NRx Pharmaceuticals (NASDAQ:NRXP) Completes Memorandum of Understanding and Collaborations with Distribution Partners for HTX-100 (IV Ketamine)
Company to receive first allocation of ketamine for sale by month end
Partners preparing to ship IV Ketamine to full range of customers via 503a and 503b pharmacies
NRx Pharmaceuticals and HOPE Therapeutics aim to provide highest quality product available to those in need and assure ongoing supply
Important step toward goal of providing full suite of supply options, to ultimately include an FDA approved, and widely reimbursed, solution for patients and clinics, subject to board approval
RADNOR, Pa., March 11, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"
and its wholly owned subsidiary HOPE Therapeutics, clinical-stage biopharmaceutical companies, today announced completion of a Memorandum of Understanding with Conversio Health, a national 503a pharmacy, and a strong, ongoing partnership with Nephron Pharmaceuticals, a manufacturer of Ketamine and 503b pharmacy to provide IV Ketamine to patients and clinics across the country, subject to board approval. These are important steps to providing a full suite of ketamine options for customers across the country, and preparation for potential approval of HTX-100 by regulatory authorities worldwide.
(PRNewsfoto/NRx Pharmaceuticals)
(PRNewsfoto/NRx Pharmaceuticals)
The Company has further entered into a business relationship with an organization that currently serves the business needs of more than 100 ketamine clinics nationwide. The Company has been given a target delivery date prior to the end of this month (March 2024) for initial stock of ketamine for sale to licensed end users. Sales are planned to commence once technical and logistical elements are finalized. Details for ordering will be available on our website as soon as they are available. www.hopetherapeutics.com
In contrast to NRx Pharmaceuticals, which is structured as a Biotechnology research and development company, HOPE Therapeutics is structured as a Specialty Pharmaceutical company that aims to supply a variety of therapeutic products to clinics that are treating suicidal depression and PTSD, including both traditional and digital therapeutics.
"We are pleased to be working with two outstanding organizations in Conversio Health and Nephron Pharmaceuticals to provide this important medication to a market in need of a consistent supply of high-quality, FDA- and DEA- compliant IV ketamine," said Matthew Duffy Chief Business Officer of NRx Pharmaceuticals and co-CEO of HOPE Therapeutics. "Importantly, these efforts will provide a strong foundation for expanding our product offering with our planed filing a New Drug Application with the FDA in the coming months, and the potential launch of HTX-100 in early 2025." The NDA filing currently awaits completion of an additional three months of product stability.
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 has partnered with Alvogen and Lotus around the development and marketing of NRX-101 for the treatment of suicidal bipolar depression. NRX-101 additionally has potential to act as a non-opioid treatment for chronic pain, as well as a treatment for complicated UTI.
NRx has recently announced plans to submit a New Drug Application for HTX-100 (IV ketamine), through HOPE Therapeutics, in the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreement. 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 Specialty Pharmaceutical Company, wholly-owned by NRX Pharmaceuticals focused on development and marketing of an FDA-approved form of intravenous ketamine for the treatment of acute suicidality and depression 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 proposed public offering and the timing and the use of the proceeds from the offering. 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 and 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.
Cision
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SOURCE NRx Pharmaceuticals, Inc.
Company to receive first allocation of ketamine for sale by month end
Partners preparing to ship IV Ketamine to full range of customers via 503a and 503b pharmacies
NRx Pharmaceuticals and HOPE Therapeutics aim to provide highest quality product available to those in need and assure ongoing supply
Important step toward goal of providing full suite of supply options, to ultimately include an FDA approved, and widely reimbursed, solution for patients and clinics, subject to board approval
RADNOR, Pa., March 11, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"
and its wholly owned subsidiary HOPE Therapeutics, clinical-stage biopharmaceutical companies, today announced completion of a Memorandum of Understanding with Conversio Health, a national 503a pharmacy, and a strong, ongoing partnership with Nephron Pharmaceuticals, a manufacturer of Ketamine and 503b pharmacy to provide IV Ketamine to patients and clinics across the country, subject to board approval. These are important steps to providing a full suite of ketamine options for customers across the country, and preparation for potential approval of HTX-100 by regulatory authorities worldwide. (PRNewsfoto/NRx Pharmaceuticals)
(PRNewsfoto/NRx Pharmaceuticals)
The Company has further entered into a business relationship with an organization that currently serves the business needs of more than 100 ketamine clinics nationwide. The Company has been given a target delivery date prior to the end of this month (March 2024) for initial stock of ketamine for sale to licensed end users. Sales are planned to commence once technical and logistical elements are finalized. Details for ordering will be available on our website as soon as they are available. www.hopetherapeutics.com
In contrast to NRx Pharmaceuticals, which is structured as a Biotechnology research and development company, HOPE Therapeutics is structured as a Specialty Pharmaceutical company that aims to supply a variety of therapeutic products to clinics that are treating suicidal depression and PTSD, including both traditional and digital therapeutics.
"We are pleased to be working with two outstanding organizations in Conversio Health and Nephron Pharmaceuticals to provide this important medication to a market in need of a consistent supply of high-quality, FDA- and DEA- compliant IV ketamine," said Matthew Duffy Chief Business Officer of NRx Pharmaceuticals and co-CEO of HOPE Therapeutics. "Importantly, these efforts will provide a strong foundation for expanding our product offering with our planed filing a New Drug Application with the FDA in the coming months, and the potential launch of HTX-100 in early 2025." The NDA filing currently awaits completion of an additional three months of product stability.
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 has partnered with Alvogen and Lotus around the development and marketing of NRX-101 for the treatment of suicidal bipolar depression. NRX-101 additionally has potential to act as a non-opioid treatment for chronic pain, as well as a treatment for complicated UTI.
NRx has recently announced plans to submit a New Drug Application for HTX-100 (IV ketamine), through HOPE Therapeutics, in the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreement. 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 Specialty Pharmaceutical Company, wholly-owned by NRX Pharmaceuticals focused on development and marketing of an FDA-approved form of intravenous ketamine for the treatment of acute suicidality and depression 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 proposed public offering and the timing and the use of the proceeds from the offering. 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 and 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.
Cision
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SOURCE NRx Pharmaceuticals, Inc.
