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$NRXP News: NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) and HOPE Therapeutics, Inc. Announce Strategic Investor Relations Partnership with astr partners
PR Newswire
Mon, June 16, 2025 at 8:03 AM EDT
In This Article:
NRXP ,NRXPW
WILMINGTON, Del., June 16, 2025 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", "NRx" or the "Company"), a clinical-stage biopharmaceutical company, and HOPE Therapeutics, Inc., ("HOPE," or the "Company"), a multi-site clinical care delivery organization and wholly-owned subsidiary of NRx, today announced a strategic investor relations partnership with astr partners, a boutique investor relations and capital advisory firm focused on the life sciences sector.
"We are pleased to partner with astr partners at this important inflection point for NRx, as we have filed an ANDA, are on the precipice of completing two NDA filings and are actively acquiring profitable interventional psychiatry clinics," said Jonathan Javitt, Chairman and CEO of NRx Pharmaceuticals. "Their depth of experience in biotech investor relations, broad relationships with specialist investors and the right investment banks, as well as their commitment to precision messaging, make astr the ideal team to help amplify the ongoing value story NRx and HOPE."
ASTR partners was founded by the industry veterans from The Trout Group, including Jonathan Fassberg and Brian Korb, who bring decades of combined experience in investor relations and healthcare capital markets. The Trout Group was the global leader in biotech investor relations, which was sold to PNC Bank. Jonathan and Brian later held senior roles at Solebury Trout and Oppenheimer & Co. The astr team works closely with biotech companies across a range of development stages — from early clinical to commercial — with a strong focus on strategic positioning and institutional engagement.
"We're thrilled to support NRx and HOPE as they advance meaningful neuropsychiatry therapies toward patients with critical unmet needs," said Jonathan Fassberg and Brian Korb, Managing Partners of astr. "Our team is excited to collaborate closely with NRx and HOPE to elevate their visibility and strengthen their relationships across the investment community at this key inflection point."
ASTR partners will work with the NRx and HOPE executive teams to execute a comprehensive investor relations program that includes investor targeting, message development, earnings preparation, conference support, and proactive investor engagement.
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. 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 recently filed an Abbreviated New Drug Application (ANDA) for NRX-100 (preservative free IV ketamine) for use in ketamine's currently approved indications. Additionally, the Company has initiated a New Drug Application filing for NRX-100 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. (www.hopetherapeutics.com), 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.
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. These statements include, among others, statements regarding the satisfaction of closing conditions necessary to consummate the acquisition of Kadima, Neurospa and Dura, and obtaining financing necessary to consummate the acquisitions. 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, uncertainties and assumptions relating to the Company's operations, results of operations, growth strategy, liquidity, whether the USPTO approves the Company's patent, and whether the FDA will approve the Company's NDA. 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 http://www.sec.gov. 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.
For further information:
Matthew Duffy
Brian Korb
Co-CEO, Hope Therapeutics, Inc.
Managing Partner, astr partners
Chief Business Officer, NRx Pharmaceuticals, Inc.
(917) 653-5122
mduffy@nrxpharma.com
brian.korb@astrpartners.com
$NRXP News: NRx Pharmaceuticals, Inc. (NASDAQ: $NRXP) and HOPE Therapeutics, Inc. to Present at H.C. Wainwright 6th Annual Neuro Perspectives Hybrid Conference
Link: https://ir.nrxpharma.com/2025-06-12-NRx-Pharmaceuticals,-Inc-NASDAQ-NRXP-and-HOPE-Therapeutics,-Inc-to-Present-at-H-C-Wainwright-6th-Annual-Neuro-Perspectives-Hybrid-Conference
WILMINGTON, Del., June 12, 2025 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", "NRx" or the "Company"), a clinical-stage biopharmaceutical company, and HOPE Therapeutics, Inc., ("HOPE," or the "Company"), a multi-site clinical care delivery organization and wholly-owned subsidiary of NRx, today announced participation in the H.C. Wainwright 6th Annual Neuro Perspectives Hybrid Conference, scheduled for June 16–17, 2025.
Dr. Jonathan Javitt, Founder, Chairman and Chief Executive Officer of NRx Pharmaceuticals and Co-CEO of HOPE, will deliver a corporate presentation highlighting the company's latest advances. The presentation will be available on demand to registered attendees beginning at 7:00 a.m. Eastern Time on Monday, June 16, 2025. In addition, the company will be participating in one-on-one meetings with investors throughout the conference. Please request 1:1 meetings on the HCW conference website listed below.
Event Details:
Date: Presentation available on-demand Monday, June 16, beginning at 7:00 a.m. ET for registered conference attendees
Registration: H.C. Wainwright 6th Annual Neuro Perspectives Registration
NRx Website: NRx Events
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 as a treatment for complicated UTI.
NRx recently filed an Abbreviated New Drug Application (ANDA) for NRX-100 (preservative free IV ketamine) for use in ketamine's currently approved indications. Additionally, the Company has initiated a New Drug Application filing for NRX-100 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. (www.hopetherapeutics.com), 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.
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. These statements include, among others, statements regarding the satisfaction of closing conditions necessary to consummate the acquisition of Kadima, Neurospa and Dura, and obtaining financing necessary to consummate the acquisitions. 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, uncertainties and assumptions relating to the Company's operations, results of operations, growth strategy, liquidity, whether the USPTO approves the Company's patent, and whether the FDA will approve the Company's NDA. 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 http://www.sec.gov. 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.
For further information:
Matthew Duffy
Brian Korb
Co-CEO, Hope Therapeutics, Inc.
Managing Partner, astr partners
Chief Business Officer, NRx Pharmaceuticals, Inc.
(917) 653-5122
mduffy@nrxpharma.com
brian.korb@astrpartners.com
SOURCE NRx Pharmaceuticals, Inc.
#PharmaNews #mentalhealth #depression #ketamine #PTSD #bipolar #NRXPharma #HopeTherapeutics
NRx Pharmaceuticals, Inc. (NASDAQ: $NRXP) and HOPE Therapeutics, Inc. to Present at H.C. Wainwright 6th Annual Neuro Perspectives Hybrid Conference
— NRx Pharmaceuticals (@NRxPharma) June 12, 2025
Read More - https://t.co/BFstPGwVIW#PharmaNews #mentalhealth #depression #ketamine #PTSD #bipolar #NRXPharma #HopeTherapeutics
$NRXP News: NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Files Abbreviated New Drug Application (ANDA) for Preservative-Free IV Ketamine
Ketamine faces a current US drug shortage not expected to abate in the near future1
Current ketamine market estimated at $750 million and projected to reach $3.35 billion globally in 2034.2 NRx anticipates marketing ketamine for all approved uses
Company anticipates priority review based on current and anticipated drug shortage
NRX-100 to provide innovative, preservative-free IV ketamine formulation to eliminate benzethonium chloride preservative, in keeping with current HHS priorities to eliminate toxic preservatives from foods and drugs
The Company anticipates filing a citizen's petition with the FDA to remove benzethonium chloride, a known neurotoxic and cytotoxic substance, from all presentations of ketamine intended for intravenous use
This filing complements the ongoing NDA submission for NRX-100 in suicidal depression; PDUFA anticipated in late 2025
WILMINGTON, Del., June 5, 2025 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP), a clinical-stage biopharmaceutical company, today 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.
The current annual ketamine market is estimated at $750 million, with global demand for ketamine projected to grow to $3.35 billion by 2034. This does not include the widespread use of compounded ketamine by clinics unable to obtain manufactured drug. NRx aims to capture a significant share of that existing market. According to a 2021 survey, an estimated 5.1 million Americans had received ketamine for medical uses in their lifetime3, a number that continues to grow with increased clinical focus on this important medication. Ketamine currently faces a severe drug shortage according to the American Society of Hospital Pharmacist with no short-term abatement. Accordingly, NRx is seeking priority review from FDA.
