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NRXP MOVING UP NOW
$NRXP Positive data and FDA comment would trigger the next $4 million milestone payment from partners Alvogen and Lotus and their assumption of development costs; agreement provides for up to $329 million in milestone payments and a royalty on Net Sales in the mid-teens
$NRXP PR Newswire: NRx Pharmaceuticals (NASDAQ: NRXP) Announces Last Patient, Last Visit in its Phase 2b/3 Trial of NRX-101 in Suicidal Treatment Resistant Bipolar Depression
Mon, Mar 4, 2024, 8:30 AM EST
In This Article:
NRXP
+1.28%
NRXPW
+2.50%
Marks a major step in the development of what could be the first drug approved for Suicidal Bipolar Depression
The study database is being cleaned and locked; statistical analysis and top-line data to follow shortly thereafter
Study maintained 95% concordance rate between study sites and central raters on primary endpoint. No unexpected Serious Adverse Events were reported.
Positive data and FDA comment would trigger the next $4 million milestone payment from partners Alvogen and Lotus and their assumption of development costs; agreement provides for up to $329 million in milestone payments and a royalty on Net Sales in the mid-teens
RADNOR, Pa., March 4, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced that the 74th and last evaluable patient has completed their day 42 visit in its Phase 2b/3 study of NRX-101, the Company's patented combination of the NMDA antagonist D-cycloserine and lurasidone, in Suicidal Treatment Resistant Bipolar Depression. The database is being cleaned, finalized, and locked; statistical analysis will then be performed, with top-line data to follow shortly thereafter. As previously disclosed, positive data from this trial triggers a milestone payment from Alvogen. Alvogen will then be responsible for further development and commercialization costs for this program.
NRX-101 has been 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. It is the only oral medication to have demonstrated reduced suicidal ideation in patients with bipolar depression, a lethal disease that claims the lives of one in five who live with it.
"This is the first clinical trial, to the company's knowledge, conducted among patients with suicidal bipolar depression in the outpatient setting. Our previous trial measured the ability of NRX-101 to maintain the anti-depressant and anti-suicidal effect of ketamine administered in the hospital setting. These patients, whose clinical need is urgent and extraordinary have routinely been excluded from the clinical trials of all previously-known anti-depressant drugs. said Dr. Jonathan Javitt, Founder, Chairman and Chief Scientist of NRx Pharmaceuticals. Although there were patients whose depression worsened and required hospitalization (we don't yet know whether they were on NRX-101 or comparator), patient safety was maintained, and no trial participant suffered a serious unexpected adverse outcome. Our thanks go out to our investigators, clinics, partners and, most importantly, our amazing patients and their families for seeing this study through to this important milestone," "
The Phase 2b/3 trial (www.clinicaltrials.gov NCT 03395392) is a randomized, prospective, multicenter, double-blind study comparing NRX-101 to lurasidone over six weeks. The Principal Investigator is Prof. Andrew Nierenberg of Harvard Massachusetts General Hospital. The primary efficacy endpoint is reduction in depression as measured on the MADRS scale and the secondary endpoint is reduction of suicidal ideation as measured by the Clinical Global Impression Suicidality Scale (CGI-SS). As previously disclosed, treatment compliance and concordance of local raters to central raters scores was in excess of 94%, well above the industry standard that is normally seen in CNS trials.
Top-line results are expected around the end of this quarter.
