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$NRXP News: NRx Pharmaceuticals (NASDAQ:NRXP) to Proceed with Two New Drug Applications in 2024; NRX-101 has Been Returned to the Company for Filing
New Drug Application (NDA) for Accelerated Approval planned for NRX-101 in people with bipolar depression and akathisia in 2024, based on two positive trials 1 2 and Breakthrough Therapy Designation. Potential revenue in 2025
NDA for NRX-100 (IV ketamine) in suicidal depression in advanced preparation for submission in 2024; based on four positive trials 3 4 5 6 and Fast Track Designation. Potential revenue in 2025
Gaining these approvals has the potential to yield more than $150 in revenue per NRXP share in the near term, at current share count
Planning for HOPE Therapeutics share distribution progresses; audit nearing completion – critical step towards a public listing
RADNOR, Pa., June 28, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced that advice from regulatory counsel, which includes former senior officials from the Food and Drug Administration, supports filing two New Drug Applications (NDAs) in 2024: an application for Accelerated Approval for NRX-101 to treat bipolar depression in patients with akathisia and an application for approval of NRX-100 (IV ketamine) for treatment of suicidal depression.
(PRNewsfoto/NRx Pharmaceuticals)
(PRNewsfoto/NRx Pharmaceuticals)
While efficacy and safety data are now in hand, filing of the above applications is dependent upon completion of 12-month stability data in manufactured lots as required by FDA regulations.
As disclosed in an 8K filing, NRx will be filing the NRX-101 application without a commercial partner. The addressable market for the accelerated approval indication is such that a compact and efficient salesforce can be constructed by a small company, such as NRx, and current executives at NRx have previously held primary responsibility for launch of similar-sized pharmaceutical assets.
NRx continues work to enable the distribution of shares in Hope Therapeutics. This distribution is dependent upon completion of a public audit and successful review of an SEC Form 10.
"The NRx team has worked diligently since the end of the COVID pandemic to achieve these milestones for our shareholders and most importantly the patients we have always sought to help," said Dr. Jonathan Javitt, Chairman and Chief Scientist of NRx. "Given the near-term market opportunity represented by an accelerated approval process, NRx anticipates a higher potential return to NRx investors associated with an NRx-led initiative than that which would likely be achieved with a large commercial partner."
NRX-101 for Bipolar Depression
NRX-101 is the Company's patented (Composition of Matter), oral combination of the NMDA antagonist D-cycloserine and lurasidone for bipolar depression. Data from two active control clinical trials vs. the standard of care, lurasidone, have shown comparable antidepressant efficacy with clinically important reductions in suicidality and/or akathisia. To the Company's knowledge, no other oral agent has demonstrated such a valuable profile.
Up to 15% of people treated with drugs in lurasidone's class develop akathisia7; this would constitute an estimated $3.7 billion initial market for NRX-101, with no approved medicines for akathisia. This is a population the Company can readily address without a large commercial partner, given the relatively small number of psychiatrists who treat high-risk patients. The broad bipolar market constitutes 7 million people and an opportunity greater than $20 billion per year. With a best-in-class product profile, the Company projects NRX-101 sales in excess of $2 billion.
NRX-101 was awarded Breakthrough Therapy Designation, Fast Track Designation, a Biomarker Letter of Support, and a Special Protocol Agreement by the FDA for treatment of suicidal bipolar depression.
NRX-100 (IV ketamine) for Suicidal Depression
Intravenous ketamine is widely accepted as a standard of care for acute treatment of suicidal depression, in the absence of an FDA-labeled product; the only treatment currently approved by FDA is electroconvulsive therapy (ECT).
According to the CDC, 3.5 million Americans make a plan for suicide each year.8 This represents a $3-5 billion market at expected pricing.
Based on the data in the trials referenced above, the Company's regulatory counsel has encouraged the Company to file an NDA for suicidal depression for NRX-100. This application has been in development and awaits 12-month stability data for filing, which is expected in 2024.
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-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 NRX-100 (IV ketamine) in the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing 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.
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.
1 Nierenberg A, Lavin P, Javitt DC, et. al. NRX-101 vs lurasidone for the maintenance of initial stabilization after ketamine in patients with severe bipolar depression with acute suicidal ideation and behavior; a randomized prospective phase 2 trial. Int J Bipolar Dis 2023;11:28-38, STABIL-B
2 Nierenberg, et. al., A Randomized, Double-Blind Controlled Comparison of NRX-101 (D-cycloserine/lurasidone) to Lurasidone for Adults with Bipolar Depression and Subacute Suicidal Ideation or Behavior. Am Soc Clin Psych Annual Meeting 2024. ASCP Poster
3 Fava, M et. al., Double-blind, placebo-controlled, dose-ranging trial of intravenous ketamine as adjunctive therapy in treatment-resistant depression (TRD) Mol Psychiatry. 2020; 25(7): 1592–1603.
4 Grunebaum, et. al., Ketamine for Rapid Reduction of Suicidal Thoughts. Am J Psychiatry. 2018 Apr 1: 175(4): 327-335
5 Abbar, et. al. Ketamine for Acute Treatment of Severe Suicidal Ideation, BMJ 2022; 376
6 Anand, et. al, Ketamine is non-inferior to ECT for non-psychotic treatment resistant depression. NEJM 2023 388(25):2315-2325
7 Chow, C, et. Al., Akathisia and Newer Second-Generation Antipsychotic Drugs: A Review of Current Evidence
Pharmacotherapy 2020;40(6):565–574
8 CDC Suicide Data.
HOPE Therapeutics, Inc. (PRNewsfoto/NRx Pharmaceuticals, Inc.)
HOPE Therapeutics, Inc. (PRNewsfoto/NRx Pharmaceuticals, Inc.)
CisionCision
Cision
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SOURCE NRx Pharmaceuticals, Inc.
$NRXP $2.70 +1.12% 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
$NRXP Retweeted: "Heat health awareness is vitally important for individuals living with a mental health condition and their loved ones."
Learn about the impacts and ways to reduce risks: https://bit.ly/4cuvjeO
Heat health awareness is vitally important for individuals living with a mental health condition and their loved ones.
