRXP, positioning Kadima as the clinical model for HOPE's planned network of interventional psychiatry clinics across the U.S. A biotechnologist in a lab coat discussing a therapeutic antibody with a colleague. Kadima, renowned for its integration of advanced clinical care and research, particularly in psychedelic medications and transcranial magnetic stimulation (TMS), will now anchor HOPE's ambitious nationwide rollout. The acquisition is expected to immediately boost both revenue and EBITDA, bringing profitability to the group. Dr. David Feifel, Kadima's founder and a recognized leader in interventional psychiatry, will join HOPE Therapeutics as Chief Medical Innovation Officer. NRx Pharmaceuticals, Inc. (NASDAQ:NRXP)'s broader pipeline includes investigational drugs for suicidal bipolar depression and chronic pain. HOPE Therapeutics aims to acquire 30 clinics by the end of 2025, with a projected $100 million in annual revenue. Kadima's comprehensive treatment offerings for suicidal depression, PTSD, and other mental health conditions set a new standard for the company's expanding footprint in psychiatric care. While we acknowledge the potential of NRXP to grow, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than NRXP and that has 100x upside potential, check out our report about this READ NEXT: and Disclosure: None. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
28-05-2025
- Business
- Yahoo
NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Acquires Kadima Institute to Launch $100M Psychiatry Clinic Network
NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) and its subsidiary, HOPE Therapeutics, Inc., are making a major move in mental health care with the acquisition of Kadima Neuropsychiatry Institute in La Jolla, California. Announced today, the definitive agreement marks a strategic expansion for NRXP, positioning Kadima as the clinical model for HOPE's planned network of interventional psychiatry clinics across the U.S. A biotechnologist in a lab coat discussing a therapeutic antibody with a colleague. Kadima, renowned for its integration of advanced clinical care and research, particularly in psychedelic medications and transcranial magnetic stimulation (TMS), will now anchor HOPE's ambitious nationwide rollout. The acquisition is expected to immediately boost both revenue and EBITDA, bringing profitability to the group. Dr. David Feifel, Kadima's founder and a recognized leader in interventional psychiatry, will join HOPE Therapeutics as Chief Medical Innovation Officer. NRx Pharmaceuticals, Inc. (NASDAQ:NRXP)'s broader pipeline includes investigational drugs for suicidal bipolar depression and chronic pain. HOPE Therapeutics aims to acquire 30 clinics by the end of 2025, with a projected $100 million in annual revenue. Kadima's comprehensive treatment offerings for suicidal depression, PTSD, and other mental health conditions set a new standard for the company's expanding footprint in psychiatric care. While we acknowledge the potential of NRXP to grow, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than NRXP and that has 100x upside potential, check out our report about this READ NEXT: and Disclosure: None.
Yahoo
13-05-2025
- Business
- Yahoo
IBN Coverage: NRx Pharmaceuticals (NASDAQ: NRXP) Subsidiary HOPE Therapeutics to Acquire Kadima Neuropsychiatry Institute
This article was published by IBN, a multifaceted communications organization engaged in connecting public companies to the investment community. LOS ANGELES, CA - May 13, 2025 (NEWMEDIAWIRE) - NRx Pharmaceuticals (NASDAQ: NRXP) announced that its wholly owned subsidiary, HOPE Therapeutics(TM), has signed a definitive agreement to acquire the Kadima Neuropsychiatry Institute. Kadima, a leading California clinic for interventional psychiatry, offers treatments such as ketamine, Spravato, transcranial magnetic stimulation (TMS), and medication management for CNS disorders including suicidal depression and PTSD. The clinic is profitable and expected to serve as the clinical model for future HOPE clinics. Dr. David Feifel, Kadima's founder and a nationally recognized leader in interventional psychiatry, will join HOPE as its first Chief Medical Innovation Officer following the closing of the acquisition, which remains subject to customary conditions and financing. To view the full press release, visit About NRx Pharmaceuticals, Inc. 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 to act as a non-opioid treatment for chronic pain, as well as a treatment for complicated UTI. NRx has recently initiated a New Drug Application filing for NRX-100 (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. For more information, please visit NOTE TO INVESTORS: IBN is a multifaceted financial news, content creation and publishing company utilized by both public and private companies to optimize investor awareness and recognition. For more information, please visit Please see full terms of use and disclaimers on the InvestorBrandNetwork website applicable to all content provided by IBN, wherever published or re-published: The latest news and updates relating to NRXP are available in the company's newsroom at Forward Looking Statements Certain statements in this article are forward-looking, as defined in the Private Securities Litigation Reform Act of 1995. These statements involve risks, uncertainties, and other factors that may cause actual results to differ materially from the information expressed or implied by these forward-looking statements and may not be indicative of future results. These forward-looking