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. https://finance.yahoo.com/news/nrx-pharmaceuticals-nasdaq-nrxp-announces-133000763.html?soc_src=social-sh&soc_trk=tw&tsrc=twtr via @YahooFinance
$NRXP big news just out: NRx Pharmaceuticals (Nasdaq:NRXP) Launches HOPE Therapeutics, Inc. at the BIO CEO & Investor Conference 2024 https://finance.yahoo.com/news/nrx-pharmaceuticals-nasdaq-nrxp-launches-133000517.html?soc_src=social-sh&soc_trk=tw&tsrc=twtr via @YahooFinance
$NRXP NEWS: NRx Pharmaceuticals (Nasdaq:NRXP) Launches HOPE Therapeutics, Inc. at the BIO CEO & Investor Conference 2024
PR Newswire
Mon, Feb 26, 2024, 8:30 AM EST
In This Article: NRXP
Presentation available on NRx Pharmaceuticals website at https://www.nrxpharma.com/hope-therapeutics/
KEY UPDATES ARE AS FOLLOWS:
NRx management is proposing to award 50% of founding shares in HOPE Therapeutics to current shareholders together with a royalty coupon with an expected ex-dividend date in the near future, all subject to board approval
Dividend to be available to all shareholders who sign a covenant not to engage in short sales of NRx stock, subject to board approval
HOPE anticipates having manufactured ketamine supplies for shipment under 503a pharmacy regulations by July 1, 2024
RADNOR, Pa., Feb. 26, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals," the "Company"), a clinical-stage biopharmaceutical company, today announced that Dr. Jonathan Javitt, Chairman and Chief Scientist of NRx Pharmaceuticals, will present a corporate overview at the BIO CEO & Investor Conference, which is scheduled to take place February 26-27, 2024, at the Marriott Marquis in New York City. Presenting with him will be Matthew Duffy, the newly-appointed co-CEO of HOPE Therapeutics. The presentation will be available on the NRx Pharmaceuticals website at https://www.nrxpharma.com/hope-therapeutics/.
"Subsequent to our announcement last week, we are in the process of completing a Memorandum of Understanding that may enable us to begin sales of IV ketamine to qualified clinics in partnership with a holder of a nationwide pharmacy license. Additionally, we will be updating investors with regard to our plans to add a digital therapeutic component to our ketamine offering that has potential to extend the clinical benefit to patients." said Dr. Javitt. "We thank our investors for their support and look forward to updating the public on our progress towards building a lifesaving therapy."
Presentation Date: Monday, February 26th, 2024
Time: 2:30 PM ET
Location: The Royale Room, Marriot Marquis, New York City
Registration: https://bcic.bio.org/registration
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 wholly-owned subsidiary of 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.
View original content to download multimedia:https://www.prnewswire.com/news-releases/nrx-pharmaceuticals-nasdaqnrxp-launches-hope-therapeutics-inc-at-the-bio-ceo--investor-conference-2024-302070687.html
SOURCE NRx Pharmaceuticals, Inc.
Do I understand correctly that NRXP has until mid-April 2024 to be above $1.00 for 10 days or be de-listed from NASDAQ? It shows up red flagged on my Fidelity ATP account is why I ask. Will this require a reverse split of 4:1? I appreciate thoughts. TIA.
$NRXP SHARE DIVIDEND TO NRXP Shareholders! https://www.prnewswire.com/news-releases/nrx-pharmaceuticals-nasdaqnrxp-to-launch-hope-therapeutics-inc-at-the-bio-ceo--investor-conference-2024-302065827.html
$NRXP HOPE plans to initiate a 506(c) pre-IPO offering of pre-IPO shares for qualified investors that is structured to potentially yield both capital appreciation and a royalty on sales of ketamine https://finance.yahoo.com/news/nrx-pharmaceuticals-nasdaq-nrxp-launch-133000426.html?soc_src=social-sh&soc_trk=tw&tsrc=twtr via @YahooFinance
$NRXP NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) The Company Announces Advance of $5 Million Milestone Payment from Partners Alvogen, Inc. and Lotus Pharmaceutical Co. Ltd. (1975.TW) https://finance.yahoo.com/news/nrx-pharmaceuticals-inc-nasdaq-nrxp-133000063.html?soc_src=social-sh&soc_trk=tw&tsrc=twtr via @YahooFinance
Breaking NEWS! NRXP with planned share dividend to existing NRXP shareholders.