— NAMI (@NAMICommunicate) June 20, 2024
Learn about the impacts and ways to reduce risks: https://t.co/DAzX0cde5r pic.twitter.com/4zbGZ4glWq
$NRXP Another great article on #FactoidFriday #mentalillness #mentalhealthawarenessmonth #mentalhealthmatters #bipolar #NRX101 #NRX100 $NRXP
Learn More - https://nrxpharma.com/nrx-100-nrx-101/#NRX100-101
$NRXP NRxPharma (Nasdaq) holds the only known commercial IND for NRX-100 (IV Ketamine) to treat suicidal depression and is developing NRX-101 (D-Cycloserine & Lurasidone), the first daily, oral treatment for Treatment-Resistant, Suicidal Bipolar Depression
https://compasslivemedia.com/nrxp/
$NRXP news: NRx Pharmaceuticals, a clinical stage pharmaceutical company, today announced that management will participate in the H.C. Wainwright 5th Annual Neuro Perspectives Virtual Conference on June 27, 2024.
Read More - https://ir.nrxpharma.com/2024-06-20-NRx-Pharmaceuticals,-Inc-Nasdaq-NRXP-to-Participate-in-the-H-C-Wainwright-5th-Annual-Neuro-Perspectives-Virtual-Conference-on-June-27,-2024
#PharmaNews #NRX100 #NRX101 $NRXP
NEWS: NRx Pharmaceuticals (NASDAQ:NRXP) Appoints Neuroscience, Information Technology and Medical Technology Veteran to its Board of Directors
PR Newswire
Tue, Jun 18, 2024, 8:30 AM EDT
In this article:NRXP
Dr. Dennis McBride brings extensive experience in Neuroscience and its interface with Information and Medical Technology
Retired at a rank that is the civilian equivalent of a senior flag officer from the United States Navy
RADNOR, Pa., June 18, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced that the Company has added Dr. Dennis McBride to its Board of Directors. Dr. McBride brings deep experience in Neuroscience, Medical and Information Technology and digital therapeutics to the Company.
(PRNewsfoto/NRx Pharmaceuticals)
(PRNewsfoto/NRx Pharmaceuticals)
"I am delighted to welcome Dennis to the Board of NRx. His unique background in both Neuroscience and Medical Technology will be an important asset to the company as we seek to develop more advanced treatments for patients," said Dr. Jonathan Javitt, Chairman and Chief Scientist of NRx. "I have worked with Dennis previously on a highly successful digital therapeutic and know the quality he brings to our company."
"I am proud to join the Board of NRx at such an exciting time for the company – the opportunities have never been greater in Neuroscience to advance and improve novel therapies," commented Dr. McBride. "I look forward to using my experience to help advance its strategy and further the development of NRx's impressive pipeline of CNS products and leading its initiative in digital therapeutics."
Dr. Dennis McBride has led numerous national and international initiatives in neuroscience and its interface with information technology, national security, and medical technology/drug development both within the federal government and in the private sector, three of which are now multi-billion-dollar enterprises. He has formative experience in CNS-focused digital therapeutics, having participated with NRx founders in developing now military-proven digital therapeutic technology for reduction of stress and depression. He was instrumental to the founding of InQTel and other private sector-focused initiatives.
Dr. McBride dedicated his Navy career to Aerospace Medicine and ergonomics, during which he served in leadership roles at six nationally-prominent laboratories, including the Defense Advanced Research Projects Agency (DARPA), Naval Aerospace Medical Research Lab, Naval Research Lab, the Office of Naval Research, and the Naval Medical Research Institute. Upon retiring as a highly decorated Navy Captain, he assumed leadership of the Potomac Institute for Policy Studies, where he continues to serve as President Emeritus. He then joined the National Defense University as a Professor to lead the Center for Technology and National Security Policy, completing his term as a Senior Executive-4 (Civilian equivalent to Vice Admiral). Most recently, he served a tour of duty in the Office of the Secretary of Defense. Dr. McBride has served as an adviser to Cabinet Secretaries, US Congressional Committees, and to corporate C-Suite executives. His educational background includes the University of Georgia, Naval Aerospace Medical Institute, the University of Southern California, the London School of Economics, and Harvard Business School, earning a Ph.D. in experimental psychology and four master's degrees.
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.
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SOURCE NRx Pharmaceuticals, Inc.
$NRXP Innovative Bipolar Depression Treatment by NRx Pharmaceuticals Featured at ASCP June 2024 Meeting -Healthcare Industry Today
https://healthcareindustrytoday.com/article/718753903-innovative-bipolar-depression-treatment-by-nrx-pharmaceuticals-featured-at-ascp-june-2024-meeting-nasdaq-nrxp
#PharmaNews #mentalillness #mentalhealth #depression #ketamine #stress #PTSD #bipolar #NRX100 #NRX101 $NRXP
$NRXP @NRxPharma NRx Pharmaceuticals reposted American Psychiatric Association
@APApsychiatric as the recent tragic death of Professional golfer Grayson Murray put a spotlight on importance on raising mental health awareness https://t.co/yqnKNKETPQ
$NRXP $3.50 +3.55% NRx Pharmaceuticals, Inc. Highlights Breakthrough Oral Antidepressant’s Efficacy in Reducing Suicidality in Bipolar Depression at ASCP June 2024 Meeting - Boston Herald
https://markets.financialcontent.com/bostonherald/article/getnews-2024-6-10-nrx-pharmaceuticals-highlights-breakthrough-oral-antidepressants-efficacy-in-reducing-suicidality-in-bipolar-depression-at-ascp-june-2024-meeting-nrx-pharmaceuticals-inc-nasdaq-nrxp
#PharmaNews #mentalhealth #depression #suicide #PTSD #bipolar #NRX100 #NRX101 $NRXP
$NRXP 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
$NRXP More great news: NRx Pharmaceuticals Showcases First Oral Antidepressant Proven to Reduce Suicidality in Bipolar Depression at ASCP June 2024 Meeting -@APNews
Read More - https://apnews.com/press-release/ein-presswire-newsmatics/pain-management-medication-clinical-trials-d6c73b6690e6e7176e525f0a8c52fbab
#PharmaNews #mentalhealth #depression #ketamine #stress #PTSD #bipolar #NRX100 #NRX101 $NRXP
$NRXP $3.27 +1.87% - NRx Pharmaceuticals reports Q1 results https://seekingalpha.com/news/4106135-nrx-pharmaceuticals-reports-q1-results?source=tweet @NRxPharma
Link to Today's Press Release: https://seekingalpha.com/symbol/NRXP/press-releases
NRx Pharmaceuticals (NASDAQ:NRXP) Publishes Shareholder Update Letter
PR Newswire
Mon, Jun 10, 2024, 8:30 AM EDT
In this article:
NRXP
The June 2024 meeting of the American Society for Clinical Psychopharmacology (ASCP) focused heavily on increasing use of intravenous ketamine and intranasal S-ketamine as the emerging standard of care for treating severe depression and suicidality
Presenters from 3 open label studies at the ASCP suggested that intravenous ketamine is at least equivalent and may have advantages over intranasal S-ketamine
NRx Pharmaceuticals has now reached the 9-month stability point with its ketamine formulation (NRX-100) and has initiated 3 manufacturing lots for future drug release. Nonclinical safety for short term use of NRX-100 has recently been published and submitted to FDA
FDA leadership, in public comments at ASCP, focused on the need for nonclinical safety data for intravenous ketamine as a condition of ketamine approval
The short-term need for intravenous ketamine as an already-approved, schedule 3 drug, is heightened by recent regulatory decisions that may delay the path of potent, schedule 1 psychedelic drugs that may require more complicated clinical trial designs.