statements are subject to a number of risks and uncertainties, including, among others, various factors beyond management's control, including the risks set forth under the heading "Risk Factors" discussed under the caption "Item 1A. Risk Factors" in Part I of the Company's most recent Annual Report on Form 10-K or any updates discussed under the caption "Item 1A. Risk Factors" in Part II of the Company's Quarterly Reports on Form 10-Q and in the Company's other filings with the SEC. Undue reliance should not be placed on the forward-looking statements in this article in making an investment decision, which are based on information available to us on the date hereof. All parties undertake no duty to update this information unless required by law. About IBN IBN is a cutting-edge communications and digital engagement platform providing tailored Platform Solutions for select private and public companies. Over the course of 19+ years, IBN has introduced over 70 investor facing brands to the investment public and amassed a collective audience of millions of social media followers. These distinctive investor brands amplify recognition and reach as well as help fulfill the unique needs of our rapidly growing and diverse base of client-partners. IBN will continue to expand our branded network of influential properties as well as leverage the energy and experience of our team of professionals to best serve our clients. IBN's Platform Solutions provide access to: (1) our Dynamic Brand Portfolio (DBP) through 70+ investor facing brands; (2) article and editorial syndication to 5,000+ news outlets; (3) full-scale distribution to a growing Social Media Network (SMN) ; (4) a network of wire solutions via InvestorWire to effectively reach target markets and demographics; (5) Press Release Enhancement to ensure accuracy and impact; (6) a full array of corporate communications solutions; and (7) total news coverage solutions. For more information, please visit Please see full terms of use and disclaimers on the InvestorBrandNetwork website applicable to all content provided by IBN, wherever published or re-published: Media Contact IBNLos Angeles, OfficeEditor@ View the original release on Sign in to access your portfolio
Yahoo
13-05-2025
- Business
- Yahoo
HOPE Therapeutics, Inc. and NRx Pharmaceuticals (NASDAQ:NRXP) Announce Signing of Definitive Agreement to Purchase Kadima Neuropsychiatry Institute; Foundational Acquisition for the HOPE Network of Interventional Psychiatry Clinics
Kadima Neuropsychiatry Institute in La Jolla, CA expected to serve as clinical model for Hope 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, a nationally recognized pioneer in interventional psychiatry to join HOPE as Chief Medical Innovation Officer upon closing Acquisition expected to be accretive to revenue and EBITDA for NRx and HOPE MIAMI, May 13, 2025 /PRNewswire/ -- HOPE Therapeutics™, Inc. ("HOPE"), a medical and technology-driven company and wholly-owned subsidiary of NRx Pharmaceuticals, Inc. ("NRx" or the "Company") (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, today 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 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 HOPE as its first Chief Medical Innovation Officer ("CMIO") upon closing of the acquisition. A nationally recognized expert in interventional psychiatry, Dr. Feifel's distinctions include serving as an elected member of the American College of Neuropharmacology, peer-elected inclusion in "Best Doctors in America," and citation in the Castle Connolly list of "Top Doctors" — a recognition given to only 10 psychiatrists in San Diego. Dr. Feifel sits on the Board of the Clinical TMS Society and has co-chaired its clinical standards committee. Dr. Feifel has served as lead investigator on numerous clinical trials of therapies for CNS disorders. "The signing of a definitive agreement to acquire Kadima marks a pivotal moment in the execution of our strategy to redefine mental healthcare access and delivery of care through HOPE Therapeutics," said Dr. Jonathan Javitt and Matthew Duffy, Co-CEOs of HOPE . "Dr. David Feifel is a true pioneer in interventional psychiatry and we are honored to have him join our leadership team. With his guidance, we are accelerating the buildout of a world-class clinic network that integrates cutting-edge science with community-based care." The planned acquisition of Kadima is subject to satisfaction of standard closing conditions and finalization of financing. Further details on the transaction will be disclosed at that time. About NRx Pharmaceuticals, Inc. 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 to act as a non-opioid treatment for chronic pain, as well 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. About HOPE Therapeutics, Inc. HOPE Therapeutics, Inc. ( a subsidiary of NRx Pharmaceuticals, is a healthcare delivery company that is building a best-in-class network of interventional psychiatry clinics to offer ketamine, transcranial magnetics stimulation (TMS), and other lifesaving therapies to patients with suicidal depression and related disorders, together with a digital therapeutic-enabled platform designed to augment and preserve the clinical benefit of NMDA-targeted drug therapy. For further information: Matthew Duffy Brian KorbCo-CEO, Hope Therapeutics, Inc. Managing Partner, ASTR PartnersChief Business Officer, NRx Pharmaceuticals, Inc. (917) 653-5122mduffy@ original content to download multimedia: SOURCE NRx Pharmaceuticals, Inc. 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