$NRXP Premarket News Out! NRx Pharmaceuticals (Nasdaq:NRXP) to Launch HOPE Therapeutics, Inc. at the BIO CEO & Investor Conference 2024 https://finance.yahoo.com/news/nrx-pharmaceuticals-nasdaq-nrxp-launch-133000426.html?soc_src=social-sh&soc_trk=tw&tsrc=twtr via @YahooFinance
$NRXP News: NRx Pharmaceuticals (Nasdaq:NRXP) to Launch HOPE Therapeutics, Inc. at the BIO CEO & Investor Conference 2024
PR Newswire
Tue, Feb 20, 2024, 8:30 AM EST
In This Article: NRXP
NRXPW +52.04%
HOPE shares currently owned by NRXP with planned share dividend to existing NRXP shareholders
HOPE has now completed initial manufacture of Ketamine for IV infusion and plans to file FDA New Drug Application for treatment of acute suicidality upon demonstration of 2-year shelf stability (expected Q2 2024)
HOPE plans to file patient-level data from two well-controlled clinical trials comparing ketamine to placebo in patients with acute suicidality and depression, which demonstrated a statistically significant benefit (P<.001)
HOPE plans to initiate a 506(c) pre-IPO offering of pre-IPO shares for qualified investors that is structured to potentially yield both capital appreciation and a royalty on sales of ketamine
RADNOR, Pa., Feb. 20, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced that Dr. Jonathan Javitt, Chairman and Chief Scientist of NRx Pharmaceuticals, will present a corporate overview at the BIO CEO & Investor Conference, which is scheduled to take place February 26-27, 2024, at the Marriott Marquis in New York City. Presenting with him will be Matthew Duffy, the newly-appointed co-CEO of HOPE Therapeutics.
Concurrent with the presentation, NRx plans to file a proxy statement, subject to board approval, for Nasdaq:NRXP shareholders outlining the share structure and seeking a shareholder advisory vote to support the planned share dividend for HOPE Therapeutics. The Company has received consistent advice from public shareholders that the planned share dividend and royalty coupon be distributed only to shareholders and warrant-holders who execute a covenant not to participate in short sales of the Company's stock.
"Subsequent to our initial announcement of HOPE Therapeutics in December 2023, we have focused on establishing HOPE's basic corporate and board structure, securing our manufacturing partnerships and manufacturing initial productions batches of ketamine, establishing nationwide distribution, pharmacovigilance, and medical liaison partnerships, and initiating plans to pair ketamine therapy with a novel digital therapeutic that has potential to reinforce the effect of NMDA-targeted drug therapy in reducing suicidal ideation and depression," said Dr. Javitt. "We thank our investors for their support and look forward to updating the public on our progress towards building a lifesaving therapy."
Presentation Date: Monday, February 26th, 2024
Time: 2:30 PM ET
Location: The Royale Room, Marriott Marquis, New York City
Registration: https://bcic.bio.org/registration
SIMULCAST: BIZTV
Information will be available on the NRx website at https://ir.nrxpharma.com/events prior to the conference.
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 wholly-owned subsidiary of 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.
View original content to download multimedia:https://www.prnewswire.com/news-releases/nrx-pharmaceuticals-nasdaqnrxp-to-launch-hope-therapeutics-inc-at-the-bio-ceo--investor-conference-2024-302065827.html
SOURCE NRx Pharmaceuticals
$NRXP - Shareholder meeting planned for February 7, 2024, is cancelled, and will be rescheduled, if necessary; Company expects to convene a new meeting to vote on the HOPE transaction and share dividend, subject to Board approval
https://finance.yahoo.com/news/nrx-pharmaceuticals-inc-nasdaq-nrxp-114800404.html
$NRXP Barchart Technical Opinion rating is a 88% Buy with a Average short term outlook on maintaining the current direction.
https://www.barchart.com/stocks/quotes/NRXP/overview
$NRXP - Company to be initially owned by NRx and current NRx shareholders via a planned tax-free dividend
https://finance.yahoo.com/news/nrx-pharmaceuticals-inc-nasdaq-nrxp-114800404.html
$NRXP "Our Asia Pacific partner, Lotus Pharmaceuticals has identified enrollment completion of the #NRX101 trial in suicidal bipolar depression as a material event in their Q4 filing."
Lotus Reported Unaudited January Revenues of NT$1,996 Million, surging 45.4% MoM.
#bipolar #$NRXP #Nasdaq
Link:
Our Asia Pacific partner, Lotus Pharmaceuticals has identified enrollment completion of the #NRX101 trial in suicidal bipolar depression as a material event in their Q4 filing.
— NRx Pharmaceuticals (@NRxPharma) February 8, 2024
Lotus Reported Unaudited January Revenues of NT$1,996 Million, surging 45.4% MoM. #bipolar #$NRXP
$NRXP Going green! NRx Pharmaceutucals is focused on the high unmet need for lifesaving treatments for people with severe bipolar depression & PTSD in the presence of suicidality.
https://t.co/dQEshQQkQb
NRx Pharmaceutucals is focused on the high unmet need for lifesaving treatments for people with severe bipolar depression & PTSD in the presence of suicidality.