RADNOR, Pa., June 10, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced that the Company posted a new Shareholder Update Letter on its website NRx Shareholder Update and further invites interested parties to subscribe to their email alert service to stay up to date on company's progress here: NRx Email Alerts . (Note: not all updates will be included in a Press Release in the future).
Today's update highlights potential implications of the Company's recent activities at the annual meeting of the American Society of Clinical Psychopharmacology. The key points include:
Intravenous and intranasal ketamine were highlighted as emerging standards of care for severe depression and suicidality
Planned NDA filing for NRX-100, our preservative free IV ketamine, for Suicidal Depression in 2024, is based on well controlled trials against both placebo and active comparator. Fast Track Designation was previously granted
An independent FDA advisory panel recently voted against MDMA, a potent, class I psychedelic, refocusing attention on already-approved Schedule 3 drugs such as ketamine for treatment of suicidal depression. The FDA panel and emerging guidance highlights the complexity of clinical trials of DEA Schedule 1 hallucinogens that do not have already-approved human uses
NRx anticipates that an important issue for longer term use of ketamine in depression will be the current multidose vial presentation that contains potentially toxic preservatives previously acceptable for one time use but less suitable for repeated use. NRX-100 is planned as a single-dose, preservative-free medication.
Please subscribe to the Company's email for future updates. NRX Email Alerts Not all of these will be the subject of a Press Release in the future.
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 NRX-100 (IV ketamine), in the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreement. 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.
HOPE Therapeutics, Inc.
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SOURCE NRx Pharmaceuticals, Inc.
$NRXP NEWS: NRx Pharmaceuticals today announced that the Company posted a new Shareholder Update Letter on its website.
Read more - https://ir.nrxpharma.com/2024-06-10-NRx-Pharmaceuticals-NASDAQ-NRXP-Publishes-Shareholder-Update-Letter
#PharmaNews #mentalillness #mentalhealth #mentalhealthmatters #depression #ketamine #stress #PTSD #bipolar #NRX100 #NRX101 $NRXP
$NRXP $3.60 +1.12% @NRxPharma NRx Pharmaceuticals reposted
American Psychiatric Association
@APApsychiatric
Death of golfer Grayson Murray puts spotlight on importance of raising mental health awareness https://t.co/yqnKNKETPQ
$NRXP $3.87 +1.57% -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.
nrxpharma.com/
#ketamine #PTSD #bipolar #NRX100 #NRX101 $NRXP #bullish
$NRXP NRx-101 is the first investigational drug in FDA trials for suicidal bipolar depression, awarded fast track designation, breakthrough therapy designation, and a special protocol agreement by the FDA. @NRxPharma
https://www.nrxpharma.com/ $BMY $JNJ $RENB
$NRXP $3.96 +3.39% NRx Pharmaceuticals (Nasdaq:NRXP) Presents Landmark Trial of NRX-101 in Suicidal Bipolar Depression At the American Society of Clinical Psychopharmacology Annual Meeting
Read More - https://ir.nrxpharma.com/2024-05-28-NRx-Pharmaceuticals-Nasdaq-NRXP-Presents-Landmark-Trial-of-NRX-101-in-Suicidal-Bipolar-Depression-At-the-American-Society-of-Clinical-Psychopharmacology-Annual-Meeting-NRX-101-is-the-First-Oral-Antidepressant-Demonstrated-to-Reduce-Suicidality-
#PharmaNews #mentalhealth #depression #suicide #bipolar #NRX101 $NRXP
$NRXP NEWS: NRx Pharmaceuticals (Nasdaq:NRXP) Presents Landmark Trial of NRX-101 in Suicidal Bipolar Depression At the American Society of Clinical Psychopharmacology Annual Meeting: NRX-101 is the First Oral Antidepressant Demonstrated to Reduce Suicidality in Bipolar Depression
PR Newswire
Tue, May 28, 2024, 8:30 AM EDT
In this article:
Poster presentation of "A Randomized, Double-Blind Controlled Comparison of NRX-101 (D-cycloserine/lurasidone) to Lurasidone for Adults with Bipolar Depression and Subacute Suicidal Ideation or Behavior"
NRX-101 demonstrated a similar antidepressant effect (MADRS reduction ~50%) compared to lurasidone, the Standard of Care drug
NRX-101 demonstrated a 58% relative reduction in time to sustained remission from suicidality (P=.05) compared to lurasidone
NRX-101 demonstrated a 76% reduction in symptoms of akathisia (p=0.03), a side effect linked to suicide, compared to lurasidone
This represents the second trial of NRX-101 demonstrating reduction in suicidality and akathisia associated with NRX-101 compared to lurasidone
RADNOR, Pa., May 28, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", "NRx", the "Company"), a clinical stage pharmaceutical company, today announced presentation of its Phase 2b/3 trial of NRX-101, entitled "A Randomized, Double-Blind Controlled Comparison of NRX-101 (D-cycloserine/lurasidone) to Lurasidone for Adults with Bipolar Depression and Subacute Suicidal Ideation or Behavior" at the American Society of Clinical Psychopharmacology (ASCP) in Miami Beach, FL. The lead author is Prof. Andrew Nierenberg, Director, Dauten Family Center for Bipolar Treatment Innovation, Massachusetts General Hospital and Professor of Psychiatry, Harvard Medical School.