The Company 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. Management 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. NRx 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.
Today's filing supplements the New Drug Application currently being completed by the Company to extend the labeled indications of ketamine to include the treatment of suicidal depression. The Company anticipates submitting clinical trials data from more than 1,000 patients and real-world data from more than 180,000 patients in which ketamine demonstrated superiority to placebo and active placebo, with noninferiority to electroconvulsive therapy.
"This submission comes at a time when the demand for ketamine in the US market is rapidly increasing and the available supply is inadequate. We at NRx believe that safer, preservative-free formulations of ketamine will be increasingly preferred by physicians, patients, and regulators in this large and growing market." said Jonathan Javitt, MD, MPH, Chairman and CEO of NRx Pharmaceuticals. "NRX-100 is designed to replace older formulations that rely on potentially neurotoxic and cytotoxic preservatives for stability and sterility. We have filed a US patent on our novel, preservative-free formulation, which anticipates three years of room-temperature shelf stability."
In April 2025, the FDA granted a waiver of the $4.3 million NDA fee under the PDUFA, recognizing both the product's public health value and NRx's qualification under small business provisions. NRX-100 was previously granted Fast Track Designation in a protocol with NRX-101. With regulatory filings underway, patent protection sought through 2045, and a growing body of clinical and technical validation, NRx believes NRX-100 is well-positioned to become a next-generation standard in both the emerging mental health market and the current $750 million ketamine market, offering physicians and patients a safer, more reliable alternative to legacy ketamine products.
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 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. (www.hopetherapeutics.com), 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.
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. These statements include, among others, statements regarding the satisfaction of closing conditions necessary to consummate the acquisition of Kadima, Neurospa and Dura, and obtaining financing necessary to consummate the acquisitions. 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, uncertainties and assumptions relating to the Company's operations, results of operations, growth strategy, liquidity, whether the USPTO approves the Company's patent, and whether the FDA will approve the Company's NDA. 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 http://www.sec.gov. 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.
For further information:
Matthew DuffyCo-CEO, Hope Therapeutics,Chief Business Officer, NRx Pharmaceuticals, Inc.mduffy@nrxpharma.com
Brian KorbManaging Partner, astr partners(917) 653-5122brian.korb@astrpartners.com
1 https://www.ashp.org/drug-shortages/current-shortages/drug-shortage-detail.aspx?id=391
2 https://www.factmr.com/report/injectable-ketamine-market
3 https://www.radars.org/system/publications/NMURx%20Ketamine%20Use%20Poster_fin2.pdf
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SOURCE NRx Pharmaceuticals, Inc.
$NRXP NEWS: NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) and HOPE Therapeutics™, Inc. Selected to Present at the Wall Street Conference on May 21, 2025, in Palm Beach, Florida
PR Newswire: Wed, May 21, 2025 at 8:03 AM EDT
In This Article: NRXP, NRXPW
PALM BEACH, Fla., May 21, 2025 /PRNewswire/ -- NRx Pharmaceuticals, Inc. ("NRx" or the "Company") (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, today announced that that Jonathan Javitt, MD, MPH, Founder, Chairman and Chief Executive Officer of NRx Pharmaceuticals and Co-CEO of HOPE Therapeutics, will be presenting a Company update at the upcoming Wall Street Conference, taking place on May 21, 2025 in Palm Beach, FL. NRx is one of six companies invited to present.
The Wall Street Conference is expected to host over 1,000 attendees who are reported to represent over $1T in investment capital. Wall Street Conference Home
NRx will be discussing recent progress towards FDA approval of NRX-100 (preservative-free ketamine) and upcoming acquisitions of HOPE clinics providing state-of-the-art care for suicidal depression, PTSD, and related disorders.
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 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. (www.hopetherapeutics.com), 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.
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. These statements include, among others, statements regarding the satisfaction of closing conditions necessary to consummate the acquisition of Kadima, Neurospa and Dura, and obtaining financing necessary to consummate the acquisitions. 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, without limitation, 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, NRX-100 not being approved by the United States Food and Drug Administration, 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 http://www.sec.gov. 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.
For further information:
Matthew Duffy
Brian Korb
Co-CEO, Hope Therapeutics, Inc.
Managing Partner, ASTR Partners
Chief Business Officer, NRx Pharmaceuticals, Inc.
(917) 653-5122
mduffy@nrxpharma.com
brian.korb@astrpartners.com
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SOURCE NRx Pharmaceuticals, Inc.
$NRXP News: 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. (www.hopetherapeutics.com), 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 Korb
Co-CEO, Hope Therapeutics, Inc.
Managing Partner, ASTR Partners
Chief Business Officer, NRx Pharmaceuticals, Inc.
(917) 653-5122
mduffy@nrxpharma.com
brian.korb@astrpartners.com
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SOURCE NRx Pharmaceuticals, Inc.
$NRXP News: NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) to Report First Quarter 2025 Financial Results on May 15, 2025
PR Newswire
Mon, May 12, 2025 at 8:03 AM EDT
In This Article:
NRXP, NRXPW
WILMINGTON, Del., May 12, 2025 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced that it will release its first quarter 2025 financial results after the market closes on Thursday, May 15, 2025 via press release, which will be available on the Company's website at https://ir.nrxpharma.com/. The Company will host a conference call to discuss the financial results as well as provide a corporate update at 4:30pm ET the same day.
(PRNewsfoto/NRx Pharmaceuticals)
(PRNewsfoto/NRx Pharmaceuticals)
A live webcast of the conference call will be available on the Company's website at https://ir.nrxpharma.com/events. 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, 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.
About HOPE Therapeutics, Inc.
HOPE Therapeutics, Inc. (www.hopetherapeutics.com), 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.
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. These statements include, among others, statements regarding the satisfaction of closing conditions necessary to consummate the acquisition of Kadima, Neurospa and Dura, and obtaining financing necessary to consummate the acquisitions. 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, 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 http://www.sec.gov. 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.
For further information:
Matthew Duffy
Co-CEO, Hope Therapeutics, Inc.
Chief Business Officer, NRx Pharmaceuticals, Inc.
mduffy@nrxpharma.com
Brian Korb
Managing Partner, astr Partners
(917) 653-5122
brian.korb@astrpartners.com
HOPE Therapeutics, Inc. (PRNewsfoto/NRx Pharmaceuticals, Inc.)
HOPE Therapeutics, Inc. (PRNewsfoto/NRx Pharmaceuticals, Inc.)
Cision
Cision
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SOURCE NRx Pharmaceuticals, Inc.
$NRXP $2.02 +2.54% HOD $2.0599 #Bullish Move early!
$NRXP New Article via IBN Coverage- NRxPharma Files Patent for Preservative-Free Ketamine Formulation
IBN Coverage: This article was published by IBN, a multifaceted communications organization engaged in connecting public companies to the investment community.
LOS ANGELES, CA - May 6, 2025 (NEWMEDIAWIRE) - NRx Pharmaceuticals (NASDAQ: NRXP) a clinical-stage biopharma company, has filed a patent application for NRX-100, its preservative-free intravenous ketamine formulation targeting suicidal depression. The patent, which includes 20 claims, could provide exclusivity through 2045 if granted. NRX-100 is designed without benzethonium chloride or other preservatives linked to toxicity and has shown room temperature shelf stability - potentially qualifying it for FDA Orange Book listing. The filing supports the company's NDA submission strategy and complements the FDA Fast Track Designation of companion drug NRX-101.