— NRx Pharmaceuticals (@NRxPharma) February 13, 2024
Follow our journey. https://t.co/dQEshQQkQb#mentalhealth #depression #bipolar #PTSD #NRX101 #NRX100 #ketamine $NRXP
The second portion of the milestone will be $4 million and, as before, be triggered by a positive response to the Company's planned end of phase 2 meeting with FDA.
$NRXP
$NRXP NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) Announces Receipt of Positive Nasdaq Listing Determination https://finance.yahoo.com/news/nrx-pharmaceuticals-inc-nasdaq-nrxp-114800600.html @Nasdaq $AAPL $NVDA $MSFT $PATH @NRxPharma #pharma #bipolar #depression
Great point. Those are financial incentives to investing here. $NRXP
$NRXP .50 +4.17% NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) Announces Advance of $5 Million Milestone Payment from Partners Alvogen, Inc. and Lotus Pharma https://finance.yahoo.com/news/nrx-pharmaceuticals-inc-nasdaq-nrxp-133000063.html?soc_src=social-sh&soc_trk=tw&tsrc=twtr via @YahooFinance @Nasdaq $AAPL $NVDA $MSFT $PATH @NRxPharma #pharma #bipolar #depression
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.
"In a market environment where biotech companies have been increasingly challenged to fund clinical development, we appreciate the confidence of partners that share our view that NMDA-antagonist drugs potentially represent a new and potent class of medicines to treat bipolar depression with suicidality. Over the past six months, NRx, Lotus, and Alvogen have formed a close working relationship and we share a joint commitment to bringing this potentially life-saving drug to patients." said Stephen Willard, Chief Executive Officer of NRx Pharmaceuticals.
NRx remains eligible for an additional $324 million in development and sales milestones, as well as tiered double-digit royalties upon approval and commercialization of NRX-101.
$NRXP
Companies continue to work collaboratively to advance NRX-101 through registrational trials
$NRXP - Payment materially extends the Company's cash runway
This is a significant amount of money...
NRx remains eligible for an additional $324 million in development and sales milestones, as well as tiered double-digit royalties upon approval and commercialization of NRX-101.
$NRXP
Awesome News today! Here's the Yahoo Finance link.
$NRXP News February 12, 2024
NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) Announces Advance of $5 Million Milestone Payment from Partners Alvogen, Inc. and Lotus Pharmaceutical Co. Ltd. (1975.TW)
https://finance.yahoo.com/news/nrx-pharmaceuticals-inc-nasdaq-nrxp-133000063.html
She will bust soon.
Impressive news for NRXP today on major funding received for development of the company's breakthrough CNS bio-pharma treatments...
NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) Announces Advance of $5 Million Milestone Payment from Partners Alvogen, Inc. and Lotus Pharmaceutical Co. Ltd. (1975.TW)
Companies continue to work collaboratively to advance NRX-101 through registrational trials
NRx remains eligible for an additional $324 million in development and sales milestones, as well as tiered double-digit royalties upon approval and commercialization of NRX-101.
Payment materially extends the Company's cash runway
RADNOR, Pa., Feb. 12, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced the advance of the first $5 million milestone payment based on the Company's partnership agreement with Alvogen, Inc. and Lotus Pharmaceutical Co. Ltd. (1975.TW).
Under the terms of the updated agreement, the Company will immediately receive $5 million of the first milestone, which NRx will use to fund development of NRX-101 through the phase 2 meeting with FDA. As compensation for advancing the milestone, Alvogen and Lotus will receive 4.1 million warrants to purchase the Company's common stock, at a strike price of $0.40 with a three (3) year term. The second portion of the milestone will be $4 million and, as before, be triggered by a positive response to the Company's planned end of phase 2 meeting with FDA.
NRx then remains eligible to receive up to $320 million in future development and sales milestones, as well as royalty payments escalating to mid-teen percentages on Net Sales, subject to achievement of certain sales volumes. Additionally, Alvogen and Lotus will be responsible for future development and commercialization costs for NRX-101 in treatment of bipolar depression with suicidality.
"In a market environment where biotech companies have been increasingly challenged to fund clinical development, we appreciate the confidence of partners that share our view that NMDA-antagonist drugs potentially represent a new and potent class of medicines to treat bipolar depression with suicidality. Over the past six months, NRx, Lotus, and Alvogen have formed a close working relationship and we share a joint commitment to bringing this potentially life-saving drug to patients." said Stephen Willard, Chief Executive Officer of NRx Pharmaceuticals.