Akathisia rating by study day: a consistent effect is seen commencing at first post-randomization visit and continued throughout the study (Mixed Model for Repeated Measures Regression effect size =0.037, P=0.03)
Akathisia rating by study day: a consistent effect is seen commencing at first post-randomization visit and continued throughout the study (Mixed Model for Repeated Measures Regression effect size =0.037, P=0.03)
"Presentation of these data at this highly respected conference is another important step toward bringing a life-saving product to patients in tremendous need," said Dr. Jonathan Javitt, Chairman and Chief Scientist of NRx. "We believe that NRX-101 may offer a paradigm changing approach to treatment of Bipolar Depression, with a product highly effective in both treating depression and reducing suicidality and associated side effects. We will continue working to bring hope to life with life-saving medications."
The presentation will be held at 11:15 AM, Wednesday May 29, 2024.
W89 A Randomized, Double-Blind Controlled Comparison of NRX-101 (D-cycloserine/lurasidone) to Lurasidone for Adults with Bipolar Depression and Subacute Suicidal Ideation or Behavior
CONCLUSIONS of the Poster are:
NRX-101 and lurasidone both demonstrated > 50% response for treating bipolar depression with no difference seen on primary efficacy endpoint (MADRS)
A clinically meaningful difference was observed on both primary and secondary safety endpoints favoring NRX-101
NRX-101 was associated with 58% relative reduction in time to sustained remission from suicidality as measured by the Columbia Suicide Severity Rating Scale (C-SSRS) when stratified by sex, mood stabilizer use, antipsychotic use, lifetime suicide event (P=0.05).
NRX-101 was associated with a relative 76% reduction in symptoms of akathisia compared to lurasidone that was sustained over 42 days (Effect Size 0.37; P=0.03) on the Barnes Akathisia Rating Scale
Akathisia was seen in 2% of participants treated with NRX-101 vs. 11% treated with lurasidone.
NRX-101 showed superiority to lurasidone in akathisia starting at day 7 and continuing through day 42/ET.
No treatment-related serious adverse event was observed in either group. No safety issues were detected except for MedDRA General disorders: NRX-101 - 18.2% vs lurasidone - 0% (p=0.002).
Based on these findings, together with the earlier STABIL-B trial, the Company believes that NRX-101 has potential to become a standard of care drug for treating bipolar depression, an addressable population of 7 million patients in the US and many times that around the world.
This study represents the second trial conducted under FDA Good Clinical Practices guidelines to demonstrate large and meaningful advantages of NRX-101 vs lurasidone on akathisia and suicidality and clears the path for a registration trial of NRX-101 vs. placebo to treat bipolar depression together with earlier accelerated approval for those with akathisia. An additional academic trial conducted by Chen and co-workers similarly demonstrated a statistically-significant reduction in suicidality associated with D-cycloserine, the active ingredient in NRX-101, compared to various standard of care antidepressants.
To the Company's knowledge, this trial and its prior STABIL-B study represent the only clinical trials in which an oral antidepressant has been demonstrated to cause meaningful reductions in suicidality and akathisia. All currently approved antidepressant drugs carry FDA-mandated "black box" warnings on their labels indicating that they may increase the risk of suicide. Similarly, akathisia – a side effect in which patients are agitated and frequently experience involuntary movement – is a side effect that occurs in 10-15% of patients who take the lurasidone class of drugs and is closely linked to suicide. As shown in the clinical trial, those randomized to lurasidone experienced a substantial increase in akathisia from baseline, whereas those randomized to NRX-101 demonstrated a statistically-significant reduction in akathisia (see Figure).
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.
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.
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SOURCE NRx Pharmaceuticals, Inc.
NRx Pharmaceuticals (Nasdaq:NRXP) Presents Landmark Trial of NRX-101 in Suicidal Bipolar Depression At the American Society of Clinical Psychopharmacology Annual Meeting: NRX-101 is the First Oral Antidepressant Demonstrated to Reduce Suicidality in Bipolar Depression
Poster presentation of "A Randomized, Double-Blind Controlled Comparison of NRX-101 (D-cycloserine/lurasidone) to Lurasidone for Adults with Bipolar Depression and Subacute Suicidal Ideation or Behavior"
NRX-101 demonstrated a similar antidepressant effect (MADRS reduction ~50%) compared to lurasidone, the Standard of Care drug
NRX-101 demonstrated a 58% relative reduction in time to sustained remission from suicidality (P=.05) compared to lurasidone
NRX-101 demonstrated a 76% reduction in symptoms of akathisia (p=0.03), a side effect linked to suicide, compared to lurasidone
This represents the second trial of NRX-101 demonstrating reduction in suicidality and akathisia associated with NRX-101 compared to lurasidone
RADNOR, Pa., May 28, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", "NRx", the "Company"), a clinical stage pharmaceutical company, today announced presentation of its Phase 2b/3 trial of NRX-101, entitled "A Randomized, Double-Blind Controlled Comparison of NRX-101 (D-cycloserine/lurasidone) to Lurasidone for Adults with Bipolar Depression and Subacute Suicidal Ideation or Behavior" at the American Society of Clinical Psychopharmacology (ASCP) in Miami Beach, FL. The lead author is Prof. Andrew Nierenberg, Director, Dauten Family Center for Bipolar Treatment Innovation, Massachusetts General Hospital and Professor of Psychiatry, Harvard Medical School.