To view the full press release, visit https://ibn.fm/X8uSQ
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 https://www.nrxpharma.com/
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.
https://finance.yahoo.com/news/ibn-coverage-nrx-pharmaceuticals-nasdaq-133000381.html
#PharmaNews #mentalillness #mentalhealth #depression #ketamine #PTSD #bipolar #psychiatry #healthcare #clinic #NRXPharma #HopeTherapeutics
Going to be interesting this week. $NRXP #bullish #WPB
Thin to 2.00's!
It sure would be nice if they would record this event and make it available to those of us with not so deep pockets that have the ability to drop everything on such short notice (two days, really?) and fly to Florida. I'm thinking this was a pre planned event that invitations were sent to High Stakes Investors and potential investors and sending out an invitation to us small investors was an after thought.
$NRXP News: HOPE Therapeutics, Inc. and NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) to Host Investor Event at Mar-A-Lago Club on May 8, 2025
PR Newswire
Tue, May 6, 2025 at 8:03 AM EDT
In This Article:
NRXP, NRXPW
MIAMI, May 6, 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 that it will host an investor event at the Mar-A-Lago Club in Palm Beach, Florida, on Thursday, May 8, 2025, at the invitation of club members.
This discussion is being held to review previously-disclosed strategic initiatives across HOPE and NRx Pharmaceuticals, including expansion plans for the HOPE network of interventional psychiatry clinics and progress across the NRx clinical pipeline. Current investors who wish to attend are invited to contact the Company.
Key Topics to be Discussed, based on previously disclosed information:
*Recently announced HOPE clinic acquisitions and potential to scale HOPE's interventional psychiatry network
*Plans for integration of digital health solutions, including CRM-based technology and telepsychiatry capabilities, to unify clinical operations across the HOPE network
*Status of the New Drug Application (NDA) for NRX-100 (preservative-free IV Ketamine), following FDA's grant of a $4.3 million filing fee waiver, for treating suicidal depression
*Recent filing of a patent for preservative-free ketamine (NRX-100). If granted, the patent could provide market exclusivity for NRX-100 into 2045
*Breakthrough Therapy Designation of NRX-101; currently preparing to file an NDA for Accelerated Approval in patients with bipolar depression and suicidality or akathisia
Dr. Jonathan Javitt, MD, MPH, Founder, Chairman and CEO of NRx Pharmaceuticals and Co-CEO of HOPE Therapeutics will lead the discussion.
"We are excited to continue to meet with our investor community to discuss the significant progress we've made recently," said Dr. Javitt. "Our continued focus on expanding access to innovative treatments and delivering on key regulatory and operational milestones underscores the potential of HOPE and NRx's leadership in mental health innovation."
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.
About HOPE Therapeutics, Inc.
HOPE Therapeutics, Inc. (www.hopetherapeutics.com), 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 magnetic 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. These statements include, among others, statements regarding the satisfaction of closing conditions necessary to consummate the acquisition of Kadima, Neurospa and Dura, and obtaining financing necessary to consummate the acquisitions. 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, 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 http://www.sec.gov. 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.
$NRXP premarket news! HOPE Therapeutics, Inc. and NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) to Host Investor Event at Mar-A-Lago Club on May 8, 2025 https://finance.yahoo.com/news/hope-therapeutics-inc-nrx-pharmaceuticals-120300821.html?soc_src=social-sh&soc_trk=tw&tsrc=twtr
Excellent progress reported in the NRXP news today. They are wasting no time in moving to get their life-saving NRX-10 treatment to approval for the many who need it.
From the announcement:
"We are committed to delivering safer, more effective treatments for patients with suicidal depression," said Jonathan Javitt MD MPH, CEO of NRx Pharmaceuticals. "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."
$NRXP News: NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Files Patent Application for NRX-100, its Proprietary, Preservative Free Formulation of IV Ketamine
PR Newswire
Mon, May 5, 2025 at 8:03 AM EDT
In This Article:
NRXP ,NRXPW
Patent expected to be Orange Book listable, if granted
NRX-100, preservative free, IV ketamine, is designed to avoid potential toxicity concerns linked to benzethonium chloride, used in currently available formulations of ketamine
Filing strengthens NRx's leadership in advancing safe and effective treatments for suicidal depression
WILMINGTON, Del., May 5, 2025 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today 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.
NRX-100 is specifically formulated without benzethonium chloride or other preservatives, which have been associated with cytotoxic or neurotoxic effects. Current governmental leadership has expressed strong interest in delivering medications without unnecessary or unproven preservatives. Demonstration of room temperature shelf stability in the absence of toxic excipients represents a novel pharmaceutical composition that has the potential to be listed in the FDA Orange Book. This patent filing builds on the Company's 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 NRx 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 NRx Pharmaceuticals. "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."
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.
About HOPE Therapeutics, Inc.
HOPE Therapeutics, Inc. (www.hopetherapeutics.com), 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 Korb
Co-CEO, Hope Therapeutics, Inc.
Managing Partner, ASTR Partners
Chief Business Officer, NRx Pharmaceuticals, Inc.
(917) 653-5122
mduffy@nrxpharma.com
brian.korb@astrpartners.com
Good morning $NRXP Huge news!
$NRXP May is Mental Health Awareness Month. NRx Pharmaceuticals is focused on the high unmet need for lifesaving treatments for people with severe bipolar depression and PTSD in the presence of suicidality.
Follow our journey. https://NRxPharma.com
#PharmaNews #mentalillness
May is Mental Health Awareness Month. NRx Pharmaceuticals is focused on the high unmet need for lifesaving treatments for people with severe bipolar depression and PTSD in the presence of suicidality.
— NRx Pharmaceuticals (@NRxPharma) May 2, 2025
Follow our journey. https://t.co/ADAM0yK8Vu#PharmaNews #mentalillness
Very positive development reported in the NRXP news today with the FDA granting the $4.3 million waiver exempting NRx from paying a New Drug Application filing fee under the Prescription Drug User Fee Act (PDUFA).
From the announcement:
"We at NRx are encouraged by this important fee waiver from the FDA and by the posture expressed by the new leadership of the Department of Health and Human Services in support of new psychedelic drugs to treat the more than 3 million Americans who consider suicide every year and currently have no approved treatment other than electroshock therapy," said Dr. Jonathan Javitt, CEO and Chairman of NRx Pharmaceuticals. "NRx aims to make its preservative-free ketamine available to physicians who care for patients with suicidal depression and PTSD."
$NRXP News: NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Announces FDA Award of Filing Fee Waiver for Upcoming NRX-100 (preservative free ketamine) New Drug Application to Treat Patients with Suicidal Depression
PR Newswire
Wed, April 30, 2025 at 8:46 AM EDT 6 min read
In This Article:
NRXP, NRXPW
Waiver exempts NRx from paying a $4.3 million New Drug Application filing fee under the Prescription Drug User Fee Act (PDUFA)
Company is on track for Q2 2025 completion of NDA filing and PDUFA date by year end with currently available corporate resources
NRX-100, together with NRX-101, was granted Fast Track designation by FDA for treatment of suicidal bipolar depression in 2018
Company notes recent statements by Secretary of Health and Human Services regarding the public health importance of approving psychedelic drugs such as ketamine to treat suicidal depression and PTSD
MIAMI, April 30, 2025 /PRNewswire/ -- NRx Pharmaceuticals, Inc., (Nasdaq:NRXP or "the Company"), today 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. The Company 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).