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.
Cautionary Note Regarding Forward-Looking Statements
This announcement of NRx Pharmaceuticals, Inc. includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995, which may include, but are not limited to, statements regarding our financial outlook, product development, business prospects, and market and industry trends and conditions, as well as the Company's strategies, plans, objectives, and goals. These forward-looking statements are based on current beliefs, expectations, estimates, forecasts, and projections of, as well as assumptions made by, and information currently available to, the Company's management.
The Company assumes no obligation to revise any forward-looking statement, whether as a result of new information, future events or otherwise. Accordingly, you should not place reliance on any forward-looking statement, and all forward-looking statements are herein qualified by reference to the cautionary statements set forth above.
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SOURCE NRx Pharmaceuticals
$NRXP NEWS! NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) Announces Advance of $5 Million Milestone Payment from Partners Alvogen, Inc. and Lotus Pharmaceutical Co. Ltd.
Read More - https://ir.nrxpharma.com/2024-02-12-NRx-Pharmaceuticals,-Inc-Nasdaq-NRXP-Announces-Advance-of-5-Million-Milestone-Payment-from-Partners-Alvogen,-Inc-and-Lotus-Pharmaceutical-Co-Ltd-1975-TW
#NRX101 #PharmaNews #suicide #mentalhealth #depression #stress #PTSD #bipolar $NRXP
$NRXP .5011 +8.00% Great corporate update today!
NRx Pharmaceuticals, Inc. (Nasdaq: $NRXP) Reports Comments by Strategic Partner Lotus Pharmaceutical Co. Ltd. (https://t.co/PKVQC2OL7V) in Recent Financial Report.
— NRx Pharmaceuticals (@NRxPharma) February 9, 2024
Read More - https://t.co/ml7RyYSE0F#bipolar #depression #suicide #mentalhealth #NRX101
NEWS: NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) Reports Comments by Strategic Partner Lotus Pharmaceutical Co. Ltd. (1975.TW) in Recent Financial Report
Fri, February 9, 2024 at 8:30 AM EST
In this article: NRXP
+14.20%
Companies continue to work collaboratively to advance NRX-101 in bipolar depression with suicidality
*Lotus notes that NRx has "achieved a significant milestone by completing enrollment for its phase 2b/3 trial of NRX-101 in suicidal treatment-resistant bipolar depression. The readout for this trial is anticipated in Q2 of this year."
*Productive partnership aims to accelerate NRX-101 to patients in need
*Lotus further reported revenues of NT$1996, a 45% month over month increase.
RADNOR, Pa., Feb. 9, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced that its Asia Pacific strategic partner Lotus Pharmaceutical Co. Ltd (1975.TW) identified enrollment completion of the NRx clinical trial in bipolar depression as a material event in is February 7 financial filing.[1] Lotus provides the Asia Pacific component of NRx's global partnership with Alvogen, Inc.
Lotus reported in the accompanying press release that "Lotus Pharmaceutical's strategic partner, NRX Pharmaceuticals, has achieved a significant milestone by completing enrollment for its phase 2b/3 trial of NRX-101 in suicidal treatment-resistant bipolar depression. The readout for this trial is anticipated in Q2 of this year."
"We at NRx are honored that Lotus has focused its resources on helping us advance NRX-101 for the benefit of patients in the Asia Pacific region. As reported by the World Health Organization, suicidal depression is a significant public health crisis in Pacific rim countries[2], just as it is in the US," said Stephen Willard, Chief Executive Officer of NRx Pharmaceuticals. "We recently held very productive meetings at the JP Morgan conference in San Francisco; we share a mutual commitment to bringing a lifesaving treatment to patients who have been excluded from the clinical trials of all known antidepressants and whose only approved treatment today is electroshock therapy."
NRx anticipates further updates regarding its global partnerships in the coming days.
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.
Cautionary Note Regarding Forward-Looking Statements
This announcement of NRx Pharmaceuticals, Inc. includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995, which may include, but are not limited to, statements regarding our financial outlook, product development, business prospects, and market and industry trends and conditions, as well as the Company's strategies, plans, objectives, and goals. These forward-looking statements are based on current beliefs, expectations, estimates, forecasts, and projections of, as well as assumptions made by, and information currently available to, the Company's management.