"Presentation of these data at this highly respected conference is another important step toward bringing a life-saving product to patients in tremendous need," said Dr. Jonathan Javitt, Chairman and Chief Scientist of NRx. "We believe that NRX-101 may offer a paradigm changing approach to treatment of Bipolar Depression, with a product highly effective in both treating depression and reducing suicidality and associated side effects. We will continue working to bring hope to life with life-saving medications."
The presentation will be held at 11:15 AM, Wednesday May 29, 2024.
W89 A Randomized, Double-Blind Controlled Comparison of NRX-101 (D-cycloserine/lurasidone) to Lurasidone for Adults with Bipolar Depression and Subacute Suicidal Ideation or Behavior
CONCLUSIONS of the Poster are:
NRX-101 and lurasidone both demonstrated > 50% response for treating bipolar depression with no difference seen on primary efficacy endpoint (MADRS)
A clinically meaningful difference was observed on both primary and secondary safety endpoints favoring NRX-101NRX-101 was associated with 58% relative reduction in time to sustained remission from suicidality as measured by the Columbia Suicide Severity Rating Scale (C-SSRS) when stratified by sex, mood stabilizer use, antipsychotic use, lifetime suicide event (P=0.05).NRX-101 was associated with a relative 76% reduction in symptoms of akathisia compared to lurasidone that was sustained over 42 days (Effect Size 0.37; P=0.03) on the Barnes Akathisia Rating Scale
Akathisia was seen in 2% of participants treated with NRX-101 vs. 11% treated with lurasidone.
NRX-101 showed superiority to lurasidone in akathisia starting at day 7 and continuing through day 42/ET.
No treatment-related serious adverse event was observed in either group. No safety issues were detected except for MedDRA General disorders: NRX-101 - 18.2% vs lurasidone - 0% (p=0.002).
Based on these findings, together with the earlier STABIL-B trial, the Company believes that NRX-101 has potential to become a standard of care drug for treating bipolar depression, an addressable population of 7 million patients in the US and many times that around the world.
This study represents the second trial conducted under FDA Good Clinical Practices guidelines to demonstrate large and meaningful advantages of NRX-101 vs lurasidone on akathisia and suicidality and clears the path for a registration trial of NRX-101 vs. placebo to treat bipolar depression together with earlier accelerated approval for those with akathisia. An additional academic trial conducted by Chen and co-workers similarly demonstrated a statistically-significant reduction in suicidality associated with D-cycloserine, the active ingredient in NRX-101, compared to various standard of care antidepressants.
To the Company's knowledge, this trial and its prior STABIL-B study represent the only clinical trials in which an oral antidepressant has been demonstrated to cause meaningful reductions in suicidality and akathisia. All currently approved antidepressant drugs carry FDA-mandated "black box" warnings on their labels indicating that they may increase the risk of suicide. Similarly, akathisia – a side effect in which patients are agitated and frequently experience involuntary movement – is a side effect that occurs in 10-15% of patients who take the lurasidone class of drugs and is closely linked to suicide. As shown in the clinical trial, those randomized to lurasidone experienced a substantial increase in akathisia from baseline, whereas those randomized to NRX-101 demonstrated a statistically-significant reduction in akathisia (see Figure).
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.
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.
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SOURCE NRx Pharmaceuticals, Inc.
$NRXP Oral Antidepressants for Reduction in Suicidality Could Deliver New Standard of Care for Bipolar Depression: NASDAQ NRXP https://www.einpresswire.com/article/707706109/oral-antidepressants-for-reduction-in-suicidality-could-deliver-new-standard-of-care-for-bipolar-depression-nasdaq-nrxp via @ein_news
$NRXP The Big Biz Show interviews Jonathan C. Javitt, M.D., M.P.H./Chief Scientist, Director, and Founder, NRx Pharmaceuticals - https://nrxpharma.com/the-big-biz-show-interviews-jonathan-c-javitt-m-d-m-p-h-chief-scientist-director-and-founder-nrx-pharmaceuticals-4/
#PharmaNews #mentalillness #mentalhealth #mentalhealthmatters #depression #ketamine #stress #PTSD #bipolar #NRX100 #NRX101 $NRXP
$NRXP Top Health Tips your psychiatrist wants you to know. @NRxPharma #May #MentalHealthRecovery
Psychiatrists share their top advice that can help patients improve their mental health and well-being. #MentalHealthMonth https://t.co/DoGDIea5JU
— AMA (@AmerMedicalAssn) May 22, 2024
$NRXP Re-posted this Today! Please share this to all your friends, families and co-workers and Follow
@NRxpharma for more updates. You don't know who needs help or just someone to talk to and May is an important month for #MentalHealthAwareness https://x.com/hominc/status/1790774139864686894/photo/1
$NRXP $4.45 +9.61% NRx Pharmaceuticals (NRXP: Nasdaq) 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 https://www.nrxpharma.com/
$NRXP $3.895 +10.03% #Nasdaq #cancer #FDA
May is #MentalHealthAwarenessMonth. We are 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
May is #MentalHealthAwarenessMonth. We are 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 20, 2024
Follow our journey.https://t.co/dQEshQQSFJ#ketamine #PTSD #bipolar #NRX100 #NRX101 $NRXP
$NRXP $.367 +4.26% HOD $3.71 continues the drive to address the most critical mental health issues. #Nasdaq
#FactoidFriday #mentalhealth #mentalhealthawareness #mentalillness #mentalhealthawarenessmonth #mentalhealthmatters #bipolar #NRX101 #NRX100 $NRXP
— NRx Pharmaceuticals (@NRxPharma) May 17, 2024
Learn More - https://t.co/MyJ7l4ACOc pic.twitter.com/T6LiGyer28
$NRXP $3.96 +22.60% #Bullish Daily Chart! Huge Move Today!