(PRNewsfoto/NRx Pharmaceuticals)
(PRNewsfoto/NRx Pharmaceuticals)
NRX-100 is a preservative-free preparation of ketamine in a single-patient presentation. Currently-available forms of ketamine contain preservative – benzethonium chloride – the safety of which has never been demonstrated for repeated use. The preservative was added in the 1970s when ketamine was originally formulated as an anesthetic and the practice at the time was to package anesthetic drugs in multi-use vials that required a preservative to maintain sterility. Although benzethonium chloride has not demonstrated toxicity in anesthesia, this class of preservatives has been shown to be neurotoxic and cytotoxic to the tissues of the eye when incorporated in eye drops. NRx has now demonstrated stability and sterility sufficient to maintain more than two years of shelf life in a preservative-free presentation. This patent-pending process is anticipated to yield long-term exclusivity should NRX-100 be approved by the FDA.
As previously announced, NRx will be submitting data from controlled clinical trials that demonstrate ketamine to be superior to both a placebo and an active comparator, as well as either non-inferior or superior to electroshock therapy in treating various forms of depression, including patients with active suicidal ideation. Although ketamine in various forms is increasingly used to treat depression and related disorders, it is approved by FDA only for use as an anesthetic and, therefore, not reimbursed by most insurance carriers for treatment of suicidality or depression. By applying for FDA approval to treat suicidal depression with NRX-100, the Company hopes to make this potentially life-saving therapy available to all Americans, not just those who are able to pay out of pocket.
The Company 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).
"We at NRx are encouraged by this important fee waiver from the FDA and by the posture expressed by the new leadership of the Department of Health and Human Services in support of new psychedelic drugs to treat the more than 3 million Americans who consider suicide every year and currently have no approved treatment other than electroshock therapy," said Dr. Jonathan Javitt, CEO and Chairman of NRx Pharmaceuticals. "NRx aims to make its preservative-free ketamine available to physicians who care for patients with suicidal depression and PTSD."
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.
About HOPE Therapeutics, Inc.
HOPE Therapeutics, Inc. (www.hopetherapeutics.com), 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.
Notice Regarding Forward-Looking Statement
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 uncertainties and assumptions relating to the Company's operations, results of operations, growth strategy, and, among other things, liquidity. 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 http://www.sec.gov. 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.
For further information:
Matthew Duffy
Chief Business Officer, NRx Pharmaceuticals
mduffy@nrxpharma.com
Brian Korb
Managing Partner
(917) 653-5122
brian.korb@astrpartners.com
Cision
Cision
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SOURCE NRx Pharmaceuticals, Inc.
$NRXP News: NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) and HOPE Therapeutics™, Inc.to Participate in an H.C. Wainwright @ Home Fireside Discussion on Tuesday, April 22, 2025
WILMINGTON, Del., April 21, 2025 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", or the "Company"), a clinical-stage biopharmaceutical company, and HOPE Therapeutics, Inc., ("HOPE," or the "Company"), an interventional psychiatry network wholly owned by NRx Pharmaceuticals, today announced that it will participate in an H.C. Wainwright @ Home fireside discussion, taking place on Tuesday, April 22, 2025 at 10AM EDT.
Jonathan Javitt, MD, MPH, Founder, Chairman and Chief Executive Officer of NRx Pharmaceuticals, and Co-CEO of HOPE Therapeutics, will participate in a fireside chat lead by HCW Senior Biotech Analyst, Vernon Bernardino.
Event Details:
Event: HCW @ Home with NRx Pharmaceuticals, Inc. (NRXP)
Date: Tuesday, April 22nd, 2025, 10:00 AM EDT
Webcast: https://ir.nrxpharma.com/events
Investors interested in watching the event can use the link above or contact their HC Wainwright representative to register.
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 recently announced initiation of filing a New Drug Application 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. (www.hopetherapeutics.com) 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. These statements include, among others, statements regarding the satisfaction of closing conditions necessary to consummate the acquisition of Kadima and Dura, and obtaining financing necessary to consummate the acquisitions. 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, 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 http://www.sec.gov. 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.
For further information:
Matthew Duffy
Chief Business Officer, NRx Pharmaceuticals
Co-Chief Executive Officer, HOPE Therapeutics, Inc.
mduffy@nrxpharma.com
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SOURCE NRx Pharmaceuticals, Inc.
$NRXP - A recent article details NRX-100 the proprietary, preservative-free formulation of IV ketamine that the company is submitting to regulators as a treatment for suicidal depression.
https://psychiatrist.com/news/nrx-100s-breakthrough-in-suicidality-treatment/
#PharmaNews #ketamine #PTSD #bipolar #clinic #NRX100 #NRXPharma $NRXP
A recent article details NRX-100 the proprietary, preservative-free formulation of IV ketamine that the company is submitting to regulators as a treatment for suicidal depression.https://t.co/8tRpKEibLV#PharmaNews #ketamine #PTSD #bipolar #clinic #NRX100 #NRXPharma $NRXP
— NRx Pharmaceuticals (@NRxPharma) April 7, 2025
$NRXP Saving Lives! NRx Pharma has recently initiated a New Drug Application filing for NRX-100 (IV ketamine) for the treatment of suicidal depression.
#PressRelease HOPE Therapeutics, Inc. and NRx Pharmaceuticals, Inc. (NASDAQ: $NRXP) Announce Signing of a Term Sheet for Strategic Investment from a Global Medical Device Manufacturer into HOPE
#PressRelease HOPE Therapeutics, Inc. and NRx Pharmaceuticals, Inc. (NASDAQ: $NRXP) Announce Signing of a Term Sheet for Strategic Investment from a Global Medical Device Manufacturer into HOPE https://t.co/NoQcdVor9x $AMOD $ASTI $CBDW $CYCU $IQST $ONAR $RMXI $VSEE $ILLR $TMGI… pic.twitter.com/iKR2I9AvHQ
— Stocks On High ALertđź’Ż (@StockOnHighALer) April 3, 2025
$NRXP News: HOPE Therapeutics, Inc. and NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Announce Signing of a Term Sheet for Strategic Investment from a Global Medical Device Manufacturer into HOPE
Investment to support initiation of HOPE's network of clinics to treat suicidal depression and PTSD with ketamine, TMS and other modalities
MIAMI, April 3, 2025 /PRNewswire/ -- HOPE Therapeutics, Inc., ("HOPE," the "Company"), an interventional psychiatry network wholly owned by NRx Pharmaceuticals, Inc. ("NRx") (Nasdaq:NRXP), today 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 HOPE's vision of providing comprehensive interventional psychiatry treatments to patients around the world.
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 (the "Series A Preferred") at a $50 million pre-money valuation. The terms of the Series A Preferred will be defined in a Certificate of Designation to be filed with the State of Delaware, and expected to provide for, among other things, a dividend based on current market conditions and the right to appoint a director to HOPE's Board. The pre-money valuation shall be subject to future adjustment based on actual Earnings Before Interest, Taxes, Depreciation, and Amortization (EBITDA) for the third quarter ended September 30, 2026.
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.
"As identified in our recent annual report and in recently published independent research reports, we continue to execute on our strategy to combine already-profitable, best-in-class interventional psychiatry clinics to serve the extraordinary unmet need of patients with severe depression and PTSD," said Jonathan Javitt, MD, MPH, and Matthew Duffy, co-CEO's of HOPE Therapeutics.
About HOPE Therapeutics, Inc.
HOPE Therapeutics, Inc. (www.hopetherapeutics.com) is a healthcare delivery company currently developing a best-in-class network of interventional psychiatry clinics to offer psychedelic medications, including ketamine and Spravato®, combined with Transcranial Magnetic Stimulation (TMS) and other lifesaving, neuroplastic 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.
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 recently announced initiation of filing a New Drug Application 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 data sharing agreements. 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.
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. These statements include, among others, statements regarding the satisfaction of closing conditions necessary to consummate the acquisition of Kadima, Neurospa and Dura, and obtaining financing necessary to consummate the acquisitions. 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, 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 http://www.sec.gov. 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.