The Company assumes no obligation to revise any forward-looking statement, whether as a result of new information, future events or otherwise. Accordingly, you should not place reliance on any forward-looking statement, and all forward-looking statements are herein qualified by reference to the cautionary statements set forth above.
1 Lotus Reported Unaudited January Revenues of NT$1,996 Million, surging 45.4% MoM - Lotus (lotuspharm.com)
2 https://apps.who.int/gho/data/node.main.MHSUICIDEASDR?lang=en
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SOURCE NRx Pharmaceuticals, Inc.
$NRXP .51 +9.91% Premarket as NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) Announces the Incorporation of HOPE Therapeutics, Inc., and Planned Share Dividend/Royalty Coupon https://finance.yahoo.com/news/nrx-pharmaceuticals-inc-nasdaq-nrxp-114800404.html
$NRXP "Our Asia Pacific partner, Lotus Pharmaceuticals has identified enrollment completion of the #NRX101 trial in suicidal bipolar depression as a material event in their Q4 filing."
Lotus Reported Unaudited January Revenues of NT$1,996 Million, surging 45.4% MoM.
#bipolar #$NRXP #Nasdaq
Link:
Our Asia Pacific partner, Lotus Pharmaceuticals has identified enrollment completion of the #NRX101 trial in suicidal bipolar depression as a material event in their Q4 filing.
— NRx Pharmaceuticals (@NRxPharma) February 8, 2024
Lotus Reported Unaudited January Revenues of NT$1,996 Million, surging 45.4% MoM. #bipolar #$NRXP
$NRXP NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) Announces the Incorporation of HOPE Therapeutics, Inc., and Planned Share Dividend/Royalty Coupon https://finance.yahoo.com/news/nrx-pharmaceuticals-inc-nasdaq-nrxp-114800404.html?soc_src=social-sh&soc_trk=tw&tsrc=twtr via @YahooFinance
NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) Announces Completion of Enrollment of its Phase 2b/3 Trial of NRX-101 in Suicidal Treatment Resistant Bipolar Depression
January 22 2024 - 06:48AM
PR Newswire (US)
https://ih.advfn.com/stock-market/NASDAQ/nrx-pharmaceuticals-NRXP/stock-news/93100410/nrx-pharmaceuticals-inc-nasdaq-nrxp-announces-c
PR Newswire
Wed, January 17, 2024 at 3:48 AM PST
RADNOR, Pa., Jan. 17, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx" or the "Company"), a clinical-stage biopharmaceutical company developing therapies for suicidal depression, chronic pain, and PTSD, today announced that on January 16, 2024, the Company was notified by The Nasdaq Stock Market LLC ("Nasdaq") that the Nasdaq Hearings Panel (the "Panel") granted the Company's request for the transfer of its listing to The Nasdaq Capital Market, subject to the Company evidencing compliance with all applicable criteria for continued listing on the Capital Market tier, including the $35 million in market value of listed securities (MVLS) and the $1.00 bid price requirements. The Company believes it has already satisfied the market value of listed securities requirement and is working to evidence compliance with the minimum bid price requirement by April 16, 2024, as required by the Panel's decision. An issuer must evidence compliance with the minimum threshold for at least ten consecutive business days to be deemed by Nasdaq to have complied with the applicable requirement.
"NRx is pleased to share this encouraging news with our shareholders as we continue to meet our drug development milestones as set outlined in our recent communications (NRx Corporate Presentation). This quarter we aim to file our first New Drug Application for NRX-100 (ketamine) for treatment of acute suicidal depression and look forward to announcing top line results from our phase 2b/3 trial of NRX-101 (D-cycloserine/lurasidone) in the treatment of suicidal bipolar depression. These milestones, together with additional updates, are anticipated in advance of the Nasdaq compliance date," said Stephen Willard, JD, CEO of NRx.