$NRXP The Big Biz Show interviews Jonathan C. Javitt, M.D., M.P.H./Chief Scientist, Director, and Founder of @NRxPharma
$NRXP $3.21 +1.09% HOD $3.25 - NRXP 2024 Catalysts: Positive Clinical Data, Two Planned NDAs, Company Launch of Hope Therapeutics; FDA QIDP award in cUTI and New Schizophrenia Opportunity https://www.nasdaq.com/press-release/nrx-pharmaceuticals-nasdaq:nrxp-reports-first-quarter-2024-financial-results-and
NEWS: NRx Pharmaceuticals (Nasdaq: $NRXP) Reports First Quarter 2024 Financial Results & Provides Business Update
2024 Catalysts: Positive Clinical Data, Two Planned NDAs, Company Launch of Hope Therapeutics; FDA QIDP award in cUTI and New Schizophrenia Opportunity
-Executed Term Sheet from an institutional investor for an initial $7.5 million note, subject to common closing requirements, primarily to replace current debt, clearing the path to a Hope Therapeutics share distribution, with provision for funding up to $30 million to fund pipeline opportunities
-Positive data from a Phase 2b/3 trial of NRX-101 in Treatment Resistant Bipolar Depression (TRBD); trial demonstrated depression efficacy comparable to standard of care and significant reduction of akathisia (P=0.025). Akathisia is a potentially lethal side effect of all serotonin-targeted antidepressants and is associated with suicide. The study additionally demonstrated a 30% advantage in sustained remission from suicidality that was not statistically-significant at this sample size
-Above findings of reduced suicidality mirror the results of the Company's prior STABIL-B trial in acutely suicidal patients and also mirror the results of an independent published trial
-Company plans to file a New Drug Application (NDA) for Accelerated Approval under Breakthrough Therapy and Priority Review of NRX-101 in treatment of bipolar depression in people at risk of akathisia, based on the Phase 2b/3 and STABIL-B data
Company has developed patentable pH neutral formulation for ketamine that will be suitable for both intravenous and subcutaneous administration. Ketamine efficacy data are in hand from 4 clinical trials. Three manufacturing lots are now initiated (required for NDA) and Company plans to initiate the NDA by July
-HOPE Therapeutics (which focuses on care delivery, not drug development) has partnered with representatives of ketamine clinic providers nationwide to construct a care platform that will include ketamine, operational support, and digital therapeutic extensions. In advance of FDA approval, HOPE is actively in the sales process to supply ketamine under 503b pharmacy licensure to meet the national ketamine shortage declared by FDA. HOPE is planned to be spun out as a separate company to be owned by NRx, current NRx shareholders, and new investors; Term Sheets received from prospective anchor investors for $60 million of new investment, once publicly listed
Data expected shortly in 200-person DOD-funded trial of D-cycloserine (DCS), the key component of NRX-101, to treat chronic pain, conducted by Northwestern University. Statistical analysis plan and data unlock have been approved by Northwestern IRB
NRX-101 in the treatment of Complicated Urinary Tract Infection (cUTI) granted Qualified Infectious Disease Product (QIDP), Fast Track, and Priority Review designations. Company has now demonstrated that NRX-101 does not damage the microbiome of the gut, in contrast to all other advanced antibiotics and is less likely to cause C. Difficile infection (a potentially lethal side effect of antibiotic treatment). NRx is reviewing partnership options
-Executed Memorandum of Understanding with Fondation FundaMental for rights to develop potential disease modifying drug for Schizophrenia. If successful, this would represent the first drug to reverse the underlying disease mechanism of schizophrenia, rather than simply treating symptoms.
-Management to host a conference call, May 14, 2024, at 4:30 PM ET
RADNOR, Pa., May 14, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced its financial results for the quarter ended March 31, 2024, and provided a business update.
$NRXP $3.24 +8.36% NRxPharma Eyes First Commercial Revenue in 2024, Announces Breakthroughs in Bi-Annual Milestone Update https://finance.yahoo.com/news/nrx-pharmaceuticals-eyes-first-commercial-135500896.html?soc_src=social-sh&soc_trk=tw&tsrc=twtr
@YahooFinance
$NRXP Attending the EF Hutton Annual Global Conference this Wednesday at The Plaza Hotel in NYC! Read More - https://ir.nrxpharma.com/2024-05-08-NRx-Pharmaceuticals,-Inc-NASDAQ-NRXP-to-Participate-in-the-EF-Hutton-Annual-Global-Conference-on-May-15,-2024
A reminder that NRx Pharmaceuticals will participate in the EF Hutton Annual Global Conference, taking place this Wednesday, May 15, 2024, at The Plaza Hotel in New York City.
— NRx Pharmaceuticals (@NRxPharma) May 13, 2024
Read More - https://t.co/LfEtS29gsl#PharmaNews #ketamine #PTSD #bipolar #NRX100 #NRX101 $NRXP
$NRXP @NRxPharma Unveils Innovative Advances in Bi-Annual Progress Report: (Nasdaq: NRXP) https://www.kxan.com/business/press-releases/ein-presswire/709692023/nrx-pharmaceuticals-eyes-first-commercial-revenue-in-2024-announces-breakthroughs-in-bi-annual-milestones-nasdaq-nrxp/
$NRXP -NRx Pharmaceuticals Sets Sights on Debut Commercial Revenue in 2024, Unveils Innovative Advances in Bi-Annual Progress Report: (Nasdaq: NRXP) https://www.kxan.com/business/press-releases/ein-presswire/709692023/nrx-pharmaceuticals-eyes-first-commercial-revenue-in-2024-announces-breakthroughs-in-bi-annual-milestones-nasdaq-nrxp/
$NRXP $2.81 HOD $2.87 NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Initiates Strategy to Combat Short Sales https://prn.to/4baoVcG $RENB $BMY
$NRXP Huge article out today. NRx Pharmaceuticals Eyes First Commercial Revenue in 2024, Announces Breakthroughs in Bi-Annual Milestone Update https://finance.yahoo.com/news/nrx-pharmaceuticals-eyes-first-commercial-135500896.html?soc_src=social-sh&soc_trk=tw&tsrc=twtr via @YahooFinance
Very good to see NRXP is making every effort to get the word out on the company's important new developments, especially for suicide prevention treatments. This is a top mental health crisis today. The EF Hutton Conference is a great opportunity to reach high value investors and institutions.