For further information:
Matthew Duffy
Co-Chief Executive Officer, HOPE Therapeutics, Inc.
Chief Business Officer, NRx Pharmaceuticals, Inc.
mduffy@nrxpharma.com
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SOURCE NRx Pharmaceuticals, Inc.
$NRXP News: HOPE Therapeutics, Inc. and NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Announce Definitive Purchase Agreement with Dura Medical; Initial Acquisition for Planned International Network of Interventional Psychiatry Clinics
PR Newswire
Mon, March 31, 2025 at 8:02 AM EDT
In This Article: NRXP, NRXPW
Dura Medical, together with previously-announced acquisition of Neurospa TMS, will provide coverage throughout the West Coast of Florida
Delivers a full range of precision psychiatry services for severe depression and PTSD, including Ketamine Therapy and Transcranial Magnetic Stimulation (TMS), to veteran and civilian patients
Stephen Durand, founder of Dura, to serve as Director of Clinic Operations for HOPE in Florida
MIAMI, March 31, 2025 /PRNewswire/ -- HOPE Therapeutics, Inc., ("HOPE," the "Company"), an interventional psychiatry network wholly owned by NRx Pharmaceuticals, Inc. ("NRx") (Nasdaq: NRXP), today announced signing of a definitive Agreement to acquire Dura Medical (Dura), per the previously announced non-binding Letter of Intent. Dura, together with the previously announced Neurospa network, are anticipated to provide a comprehensive service offering to patients on Florida's west coast. Dura is revenue generating and EBITDA positive.
(PRNewsfoto/NRx Pharmaceuticals)
(PRNewsfoto/NRx Pharmaceuticals)
Dura Medical was founded in 2018 to offer a gold-standard, precision approach to treating mental health and chronic pain on the west coast of Florida. The clinics leverage the latest interventional psychiatry procedures, including Ketamine Infusion Therapy, Transcranial Magnetic Stimulation (TMS), Spravato® and Stellate Ganglion Blocks, augmented by traditional psychiatry and therapy to provide a full continuum of care for people with depression, suicidality, PTSD, anxiety, and related disorders.
A US Army Reserve Veteran, Mr. Durand and Dura Medical are proud to provide for the Veterans Affairs Community Cares Network (VA CCN) under an agreement with the US Department of Veterans Affairs to ensure that military veterans have full access to Ketamine Infusion Therapy, TMS and Spravato®, in addition to Traumatic Incident Reduction Therapy (TIR).
In conjunction with the planned acquisition, HOPE is honored to appoint Mr. Durand as Director of Florida Clinic Operations.
"We founded Dura Medical with the mission to reduce suicide in our community and aim to treat more than 10,000 people by 2026. We're excited to align mission with the HOPE Network and to lead HOPE's expansion in Florida and beyond," said Stephen Durand, Founder of Dura Medical.
"Steve Durand has been a pioneer in combining the use of psychedelic medications with neuroplastic technologies, including TMS in the treatment of suicidal depression and PTSD. We are excited to incorporate Dura's tradition of excellence and commitment to patient care for civilians and veterans alike into HOPE's Florida network, " said Jonathan Javitt, MD MPH and Matthew Duffy, Co-CEOs of HOPE Therapeutics. "Mr. Durand will coordinate closely with Dr. Dennis McBride, PhD (CAPT US Navy Ret., SES-4 National Defense University Ret.) our Chief Strategy Officer and Mr. Thomas Paul (1SG US Army Ret), recently of the 82nd Airborne, HOPE's Chief of Staff.
The intended closing of the of Dura acquisition is subject to completion of financial audits, regulatory approvals, and the satisfaction of standard closing conditions.
About HOPE Therapeutics, Inc.
HOPE Therapeutics, Inc. (www.hopetherapeutics.com) is a healthcare delivery company currently developing a best-in-class network of interventional psychiatry clinics to offer psychedelic medications, including ketamine and Spravato®, combined with Transcranial Magnetic Stimulation (TMS) and other lifesaving, neuroplastic 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.
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 recently announced initiation of filing a New Drug Application 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 data sharing agreements. 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.
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. These statements include, among others, statements regarding the satisfaction of closing conditions necessary to consummate the acquisition of Kadima, Neurospa and Dura, and obtaining financing necessary to consummate the acquisitions. 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, 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 http://www.sec.gov. 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.
For further information:
Matthew Duffy
Co-Chief Executive Officer, HOPE Therapeutics, Inc.
Chief Business Officer, NRx Pharmaceuticals, Inc.
mduffy@nrxpharma.com
View original content to download multimedia:https://www.prnewswire.com/news-releases/hope-therapeutics-inc-and-nrx-pharmaceuticals-inc-nasdaqnrxp-announce-definitive-purchase-agreement-with-dura-medical-initial-acquisition-for-planned-international-network-of-interventional-psychiatry-clinics-302415522.html
SOURCE NRx Pharmaceuticals, Inc.
Good morning $NRXP Pharma news out to start the week!
$NRXP News: "Here's Why NRx Pharmaceuticals (NRXP) Is a Great 'Buy the Bottom' Stock Now"
Zacks Equity Research
Thu, March 27, 2025
Shares of NRx Pharmaceuticals, Inc. (NRXP) have been struggling lately and have lost 5.1% over the past week. However, a hammer chart pattern was formed in its last trading session, which could mean that the stock found support with bulls being able to counteract the bears. So, it could witness a trend reversal down the road.
The formation of a hammer pattern is considered a technical indication of nearing a bottom with likely subsiding of selling pressure. But this is not the only factor that makes a bullish case for the stock. On the fundamental side, strong agreement among Wall Street analysts in raising earnings estimates for this company enhances its prospects of a trend reversal.
1-month candlestick chart for NRXP
Understanding Hammer Chart and the Technique to Trade It
This is one of the popular price patterns in candlestick charting. A minor difference between the opening and closing prices forms a small candle body, and a higher difference between the low of the day and the open or close forms a long lower wick (or vertical line). The length of the lower wick being at least twice the length of the real body, the candle resembles a 'hammer.'
In simple terms, during a downtrend, with bears having absolute control, a stock usually opens lower compared to the previous day's close, and again closes lower. On the day the hammer pattern is formed, maintaining the downtrend, the stock makes a new low. However, after eventually finding support at the low of the day, some amount of buying interest emerges, pushing the stock up to close the session near or slightly above its opening price.
When it occurs at the bottom of a downtrend, this pattern signals that the bears might have lost control over the price. And, the success of bulls in stopping the price from falling further indicates a potential trend reversal.
Hammer candles can occur on any timeframe -- such as one-minute, daily, weekly -- and are utilized by both short-term as well as long-term investors.
Like every technical indicator, the hammer chart pattern has its limitations. Particularly, as the strength of a hammer depends on its placement on the chart, it should always be used in conjunction with other bullish indicators.
Here's What Increases the Odds of a Turnaround for NRXP
An upward trend in earnings estimate revisions that NRXP has been witnessing lately can certainly be considered a bullish indicator on the fundamental side. That's because empirical research shows that trends in earnings estimate revisions are strongly correlated with near-term stock price movements.
Over the last 30 days, the consensus EPS estimate for the current year has increased 25%. What it means is that the sell-side analysts covering NRXP are majorly in agreement that the company will report better earnings than they predicted earlier.
If this is not enough, you should note that NRXP currently has a Zacks Rank #2 (Buy), which means it is in the top 20% of more than the 4,000 stocks that we rank based on trends in earnings estimate revisions and EPS surprises. And stocks carrying a Zacks Rank #1 or 2 usually outperform the market. You can see the complete list of today's Zacks Rank #1 (Strong Buy) stocks here >>>>
Moreover, a Zacks Rank of 2 for NRx Pharmaceuticals is a more conclusive indication of a potential trend reversal, as the Zacks Rank has proven to be an excellent timing indicator that helps investors identify precisely when a company's prospects are beginning to improve.
