Latest news with #HOPETherapeutics
Associated Press
a day ago
- Business
- Associated Press
NRx Pharmaceuticals (NASDAQ: NRXP) Reports Q2 2025 Results, Highlights Progress Across Lead Programs
LOS ANGELES, CA - August 19, 2025 ( NEWMEDIAWIRE ) - NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, reported financial results for the quarter ended June 30, 2025, and provided a corporate update. The Company highlighted progress in all three lead programs, including expanded FDA Fast Track designation for NRX-100 in treating suicidal depression, filing of multiple regulatory documents, and advancement of the NRX-101 NDA. A strategic investor group led by B Group Capital has committed capital through a purchase of restricted common stock with a one-year lockup and no dilutive mechanisms. The capital is expected to support the Company through key regulatory milestones and help scale HOPE Therapeutics and its clinic network. 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 depression, chronic pain, and PTSD. The Company is developing NRX-100 (preservative-free intravenous ketamine) and NRX-101, (oral D-cycloserine/lurasidone). NRX-100 has been awarded Fast Track Designation for the treatment of Suicidal ideation in Depression, including Bipolar Depression. NRX-101 has been awarded Breakthrough Therapy Designation for the treatment of suicidal bipolar depression; the company recently filed module 3 manufacturing data to support the New Drug Application for NRX-101. NRx has recently filed an Abbreviated New Drug Application (ANDA) and initiated a New Drug Application filing for NRX-100 (IV ketamine) with an application for the Commissioner's National Priority Voucher Program for the treatment of suicidal depression. The filing is based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and the Government of France, licensed under a data sharing agreement. Please see full terms of use and disclaimers on the InvestorBrandNetwork website applicable to all content provided by IBN, wherever published or re-published: 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.
Globe and Mail
a day ago
- Business
- Globe and Mail
NRx Pharmaceuticals (NASDAQ: NRXP) Reports Q2 2025 Results, Highlights Progress Across Lead Programs
NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, reported financial results for the quarter ended June 30, 2025, and provided a corporate update. The Company highlighted progress in all three lead programs, including expanded FDA Fast Track designation for NRX-100 in treating suicidal depression, filing of multiple regulatory documents, and advancement of the NRX-101 NDA. A strategic investor group led by B Group Capital has committed capital through a purchase of restricted common stock with a one-year lockup and no dilutive mechanisms. The capital is expected to support the Company through key regulatory milestones and help scale HOPE Therapeutics and its clinic network. 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 depression, chronic pain, and PTSD. The Company is developing NRX-100 (preservative-free intravenous ketamine) and NRX-101, (oral D-cycloserine/lurasidone). NRX-100 has been awarded Fast Track Designation for the treatment of Suicidal ideation in Depression, including Bipolar Depression. NRX-101 has been awarded Breakthrough Therapy Designation for the treatment of suicidal bipolar depression; the company recently filed module 3 manufacturing data to support the New Drug Application for NRX-101. NRx has recently filed an Abbreviated New Drug Application (ANDA) and initiated a New Drug Application filing for NRX-100 (IV ketamine) with an application for the Commissioner's National Priority Voucher Program for the treatment of suicidal depression. The filing is based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and the Government of France, licensed under a data sharing agreement. 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: Corporate Communications
Globe and Mail
03-04-2025
- Business
- Globe and Mail
Large Strategic Investment from Global Medical Device Manufacturer to Support Clinics Treating Suicidal Depression and PTSD with Groundbreaking Drugs and Modalities: $NRXP
$NRXP Set Up for $300 Million in Milestones on Tiered Double-Digit Royalties Term Sheet Signed for $2.5 Million Strategic Investment from a Global Medical Device Manufacturer into NRXP Subsidiary HOPE Therapeutics. 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). New Drug Application for Treatment of Suicidal Depression; Planned NDA for Accelerated Approval for Bipolar Depression in People at Risk of Akathisia. Binding Letter of Intent with Neurospa TMS Holdings, LLC for Expansion of its Planned International Network of Interventional Psychiatry Clinics. 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. (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: 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. Binding Letter of Intent with Neurospa TMS Holdings, LLC for Expansion of its Planned International Network of Interventional Psychiatry Clinics On March 24th NRXP announced signing of a binding Letter of Intent to acquire a majority interest in Neurospa TMS Holdings, LLC. Neurospa operates six interventional psychiatry clinics on Florida's Gulf Coast and will constitute a key element of HOPE's Florida network going forward. Neurospa is revenue generating and EBITDA positive. Neurospa leverages state-of-the-art interventional psychiatry procedures, including Ketamine Infusion Therapy, Transcranial Magnetic Stimulation (TMS), and Spravato®, augmented by traditional psychiatry and talk therapy to provide a full continuum of care for people with depression, suicidality, PTSD, anxiety, and related disorders. TMS is an FDA-approved procedure in which focused electromagnetic treatment has been demonstrated to reduce symptoms of depression. Ketamine and Spravato® are similarly known to reduce symptoms of depression and both forms of treatment are increasingly used in an additive manner. Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update On March 17th NRXP announced its financial results for the quarter and year ended December 31, 2024, and provided a business update. The announcement included the following key highlights: NRXP initiated filing of a New Drug Application ("NDA") to the FDA for NRX-100 (IV Ketamine) for the treatment of Suicidal Depression; planned filing of an NDA for Accelerated Approval under Breakthrough Designation and Priority Review of NRX-101 for the treatment of bipolar depression in people at risk of akathisia. Both have anticipated PDUFA dates prior to December 31, 2025 NRXP has accepted non-binding potential terms from a commercial pharmaceutical company to license and distribute NRX-100, providing over $300 million in milestones plus tiered double-digit royalties based on net sales NRXP retained a leading regulatory law firm to file a citizen's petition with the US Food and Drug Administration ("FDA") to remove benzethonium chloride – a toxic preservative -- from presentations of ketamine intended for intravenous use; planned 2Q25 filing of an Abbreviated New Drug Application ("ANDA") for the use of preservative-free ketamine in all current indications Wholly owned subsidiary HOPE Therapeutics, signed non-binding letters of intent to acquire three precision psychiatry centers and is currently completing financial due diligence and definitive agreements. Currently negotiating the terms for the acquisition of six additional centers The HOPE acquisitions are planned to form the foundation for a national network offering interventional psychiatry services to treat suicidal depression, post-traumatic stress disorder ("PTSD") and related conditions NRXP received and negotiating a term sheet from a publicly-traded strategic investor currently engaged in manufacturing Transcranial Magnetic Stimulation ("TMS") devices to provide capital in support of expansion of further HOPE clinic acquisitions. NRXP has engaged BTIG as financial advisor for clinic acquisition and capital formation; leading global financial services firm specializing in investment banking, institutional trading, research, and related brokerage services for strategic growth opportunities. NRXP regained compliance with the NASDAQ market value of listed securities ("MVLS") requirement. Substantially reduced operating costs compared to prior year Management continues to forecast, although no assurances can be given, profitability on a forward-looking run-rate basis by year end 2025 NRXP filed Module 3 (manufacturing) of its New Drug Application ("NDA") for NRX-100 (preservative-free sterile IV ketamine) in a tamper-resistant, diversion resistant packaging presentation in the fourth quarter of 2024. NRX-100 was previously granted Fast Track Designation by FDA in combination with use of NRX-101. Ketamine efficacy data from four clinical trials are intended to support the filing. Three manufacturing lots are now complete, with filed stability data suitable for shelf life exceeding two years at room temperature. The anticipated PDUFA date for this NDA is prior to December 31, 2025. NRX-100 is poised to address the over $3 billion Suicidal Depression market in the US. NRXP has accepted non-binding potential terms from a commercial pharmaceutical company to license and distribute NRX-100 (preservative-free IV ketamine) that provides for over $300 million in potential milestones plus a tiered double-digit royalty, subject to further due diligence and finalized agreement. NRXP estimates that the market for the initial indication is over $2 billion, while the broad bipolar market could exceed $5 billion. 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:
Associated Press
12-03-2025
- Business
- Associated Press
NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) to Report Fourth Quarter and Full Year 2024 Financial Results and Provide a Corporate Update on March 17, 2025
- Conference call to take place at 8:30am ET - WILMINGTON, Del., March 12, 2025 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ('NRx Pharmaceuticals', the 'Company'), a clinical-stage biopharmaceutical company, today announced that it will release its fourth quarter and full year 2024 financial results before the market opens on Monday, March 17, 2025 via press release, which will be available on the Company's website at The Company will host a conference call to discuss the financial results as well as provide a corporate update at 8:30am ET the same day. A live webcast of the conference call will be available on the Company's website at Participants that are unable to join the webcast can access the conference call via telephone by dialing domestically +1-800-717-1738 or internationally +1-646-307-1865. About NRx Pharmaceuticals 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. About HOPE Therapeutics, Inc. HOPE Therapeutics, Inc. ( is a development stage healthcare delivery company that intends to develop 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. Notice Regarding Forward-Looking Statements The information contained herein includes forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as 'may,' 'will,' 'should,' 'would,' 'expect,' 'plan,' 'believe,' 'intend,' 'look forward,' and other similar expressions among others. These statements relate to future events or to the Company's future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects the Company's current views with respect to future events and is subject to these and other risks, including risks arising from uncertainties and assumptions relating to the Company's operations, results of operations, growth strategy, liquidity, HOPE Therapeutic's ability to consummate the acquisitions of providers for its national network, the Company's ability to raise adequate capital to fund such acquisitions, and the Company's ability to spin-off HOPE Therapeutics. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's most recent Annual Report on Form 10-K and other filings with the Securities and Exchange Commission. Investors and security holders are urged to read these documents free of charge on the SEC's website at Except as may be required by applicable law, The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, whether as a result of new information, future events or otherwise.