The EF Hutton Annual Global Conference, which will take place on May 15, 2024, at The Plaza Hotel in New York City.
NEWS: NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) to Participate in the EF Hutton Annual Global Conference on May 15, 2024
PR Newswire
Wed, May 8, 2024, 8:30 AM EDT
In This Article: NRXP
RADNOR, Pa., May 8, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced that it will participate in the EF Hutton Annual Global Conference, which will take place on May 15, 2024, at The Plaza Hotel in New York City.
Prof. Jonathan Javitt, MD, MPH, the Company's Chairman and Chief Scientist, and Matthew Duffy, the Company's Chief Business Officer, will hold one-on-one meetings with investors throughout the day. Interested parties can register to attend here.
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.
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SOURCE NRx Pharmaceuticals, Inc.
$NRXP More DD: Of the thousands of drugs approved by FDA, only 544 have been designated as “Breakthrough Therapy.” NRX-101 is the first Breakthrough Therapy for Suicidal Depression https://axecapitalusa.com/nrxp/
Be sure to follow NRXP on Twitter (X): Results Show Superior Safety & Efficacy for NRX-101; Accelerated FDA Approval sought for Bipolar Depression
Results Show Superior Safety & Efficacy for NRX-101; Accelerated FDA Approval sought for Bipolar Depression
— NRx Pharmaceuticals (@NRxPharma) May 7, 2024
Read More - https://t.co/VzEAskHG4j#PharmaNews #mentalillness #mentalhealth #mentalhealthmatters #depression #ketamine #stress #PTSD #bipolar #NRX101 $NRXP
NEWS: NRx Pharmaceuticals (Nasdaq:NRXP) Announces Final Clinical Trial Results: Superior Safety Combined with Similar Efficacy in the Trial of NRX-101 Compared to Lurasidone in Suicidal Bipolar Depression
PR Newswire
Mon, May 6, 2024, 8:30 AM EDT
In This Article: NRXP
Both drugs demonstrated > 50% response for treating depression. NRX-101 demonstrated a mean 76% reduction in symptoms of akathisia compared to lurasidone that was sustained over 42 days (Effect Size .37; P=0.025), using prespecified analytic methodology memorialized in FDA Special Protocol Agreement. Levels of akathisia with NRX-101 were essentially zero at day 42
This safety advantage was previously reported in the Company's published STABIL-B trial
Akathisia is identified as a life-threatening side effect of nearly all antidepressants, reported in 10-15% of treated patients and is closely linked to suicide in FDA black box warning
Akathisia was seen in 2% of participants treated with NRX-101 vs. 11% treated with lurasidone
Company plans to seek accelerated approval of NRX-101 for use in patients with bipolar depression at risk of akathisia while continuing to broaden the indication to all patients with bipolar depression and perhaps schizophrenia
Study will be presented at the American Society of Clinical Psychopharmacology (ASCP) meeting May 28-31, 2024 (Miami) together with study investigators, accompanied by a broadcast scientific presentation on akathisia and antidepressant safety, and investor Q&A
RADNOR, Pa., May 6, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical stage pharmaceutical company, today announced a statistically significant safety advantage of NRX-101 compared to the standard of care comparator in its recently completed clinical trial in patients with suicidal bipolar depression. Therefore, the Company believes that demonstration of reduced akathisia in the setting of comparable antidepressant efficacy constitutes a basis for Accelerated FDA Approval of NRX-101. The full clinical trial results will be presented at the upcoming meeting to the American Society of Clinical Psychopharmacology held May 28-31, 2024 in Miami. NRx will gather Key Opinion Leaders to educate the public on the importance and potentially life-saving implication of this finding.
Figure 1: Akathisia rating by study day: A consistent effect is seen commencing at the first post-randomization visit and continued throughout the study (Mixed Model Repeated Measures Regression Effect size =.37; P=0.025).
Figure 1: Akathisia rating by study day: A consistent effect is seen commencing at the first post-randomization visit and continued throughout the study (Mixed Model Repeated Measures Regression Effect size =.37; P=0.025).
Last week, the Company released preliminary top-line data as required by SEC disclosure rules. The Company believes that today's findings based on mixed model regression analysis as specified in the Company's Special Protocol Agreement with the FDA, when combined with the prior STABIL-B trial1, demonstrate a basis for seeking accelerated drug approval of NRX-101 based on improved safety related to akathisia and suicidality in the setting of comparable antidepressant efficacy.
Trial participants had identical mean scores on the Barnes Akathisia Rating Scale (BARS) at baseline with subsequent decrease in the NRX-101 treated group versus an increase in the lurasidone-treated group, yielding a 76% relative mean difference between the groups. The difference was apparent at the first post-randomization visit and continued throughout the trial. (Fig 1) Over the 42 days of observation, an effect size of .37 was identified with a statistically significant P value of 0.025 on the Mixed Model for Repeated Measures (MMRM) methodology agreed to with FDA in the 2018 Special Protocol Agreement. Akathisia as ascertained by a 1 point increase in the BARS was seen in 11% of participants randomized to lurasidone (comparable to previous reports in the literature) and seen in only 2% of those treated with NRX-101, an akathisia level that was previously reported for the placebo arm of the lurasidone registration trial.
Akathisia was a prespecified key safety endpoint of the Company's clinical trial. Hence this finding is not a "post-hoc" observation. As previously noted, this clinical trial of 91 participants with suicidal bipolar depression who were not pre-treated with ketamine demonstrated that NRX-101 and lurasidone were comparable in their antidepressant effect. A 33% but statistically non-significant sustained decrease in suicidality was also seen favoring NRX-101. As noted above, improved antidepressant efficacy is not required to seek drug accelerated drug approval based on a statistically-significant safety benefit.