Article buy Zacks Investment Research- https://finance.yahoo.com/news/heres-why-nrx-pharmaceuticals-nrxp-135503641.html?soc_src=social-sh&soc_trk=tw&tsrc=twtr
$NRXP Update: NRx Pharmaceuticals is focused on the high unmet need for lifesaving treatments for people with severe bipolar depression and PTSD in the presence of suicidality.
Follow our journey.
http://NRxPharma.com
#ketamine #PTSD #bipolar #NRX100 #NRX101 $NRXP
Good morning. Nice update out for $NRXP!
$NRXP -$300 Million in Milestones; Double-Digit Royalties; LOI with Neurospa for Expansion of International Psychiatry Clinics; NDA Filed with FDA on New Drug: NRx Pharmaceuticals: (Stock Symbol: $NRXP) -
@APNews
Read More- https://apnews.com/press-release/getnews/clinical-trials-medication-u-s-food-and-drug-administration-florida-miami-5ee37cc921b2cb8f8e873d270854cd58
#PharmaNews #ketamine #MentalHealth
$300 Million in Milestones; Double-Digit Royalties; LOI with Neurospa for Expansion of International Psychiatry Clinics; NDA Filed with FDA on New Drug: NRx Pharmaceuticals: (Stock Symbol: $NRXP) - @APNews
— NRx Pharmaceuticals (@NRxPharma) March 26, 2025
Read More- https://t.co/qgHSRi3O2g#PharmaNews #ketamine #MentalHealth
$NRXP: New analyst report from D. Boral Capital - HOPE Therapeutics Expands Psychiatry Network
New analyst report from D. Boral Capital - HOPE Therapeutics Expands Psychiatry Network
— NRx Pharmaceuticals (@NRxPharma) March 25, 2025
Read Report- https://t.co/OPAGoUiBDg #PharmaNews #mentalillness #mentalhealth #depression #ketamine #stress #PTSD #bipolar #psychiatry #healthcare #clinic #NRXPharma #hopetherapeutics $NRXP pic.twitter.com/wqwDi1hDQA
$NRXP -HOPE Therapeutics, Inc. and NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Announce Signing of Binding Letter of Intent with Neurospa TMS Holdings, LLC for Expansion of its Planned International Network of Interventional Psychiatry Clinics
PR Newswire
Mon, March 24, 2025 at 8:02 AM EDT
In This Article:
NRXP
NRXPW
Neurospa currently operates six interventional psychiatry clinics on Florida's Gulf Coast
HOPE to acquire majority interest in Neurospa for a combination of cash and equity
Neurospa clinics deliver a full range of interventional psychiatry services, including Ketamine, Spravato® and Transcranial Magnetic Stimulation (TMS) to patients with severe depression and related conditions
Acquisition to be accretive to HOPE revenue projections for 2025
MIAMI, March 24, 2025 /PRNewswire/ -- HOPE Therapeutics, Inc., ("HOPE," the "Company"), an interventional psychiatry network wholly owned by NRx Pharmaceuticals, Inc. ("NRx") (Nasdaq:NRXP), today announced signing of a binding Letter of Intent to acquire a majority interest in Neurospa TMS Holdings, LLC, LLC (Neurospa). 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.
HOPE Therapeutics, Inc. (PRNewsfoto/NRx Pharmaceuticals, Inc.)
HOPE Therapeutics, Inc. (PRNewsfoto/NRx Pharmaceuticals, Inc.)
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.
Neurospa provides a physician-led, welcoming spa-like environment that puts patient's needs and comfort first. Neurospa's outstanding team of dedicated professionals are to become key members of the HOPE team upon closing of the transaction.
"Neurospa was founded with the mission to provide TMS therapy for patients in the Tampa Bay area, and has grown to provide comprehensive, cutting-edge care to patients in our six clinics in west central Florida; the team has made great progress achieving this exceptional level of care. We're eager to accelerate that mission by joining the HOPE Network," said Renier Gobea, Founder of Neurospa.
"We are thrilled to welcome the Neurospa team to the HOPE network and look forward to the contribution they will continue to make to their patients and to the expansion of the HOPE network statewide," said Jonathan Javitt, MD MPH and Matthew Duffy, Co-CEOs of HOPE Therapeutics.
The intended acquisition of Neurospa is subject to the completion of financial audits, execution of definitive agreements, and the satisfaction of standard closing conditions.
About HOPE Therapeutics, Inc.
HOPE Therapeutics, Inc. (www.hopetherapeutics.com) is a healthcare delivery company currently developing a best-in-class network of interventional psychiatry clinics to offer psychedelic medications, including ketamine and Spravato®, combined with Transcranial Magnetic Stimulation (TMS) and other lifesaving, neuroplastic 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.
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 recently announced initiation of filing a New Drug Application 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 data sharing agreements. 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.
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. These statements include, among others, statements regarding the satisfaction of closing conditions necessary to consummate the acquisition of Kadima, Neurospa and Dura, and obtaining financing necessary to consummate the acquisitions. 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, 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 http://www.sec.gov. 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.
For further information:
Matthew Duffy
Co-Chief Executive Officer, HOPE Therapeutics, Inc.
Chief Business Officer, NRx Pharmaceuticals, Inc.
mduffy@nrxpharma.com
$NRXP PT of $5 short term is reasonable especially if shorts cover on news. $19 long term is legit especially with the research provided.
$NRXP $2.2500 +3.21% -Making a nice move Pre-market on news!
$NRXP News: NRX Pharmaceuticals (NRXP) H.C. Wainwright reiterated a Buy rating on NRX Pharmaceuticals today and set a price target of $19.00. The company’s shares closed last Wednesday at $2.18. https://www.tipranks.com/news/blurbs/analysts-top-healthcare-picks-nrx-pharmaceuticals-nrxp-alcon-alc?mod=mw_quote_news
$NRXP -NRX Pharmaceuticals Inc (NRXP) Q4 2024 Earnings Call Highlights: Strategic Moves and Financial Highlights
GuruFocus News
Tue, March 18, 2025 at 3:01 AM EDT
In This Article:
NRXP
+2.91%
NRXPW
+49.38%
Loss from Operations: Reduced by approximately $9.3 million, or 33.5%, to $18.5 million for the year ended December 31, 2024.
Research and Development Expense: Decreased by approximately $7.2 million, or 53.6%, to $6.2 million for the year ended December 31, 2024.
General Administrative Expense: Decreased by approximately $7.7 million to $13.5 million for the year ended December 31, 2024.
Cash and Cash Equivalents: Approximately $1.4 million as of December 31, 2024.
Recent Financing: Completed two financings in January 2025 with aggregate gross proceeds of approximately $8.5 million.
Warning! GuruFocus has detected 2 Warning Signs with NRXP.
Release Date: March 17, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
NRX Pharmaceuticals Inc (NASDAQ:NRXP) has raised new capital and retired toxic debt, positioning itself for potential profitability by the end of 2025.
The company has initiated the filing of a New Drug Application (NDA) for NRX-100, a preservative-free intravenous ketamine, supported by stability data and manufacturing capacity for over 1 million doses per month.
NRX Pharmaceuticals Inc (NASDAQ:NRXP) has received a strategic term sheet for NRX-100, valued at over $300 million in milestones and double-digit royalties, validating their drug development approach.
The company is preparing an accelerated NDA filing for NRX-101, a combination of D-cycloserine and lurasidone, with a potential market exceeding $5 billion.
HOPE Therapeutics, a subsidiary of NRX Pharmaceuticals Inc (NASDAQ:NRXP), is expanding its network of interventional psychiatry clinics, with plans to acquire profitable clinics and generate substantial revenue growth.
