NRXP NRX Pharmaceuticals Inc.

3.31
-0.3  -8%
Previous Close 3.61
Open 3.55
52 Week Low 3.4101
52 Week High 26.24
Market Cap $194,662,219
Shares 58,810,338
Float 58,647,319
Enterprise Value $156,293,708
Volume 721,448
Av. Daily Volume 3,471,682
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Drug Pipeline

Drug Stage Notes
BriLife
Covid-19 Variants of Concern Vaccine
Phase 2/3
Phase 2/3
Phase 2/3 trial to begin in 1Q 2022.
Remdesivir and ZYESAMI (Aviptadil) - (ACTIV-3b NIH trial)
COVID-19
Phase 3
Phase 3
Phase 3 trial displayed no new safety concerns after review by an independent data safety monitoring board; study cleared to continue enrollment to target 640 patients, noted December 15, 2021. Breakthrough Therapy Designation application submitted to FDA December 29, 2021. Emergency Use Authorization (EUA) submitted to FDA, noted January 5, 2022.
BriLife
COVID-19 vaccine
Phase 2/3
Phase 2/3
Phase 2b/3 to be commenced in December 2021. Regulatory clearance expected by end of 2021.
BriLife002
COVID-19 Vaccine
Phase 2/3
Phase 2/3
Phase 2b/3 completion of data safety meeting DSMB completed review at low, medium, and high doses, with a formal report expected imminently, noted December 6, 2021.
NRX101
Bipolar Depression and Suicidal Ideation
Phase 2/3
Phase 2/3
Phase 2/3 trial to resume in early 2022.
Intravenous ZYESAMI (Aviptadil)
COVID-19
Phase 2/3
Phase 2/3
Phase 2b/3 trial met primary endpoint - March 29, 2021. FDA declined EUA submission on November 4, 2021. New data showed an improvement in blood oxygen levels August 30, 2021. Phase 2b/3 one year data showed a 3-fold advantage in likelihood of being alive at one year post treatment (60% vs. 20%), noted September 27, 2021. Data from ineligible subjects for the Phase 2b/3 trial recorded a 60-day survival in 81% of those treated with aviptadil, compared to 21% survival among those who received standard of care treatment, noted October 14, 2021.
NRX-101
Bipolar Depression in patients with Acute suicidal ideation
Phase 2/3
Phase 2/3
Phase 2/3 trial ongoing.
NRX-100 (Ketamine Hydrochloride)
Acute Suicidal Ideation and Behavior in Bipolar Depression
Phase 3
Phase 3
Phase 3 trial ongoing.

Latest News

    • ZYESAMI® (aviptadil) is currently in a Phase 3 clinical trial being conducted by the National Institutes of Health (NIH)
    • NRx will continue to provide ZYESAMI to hospitals enrolled in NRx's Expanded Access Protocol under US Food and Drug Administration guidelines
    • NRx is also making ZYESAMI available as an investigational medicine under the Federal Right to Try Act1
    • ZYESAMI is available to patients who have progressed despite treatment with remdesivir and other approved medicines and who are not able to participate in the NIH trial
    • NRx manufacturing program now supports increases in demand under Expanded Access and Federal Right to Try programs

    RADNOR, Pa., Jan. 18, 2022 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals (NASDAQ:NRXP) today announced enhancements…

    • ZYESAMI® (aviptadil) is currently in a Phase 3 clinical trial being conducted by the National Institutes of Health (NIH)
    • NRx will continue to provide ZYESAMI to hospitals enrolled in NRx's Expanded Access Protocol under US Food and Drug Administration guidelines
    • NRx is also making ZYESAMI available as an investigational medicine under the Federal Right to Try Act1
    • ZYESAMI is available to patients who have progressed despite treatment with remdesivir and other approved medicines and who are not able to participate in the NIH trial
    • NRx manufacturing program now supports increases in demand under Expanded Access and Federal Right to Try programs

    RADNOR, Pa., Jan. 18, 2022 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals (NASDAQ:NRXP) today announced enhancements to its Expanded Access and Right to Try programs. The programs enable patients with respiratory failure from COVID-19, who have tried all approved medicines, including remdesivir, and who are not able to participate in a clinical study, to receive ZYESAMI® (aviptadil) upon a physician's prescription.