NRX received the FDA QUIDP for the NRX-101 in Complicated Urinary Tract Infection and Pyelonephritis
From the FDA: III. QIDP DESIGNATION DEFINED
47
48 Section 505E(g) of the FD&C Act provides for the designation by FDA of certain
49 antimicrobial products as QIDPs. A QIDP is defined in section 505E(g) as: "an
50 antibacterial or antifungal drug for human use intended to treat serious or life-threatening
51 infections, including those caused by –
52
53 (1) an antibacterial or antifungal resistant pathogen, including novel or emerging
54 infectious pathogens; or
55
56 (2) qualifying pathogens listed by the Secretary under" section 505E(f) of the
57 FD&C Act.
58
59 The Agency has codified the list of qualifying pathogens at 21 CFR 317.2.
60
61 For a drug product to be designated a QIDP, the sponsor is required to demonstrate that the drug
62 is an "antibacterial or antifungal drug for human use intended to treat serious or life-threatening
infections."3 63 A sponsor requesting a QIDP designation may also include documentation that the
64 product is intended to treat an "antibacterial or antifungal resistant pathogen, including novel or
emerging infectious pathogens"4 65 or a qualifying pathogen as part of the designation request;
66 however, such documentation is not required.
NRx Pharmaceuticals Announces Signing of a Data and Technical Information Agreement with Columbia University Accessing Key Data Demonstrating Efficacy and Safety of Intravenous Ketamine for the Treatment of Suicidal Depression
https://ir.nrxpharma.com/2023-12-19-NRx-Pharmaceuticals-Announces-Signing-of-a-Data-and-Technical-Information-Agreement-with-Columbia-University-Accessing-Key-Data-Demonstrating-Efficacy-and-Safety-of-Intravenous-Ketamine-for-the-Treatment-of-Suicidal-Depression
NRx Pharmaceuticals Announces FDA Clearance of its Investigational New Drug (IND) Application for NRX-101 in the Treatment of Complicated Urinary Tract Infections
https://ir.nrxpharma.com/2023-12-18-NRx-Pharmaceuticals-Announces-FDA-Clearance-of-its-Investigational-New-Drug-IND-Application-for-NRX-101-in-the-Treatment-of-Complicated-Urinary-Tract-Infections
always good info here.. arqt jumped in thanks to whoever fisrt posted
News Release Issued: November 6, 2023 (6:48am EST)
https://ir.nrxpharma.com/2023-11-06-NRx-Pharmaceuticals-and-Nephron-Pharmaceuticals-Announce-Joint-Agreement-to-Develop-Intravenous-Ketamine-to-Treat-Suicidal-Depression
NRx Pharmaceuticals (NRXP) Enters Development Agreement for the Manufacture of Ketamine to Treat Suicidality and Depression
https://www.google.com/url?rct=j&sa=t&url=https://www.streetinsider.com/Corporate%2BNews/NRx%2BPharmaceuticals%2B%2528NRXP%2529%2BEnters%2BDevelopment%2BAgreement%2Bfor%2Bthe%2BManufacture%2Bof%2BKetamine%2Bto%2BTreat%2BSuicidality%2Band%2BDepression/22335240.html&ct=ga&cd=CAEYACoTMjEzNzQyMTU5MTEzNDcwMTg0NzIaNWMyNTMyOTNiYTRkNjY3Mjpjb206ZW46VVM&usg=AOvVaw24Sh_M_p_xsQry2Kr-cHf1
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NRx Pharmaceuticals Board of Directors has authorized its Chairman, CEO, and management to take all necessary steps to affect the Dividend and Royalty Rights to NRXP Shareholders and applicable...
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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...
Marks a major step in the development of what could be the first drug approved for Suicidal Bipolar Depression The study database is being cleaned and locked; statistical analysis and top-line...
NRx Pharmaceuticals received approximately $1.0 million in cash from an existing investor Shares were sold at $0.38, a 26.7% premium the recent share offering, along with one common 5-year warrant...
In the news release, NRx Pharmaceuticals, Inc. Announces Pricing of $1.5 Million Underwritten Public Offering of Common Stock, issued 27-Feb-2024 by NRx Pharmaceuticals, Inc. over PR Newswire, we...
NRx Pharmaceuticals, Inc. (Nasdaq: NRXP), ("NRx Pharmaceuticals" or the "Company"), a clinical-stage biopharmaceutical company, today announced that it intends to offer to sell shares of its...
Presentation available on NRx Pharmaceuticals website at https://www.nrxpharma.com/hope-therapeutics/ KEY UPDATES ARE AS FOLLOWS: NRx management is proposing to award 50% of founding shares in...
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