Negative Points
NRX Pharmaceuticals Inc (NASDAQ:NRXP) faces challenges in the capital market environment, which has been less supportive of pre-revenue biotechnology companies.
The safety of repeated ketamine use is a concern, with potential toxicity from the preservative benzethonium chloride, leading to a citizen's petition to the FDA.
The company has only $1.4 million in cash and cash equivalents as of December 31, 2024, raising concerns about its financial stability.
The acquisition of clinics involves complex legal and regulatory processes, which could delay the expansion of HOPE Therapeutics.
NRX Pharmaceuticals Inc (NASDAQ:NRXP) is reliant on securing commercial partnerships and financing to support its growth and drug development initiatives.
Q & A Highlights
Q: Jonathan, you made a good argument for removing the preservative from ketamine. If you remove the preservative for ketamine, how does that change the formulation? And for example, what do you do in its place? A: The preservative was originally added to ketamine for multi-use vials to prevent contamination. However, with single-use vials, a preservative is not needed. We've found that preservative-free ketamine can maintain stability and sterility, allowing us to file for two-year shelf stability at room temperature.
Q: Can you talk a little bit about the acquisition strategy to add more clinics this year and what we should expect a year from now? A: Florida is a focus due to clinics already doing it right. Many clinics offer ketamine alongside other treatments, but few integrate it with neuromodulatory technology like TMS. We're working with BTIG to identify and acquire clinics that meet our standards, aiming to build a nationwide network.
Q: In the press release, you talk about a potential ketamine deal with $300 million in milestones and tiered royalties. Can you expand on that? A: As we approach having a marketable drug, commercial partners are showing interest. While a deal is never done until it's done, having a partner with an existing sales force could be more attractive than launching the drug ourselves.
Q: Regarding the ketamine clinic landscape in Florida, is it chunky? Should we look for acquisitions to happen in big chunks? A: Yes, acquisitions will generally represent more than one clinic at a time. While Kadima is a single-site facility, most clinics doing it well operate multiple locations, which will be part of our acquisition strategy.
Q: Regarding the terms with the commercial pharmaceutical company for NRX-100, do you anticipate a second-quarter announcement for the finalization of the deal? A: We hope it may be finalized in the second quarter, but a deal is never done until it's done. We have the resources to continue moving forward without a commercial deal, but we welcome the right partner.
Q: How easy would it be for a competitor to make their own single-use presentations of ketamine for intravenous use? A: Competitors would face challenges, including developing a preservative-free formulation with stability. While we may not have the market to ourselves long-term, our formulation could provide a competitive advantage if it stands up to patent review.
Q: As you may potentially have NRX-100 and NRX-101 approval this year with the FDA, have you thought about international plans for both? A: We've developed relationships in France, where there's a significant focus on suicidal depression. A European filing could resonate throughout Europe, and we expect increased interest from Asia-Pacific entities as we gain momentum.
Q: How does HOPE directly benefit NRx shareholders? A: HOPE is an asset on the NRx balance sheet, and its profits will benefit NRx shareholders. We plan to spin out HOPE shares to NRx stockholders, ensuring any success of HOPE benefits NRx investors.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
This article first appeared on GuruFocus.
"Our work in the fourth quarter of 2024 and into 2025 has driven significant advances for our company and investors. We have retired debt that was impeding the launch of HOPE Therapeutics and brought new investors into the Company who are aligned with our objectives. We launched the filing of a New Drug Application for NRX-100 for the treatment of Suicidal Depression: a major milestone for NRx. We also moved NRX-101 toward it's NDA for Accelerated Approval in bipolar depression in patients at risk of akathisia, and made meaningful progress building HOPE's best-in-class network of Interventional Psychiatry Clinics. Additionally, two potential strategic transactions that are under negotiation could further accelerate our progress. These accomplishments advance our mission of preventing and treating suicide: work that is critical to our patients, their families and our country," said Jonathan Javitt, MD, MPH, Chairman, and CEO of NRx Pharmaceuticals. "I would like to thank our team for its dedication and hard work, and thank our shareholders for their ongoing support of our mission to bring hope to life." $NRXP
Looks like big money is ahead for NRXP. Note from today's very impressive and detailed press release:
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The Company 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 News: NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update
PR Newswire
Mon, March 17, 2025 at 8:02 AM EDT
In This Article:
NRXP
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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
The Company 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
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
HOPE Therapeutics, a wholly owned subsidiary of NRx, 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
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.
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
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
WILMINGTON, Del., March 17, 2025 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced its financial results for the quarter and year ended December 31, 2024, and provided a business update.
(PRNewsfoto/NRx Pharmaceuticals)
(PRNewsfoto/NRx Pharmaceuticals)
"Our work in the fourth quarter of 2024 and into 2025 has driven significant advances for our company and investors. We have retired debt that was impeding the launch of HOPE Therapeutics and brought new investors into the Company who are aligned with our objectives. We launched the filing of a New Drug Application for NRX-100 for the treatment of Suicidal Depression: a major milestone for NRx. We also moved NRX-101 toward it's NDA for Accelerated Approval in bipolar depression in patients at risk of akathisia, and made meaningful progress building HOPE's best-in-class network of Interventional Psychiatry Clinics. Additionally, two potential strategic transactions that are under negotiation could further accelerate our progress. These accomplishments advance our mission of preventing and treating suicide: work that is critical to our patients, their families and our country," said Jonathan Javitt, MD, MPH, Chairman, and CEO of NRx Pharmaceuticals. "I would like to thank our team for its dedication and hard work, and thank our shareholders for their ongoing support of our mission to bring hope to life."
Key Research and Development and Corporate Activities
NRX-100 (IV, preservative-free ketamine)
According to the CDC, more than 13 million adults contemplate suicide each year; NRX-100 – IV ketamine for Suicidal Depression - can help address this national crisis.
The Company 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 >$3 billion Suicidal Depression market in the US.
The Company 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.
In December 2024 the company demonstrated long term stability and sterility of a patentable formulation of preservative-free ketamine, despite longstanding commercial practice of adding benzethonium chloride as a preservative to commercially supplied ketamine. This preservative is a known caustic and toxic substance that has previously demonstrated corneal neurotoxicity and conjunctival toxicity in patients, and generalized neurotoxicity in the laboratory at microgram concentrations. The concentration in current ketamine preparations is substantially higher, with an extensive body of scientific literature documenting concern. Additionally, chronic administration of ketamine is known to increase the risk of cystitis ( Ref ); the relationship of this adverse event to benzethonium chloride is unknown. Now that a long-term stable and sterile preservative-free formulation is available, the Company is filing a citizens petition to seek removal of benzethonium chloride from the human and veterinary ketamine drug supply.
The Company believes that the preservative-free feature of NRX-100 will be deemed of benefit to patients and is consistent with evolving federal policy on toxic preservatives in the US food and drug supply chain. Therefore, in addition to the NDA designed to add treatment of depression to the current ketamine label, the Company plans to file an Abbreviated New Drug Application ("ANDA") in the second quarter of 2025 for the use of preservative-free ketamine in all currently indicated human and veterinary applications. The Company believes it has met all requirements of the ANDA approval process, has demonstrated manufacturing capacity in excess of one million vials per month, and is prepared to supply the broad ketamine market.