    This expansion comes as supplies of ZYESAMI have increased through the partnership between NRx and Nephron Pharmaceuticals, which is manufacturing ZYESAMI at commercial scale. The expanded production will also support the ongoing ACTIV-3b trial conducted by the National Institutes of Health (NIH) both in the US and Brazil.

    ZYESAMI is a long-term stable form of vasoactive intestinal peptide, which was previously shown in clinical trials to be associated with a two-fold increased odds of survival at 60 days. The subgroup of patients who were treated with ZYESAMI after remdesivir and other approved therapies demonstrated a 2.8-fold increased odds of recovering from respiratory failure by day 28 (P=.03), which was sustained to day 60, together with a four-fold increased odds of surviving to day 60 (P=.006). Adverse events included principally diarrhea (33% aviptadil vs 1.5% placebo) and hypotension (26% aviptadil vs 22% placebo) of patients. Detailed data on results seen in clinical trials of ZYESAMI® (Aviptadil) may be viewed on the NRx website (https://www.nrxpharma.com/right-to-try/). ZYESAMI remains an investigational medicine that is not approved by the US FDA.

    The NIH is currently studying ZYESAMI as part of its ACTIV-3b (TESICO) trial (https://clinicaltrials.gov/ct2/show/NCT04843761), which has enrolled approximately two-thirds of patients and has not identified unexpected safety concerns.

    Hospitals that enroll in the FDA-supervised Expanded Access Program (EAP) are able to store ZYESAMI on-site and provide it to patients without delay.  

    Patients who are hospitalized at facilities not enrolled in the EAP program may be treated under the Federal Right to Try Act, which does require an application to NRx by a licensed, accredited critical care physician and review by the Company's medical team.  

    "Given the urgency caused by the Omicron surge, we have worked with our manufacturing partner to increase production to a level that supports expanded access to our investigational medicine ZYESAMI, potentially at all US hospitals. We will continue to increase production to meet demand in order to offer one last option to patients who have exhausted all currently approved therapies," said Prof. Jonathan C. Javitt, MD, MPH, CEO and Chairman of NRx Pharmaceuticals.

    About NRx Pharmaceuticals

    NRx Pharmaceuticals (NRx) draws upon more than 300 years of collective, scientific, and drug-development experience to bring improved health to patients. The Company is developing the BriLife™ Covid vaccine, developed by the Israel Institute for Biological Research, under an exclusive license from the Israel Ministry of Defense. NRx is additionally developing ZYESAMI® (aviptadil) for patients with COVID-19, and has been granted Fast Track designation by the US Food and Drug Administration (FDA), and is currently undergoing phase 3 trials funded by the US National Institutes of Health, the Biomedical Advanced Research and Development Authority (BARDA) of the US Department of Health and Human Services, and the Medical Countermeasures program, part of the US Department of Defense. The FDA has additionally granted Breakthrough Therapy Designation, a Special Protocol Agreement, and a Biomarker Letter of Support to NRx for NRX-101, an investigational medicine to treat suicidal bipolar depression. NRX-101 is currently in Phase 3 trials, with readouts expected in 2022.

    NRx is led by executives who have held senior roles at Allergan, J&J, Lilly, Novartis, Pfizer, and the US FDA. NRx is chaired by Prof Jonathan Javitt, MD, MPH, who has held leadership roles in six biotechnology startup companies with public exits and been appointed to advisory roles in four US Presidential Administrations. The NRx board includes Dr. Sherry Glied, former US Assistant Secretary for Health (ASPE), Daniel E. Troy, JD, former Chief Counsel of the US FDA, Chaim Hurvitz, former director of Teva and President of the Teva International Group, and General H.R. McMaster, Ph.D. (US Army, Ret.) the 26th United States National Security Advisor.

     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 US 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.