Based on this safety finding, NRx plans to seek Accelerated Approval of NRX-101 for treatment of bipolar depression in patients at risk for akathisia who are at highest risk of suicide, while continuing to develop evidence to support broader indications both in treatment of depression and schizophrenia. Should these data be confirmed in additional large scale trials, the Company believes that physicians and patients will universally prefer antidepressant and antipsychotic drugs with a reduced akathisia risk. The NRx patent portfolio supports the development of a broad range of combined NMDA/serotonergic drugs for treatment of depression and psychosis.
There is a recent regulatory precedent for the approval of psychiatry drugs that demonstrate comparable efficacy with improved safety. A combination of olanzapine and samidorphan (LYBALVI®) was approved based on comparable effect on schizophrenia symptoms with evidence of less weight gain favoring LYBALVI. Thus, public assertions by journalists and short-sellers that NRx has no path to market based on the finding of comparable efficacy in this trial are utterly baseless and may be designed to mislead investors.
"More than 7 million Americans suffer from bipolar depression with a potential market opportunity in excess of $20 billion. No prior drug to treat bipolar depression has demonstrated superiority on side effects most closely linked to suicide. Patients with bipolar depression have a 50% lifetime risk of a suicidal attempt and a 20% lifetime risk of dying from suicide. On this basis of these superiority findings, previously seen in the STABIL-B trial, we plan to seek Accelerated Approval from FDA for treatment of patients with bipolar depression who are at risk for akathisia, as we and our partners continue to broaden the indication to the treatment of all patients with bipolar depression." said Dr. Jonathan Javitt, NRx's Chairman and Chief Scientist. "Patients and key opinion leaders alike have told us clearly that an antidepressant with comparable antidepressant effect and reduced risk of akathisia and other risk factors for suicidality would be unambiguously preferred in the marketplace."
Background on Akathisia
Akathisia is a known extrapyramidal side effect of all serotonin-targeted antidepressants and antipsychotic drugs. It can be demonstrated in laboratory models, using rodent behavioral data.2 Prof. Daniel Javitt, the inventor of NRX-101 first discovered the ability of NMDA antagonist drugs to reduce akathisia in 2009, which forms the basis of the Company's composition of matter patent portfolio. In his 2012 patent application Javitt stated 3
A major limitation in use of antipsychotic and antidepressant medications is the liability to produce behavioral side effects, especially anxiety, agitation, and akathisia, all of which are associated with generating or exacerbating suicidality in psychotic or depressed patients. These behavioral side effects can be differentiated from symptoms of the illness by consideration of both time course and specific patterns of symptoms.
The side effect is clearly recognized in an FDA-mandated black box warning applied to lurasidone and all medications in its class of drugs, with a specific warning about suicidality as follows:
"The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and non-psychiatric. Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, there is concern that such symptoms may represent precursors to emerging suicidality"4.
In most clinical trials, safety endpoints are not a basis for drug approval, although adverse safety findings may prevent drug approval. Typically, new drugs are compared to placebo in order to prove a difference in efficacy. In this case, the trial was conducted against the standard of care drug, not against placebo and, therefore, safety differences are highly important. Akathisia is a labeled negative side-effect of lurasidone and all similar drugs, and is closely linked to suicidal behavior.56 It is a side effect about which patients must be warned[7] and has figured prominently in class action lawsuits brought against manufacturers of serotonin-targeted antidepressants and antipsychotics. Currently, there is no FDA-approved treatment for akathisia and it is considered a medical emergency by many treating psychiatrists. Akathisia causes extreme anxiety to patients, inability to control motor movement, and impulsive acts, all to often leading to suicide and may be the key driver of the observed increase in suicidal ideation and behavior associated with all serotonin-targeted antidepressants and antipsychotic drugs.
"These studies support our original observation that D-cycloserine reverses the akathisia-like behaviors induced by lurasidone in rodent models. It is exciting to see those findings demonstrated in a second trial with unequivocal statistical significance," said Prof. Daniel Javitt, co-founder of NRx Pharmaceuticals. "Hopefully, this opens a path to bringing a lifesaving drug to millions of patients with suicidal depression whose only approved long-term treatment is electroconvulsive therapy."
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.
1 Nierenberg A, Lavin P, Javitt DC, et. al. NRX-101 vs lurasidone for the maintenance of initial stabilization after ketamine in patients with severe bipolar depression with acute suicidal ideation and behavior; a randomized prospective phase 2 trial. Int J Bipolar Dis 2023;11:28-38, doi.org/10.1186/s40345-023-00308-5
2 Walf, A. A., & Frye, C. A. (2007). The use of the elevated plus maze as an assay of anxiety-related behavior in rodents. Nature Protocols, 2(2), 322-328. https://doi.org/10.1038/nprot.2007.44
3 Javitt DC. Composition and method for treatment of depression and psychosis in humans. US Patent 10583138B2. Granted March 10, 2020.
4 Trivedi et al., J Clin Psychiatry, 72:765-774, 2011
5 Chow LC, Kahouh NK, Bostwick JR, et. al., Akathisia and newer second-generation antipsychotic drugs: A review of current evidence. Pharmacotherapy 202;40(6):565-574 doi: 10.1002/phar.2404
6 Uwai Y, Nabekura T. Risk factors for suicidal behavior/ideation and hostility/aggression in patients with bipolar disorders: An analysis using the Japanese adverse drug event report database. J Psychiatric Res 2022;153:99-103. https://doi.org/10.1016/j.jpsychires.2022.07.005
7 https://www.webmd.com/schizophrenia/side-effects-of-lurasidon
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SOURCE NRx Pharmaceuticals, Inc.
$NRXP $2.27 +8.10% Premarket- New analyst report from Ed Woo, CFA, NRx Pharmaceuticals publishing analyst at Ascendiant Capital Markets. View Report - https://t.co/XDweCNyr8U #PharmaNews #mentalillness #depression #ketamine #stress #PTSD #suicide #bipolar #NRX101 $NRXP #Bullish
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$NRXP $2.28 +11.00% Strong Q4 Results and Milestones Announced Including Approved Stock Dividend & 8 Million More in Capital: (Nasdaq: NRXP) https://www.einpresswire.com/article/700334263/strong-q4-results-and-milestones-announced-including-approved-stock-dividend-8-million-more-in-capital-nasdaq-nrxp via @ein_news
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