As a next-generation product, the Company has developed a novel, patentable pH neutral formulation of ketamine (designed as HTX-100) based on a proprietary excipient that overcomes ketamine's insolubility, that will be suitable for both intravenous and subcutaneous administration. Initial laboratory lots demonstrate shelf stability and ongoing stability is being assessed. Ketamine in its current commercial presentations cannot be administered subcutaneously because of its high acidic (pH 3.5-4.0) properties, an acidity range that is known to cause pain and skin ulcers. This product is expected to undergo clinical testing in 2025/2026 and be ready for FDA approval in late 2026. Oral forms of ketamine and intranasal racemic ketamine have failed to demonstrate sufficiently stable blood levels to replace intravenous ketamine. However, a ketamine formulation capable of achieving clinical benefit via subcutaneous use – in the manner that diabetes drugs are currently administered – could facilitate far broader clinical use of ketamine to treat life-threatening CNS diseases.
The Company has retained a leading regulatory law firm to file the citizen's petition with the US Food and Drug Administration to remove benzethonium chloride, a known neurotoxic substance, from presentations of ketamine intended for intravenous use. The Company believes that the preservative-free feature of NRX-100 will be deemed of benefit to patients because of the known toxicity of benzethonium chloride in current generic products.
NRX-101 (oral D-cycloserine/lurasidone)
Bipolar depression affects approximately seven million people in the US. Current treatment options all carry the risk of suicide and akathisia, a side-effect of serotonin active antidepressants which is closely related to suicide. People with bipolar depression and akathisia or suicidality are at imminent risk of self-harm. These patients need better treatment options urgently.
The Company announced its intention to file 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, based on the Phase 2b/3 and STABIL-B data. Three manufacturing lots are now complete with more than 12 months of room temperature shelf-stability. The anticipated PDUFA date for this application is prior to December 31, 2025.
The Company estimates that the market for the initial indication is over $2 billion, while the broad bipolar market could exceed $5 billion.
HOPE Therapeutics
HOPE Therapeutics, a wholly owned subsidiary of NRx Pharmaceuticals, is developing a new clinical paradigm for the treatment of depression, PTSD, obsessive-compulsive disorder, and related CNS conditions. While there is clinical evidence that NMDA-targeted drugs such as NRX-100 and NRX-101 have the potential to offer clinical benefit, many patients additionally require neuromodulatory techniques, such as Transcranial Magnetic Stimulation ("TMS"), digital therapeutics, traditional psychotherapy and medication management to achieve long-term remission from suicidal depression and PTSD. Despite the proliferation of "ketamine clinics" in the US, few psychiatrist-led entities are successful in offering a comprehensive solution to patients and families.
During the second half of 2024, the Company began outlining the plan for HOPE Therapeutics as a national and ultimately international network of Interventional Psychiatry centers that will combine NMDA-targeted and future psychedelic drugs with neuroplastic treatments in an integrated and reproducible manner. The business model for HOPE Therapeutics is similar to that of leading national dialysis providers, companies that were instrumental in making kidney dialysis reliable and reproducible in a manner that transformed the industry and routinely trade at double digit P/E multiples.
In 2024, the Company announced a non-binding Letter of Intent to acquire Kadima, LLC, a pioneering interventional psychiatry clinic in La Jolla, CA. Kadima's founder, Dr. David Feifel agreed to serve as HOPE's Chief Medical Innovation Officer post-acquisition. He is one of the first academic psychiatrists to move ketamine and TMS therapy to the community care model and was recently featured on Dr. Sanjay Gupta's broadcast entitled "The Wild West of Ketamine Treatment" as an advocate for how ketamine therapy can be delivered reliably and responsibly. Link: Wild West of Ketamine.
Subsequent to the Kadima commitment, the Company has, or anticipates, contracting to acquire and/or partner with eight facilities in Florida, aiming for 15-20 facilities in Florida by year-end 2025.
The clinical centers that are being incorporated in the 2025 acquisition program are currently operating and profitable centers that the Company believes can experience substantial revenue growth through the addition of a broader array of comprehensive services. Management estimates that the acquisition of 20 clinic networks, each with current revenue of approximately $5 million will be required to meet its 2025 growth target.
Financings
The Company has consummated a series of financing agreements with an institutional investor for up to $16.3 million in debt capital, for which we closed on $10.9 million in 2024 and subsequently closed $8.5 million in a combination of convertible debt and an above-market common stock and warrant offering in January 2025. Subsequently, we terminated a planned $2 million investment from a smaller fund with less favorable terms.
The Company has also received and is currently negotiating a term sheet with a publicly-traded entity engaged in the manufacture of FDA-cleared devices for Transcranial Magnetic Stimulation to provide acquisition capital to support the expansion of HOPE Therapeutics clinics. In addition, it is negotiating with several commercial lenders to support expansion of HOPE clinics with standard commercial loans. Although business plans are subject to change, assuming consummation of the financings on terms currently contemplated by management, the Company would achieve its objective of financing less than 50% of the proposed acquisition costs, thereby enabling the Company to optimize its cost of acquisition capital as it expands the HOPE clinic network.
Our current financing activities are intended to supplant the previously announced equity investment in HOPE on more favorable terms.
Financial Results for the Quarter and Year Ended December 31, 2024
For the three months ended December 31, 2024, NRx Pharmaceuticals reduced its loss from operations by approximately $2.0 million to $2.4 million from $4.4 million in the fourth quarter of 2023, representing nearly a 45% improvement quarter over quarter primarily driven by lower research and development costs and a settlement gain, which were partially offset by an increase in general and administrative expense. For the three months ended December 31, 2024, research and development expense decreased by approximately $1.5 million to $1.0 million as compared to $2.5 million during the fourth quarter ended December 31, 2023. The $1.5 million decrease is primarily related to a decrease in clinical trial and development expense due to the conclusion of the phase 2b/3 study for NRX-101. Finally, general and administrative expense for the three month period ended December 31, 2024 increased by approximately $0.7 million to $2.6 million as compared to approximately $1.9 million for the three month period ended December 31, 2023, which was primarily driven by higher consulting fees related to the potential acquisition of several psychiatry clinics in support of the growth model for HOPE Therapeutics.
For the year ended December 31, 2024, NRx Pharmaceuticals reduced its loss from operations by approximately $9.3 million, or 33.5%, to $18.5 million from $27.8 million for the year ended December 31, 2023, which was primarily driven by a decrease in research and development expense. For the year ended December 31, 2024, research and development expense decreased by approximately $7.2 million, or 53.6%, to $6.2 million as compared to $13.4 million for the year ended December 31, 2023 primarily driven by a decrease in clinical trial and development expense due to the conclusion of the phase 2b/3 study for NRX-101. Finally, general and administrative expense for the year ended December 31, 2024 decreased by approximately $0.7 million to $13.5 million as compared to $14.2 million for the year ended December 31, 2023 primarily driven by a reduction in insurance and employee costs, and partially offset by an increase in consulting fees related to the potential acquisition of several psychiatry clinics in support of the growth model for HOPE Therapeutics.
As of December 31, 2024, we had approximately $1.4 million in cash and cash equivalents. As noted above, in January 2025, the Company completed two financings with aggregate gross proceeds of approximately $8.5 million. Management believes that current available cash resources will be sufficient to support ongoing operations through at least the end of 2025.
NRx continues to implement operational efficiencies to extend cash runway and maintain focus on our path to generating revenue and value for our shareholders.
Please see detailed financials on our Form 10-K, filed with the SEC and available on our website.
Conference Call and Webcast Details
A live webcast of the conference call will be available on the Company's website at 8:30 a.m. ET Monday March 17, 2025, at https://ir.nrxpharma.com/events. An archive of the webcast will be available on the Company's website for 30 days. 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. (www.hopetherapeutics.com) 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 http://www.sec.gov. 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.
For further information:
Matthew Duffy
Chief Business Officer, NRx Pharmaceuticals
Co-Chief Executive Officer, HOPE Therapeutics, Inc.
mduffy@nrxpharma.com
Good morning $NRXP Happy St. Patrick's Day!
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