    CORPORATE CONTACT:

    Jack Hirschfield – Head of Corporate Communications, NRx

    INVESTOR RELATIONS

    Eric Goldstein

    Managing Director – LifeSci Advisors


    1 https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/right-try



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    • Neither NRx nor Jonathan Javitt accused current Relief management or board of a criminal past. The lawsuit identifies FINRA actions against Dr. Sevelraju, prior securities investigation, and civil fines against Dr. John Paul Waymack, and a prior securities fraud conviction, incarceration, and SEC fines against Adam Gottbetter.
    • NRx provided all financial records to Relief on December 6, 2021, yet Relief advised the SEC on December 16, 2021, that it received no records from NRx.
    • NRx looks forward to meeting Relief in mediation on February 22, 2022.

    RADNOR, Pa., Jan. 14, 2022 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, responded to today's press release issued by Relief Therapeutics…

    • Neither NRx nor Jonathan Javitt accused current Relief management or board of a criminal past. The lawsuit identifies FINRA actions against Dr. Sevelraju, prior securities investigation, and civil fines against Dr. John Paul Waymack, and a prior securities fraud conviction, incarceration, and SEC fines against Adam Gottbetter.

    • NRx provided all financial records to Relief on December 6, 2021, yet Relief advised the SEC on December 16, 2021, that it received no records from NRx.
    • NRx looks forward to meeting Relief in mediation on February 22, 2022.

    RADNOR, Pa., Jan. 14, 2022 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, responded to today's press release issued by Relief Therapeutics.

    Allegations of securities violations and criminal behavior

    Relief has accused NRx and its CEO of issuing false and misleading statements about the past actions of Relief's Board and Management. Relief has clearly misread those statements. At no time has NRx accused any member of Relief's board of current or past criminal activity. NRx has documented past history of FINRA disciplinary action against Dr. Raghuram Selvaraju, which may readily be verified on the FINRA Brokercheck website1. At least one of those disciplinary events may be connected to Selvaraju's former association in his role with TYME Technologies with Adam Gottbetter, who was ultimately convicted of securities fraud, incarcerated, fined by the SEC, and banned from the penny stock industry for life.23 Mr. Gottbetter introduced himself to NRx as Relief's head of mergers and acquisitions. The complaint filed by NRx also identifies Relief's Regulatory Consultant, John Paul Waymack, MD, ScD, as having been investigated by the Israel Securities Agency (ISA), settled for civil fines with the ISA, and having pled his fifth amendment rights before the US SEC in connection with Kitov Pharmaceuticals.45 NRx further notes that Peter DeSvastich, who was a founding director of Relief's board, similarly served as Chairman of TYME Technologies and worked with Mr. Gottbetter and Dr. Selvaraju in that capacity.

    Allegations of failure to deliver financial records

    Relief has alleged that NRx failed to deliver promised detailed financial records in time for Relief to attend the mediation on January 5, 2022, to which Relief acknowledges it committed to attend. Relief acknowledged receipt on December 6, 2021, of more than 1000 pages of detailed financial information to support research and development costs associated with the development of ZYESAMI. This information was delivered more than 30 days in advance of the January 5, 2022 mediation date. Yet, inexplicably on December 16, 2021, Relief filed a form 20F with the US SEC in which Relief stated (P. 66) over the signatures of Mr. Weinstein and Dr. Selvaraju that "we note that we have not received invoices from NeuroRx that are anywhere close to the amounts that NeuroRx claims are allegedly due. Relief continues to have no idea of how the amount allegedly owed that is set forth in NRx's SEC filings are calculated."

    The crux of the matter

    Relief persists in issuing false and misleading press releases in order to attempt to obscure several basic truths, as outlined in NRx's complaint before the New York State Supreme Court.

    Rather than fund the development of ZYESAMI (aviptadil) as required by the collaboration agreement, Relief breached and repudiated its obligations under the agreement and resorted to malicious defamation of NRx and its CEO in order to distract from a simple breach of contract matter.

    NRx looks forward to mediating this matter on February 22, 2022.

    About NRx Pharmaceuticals

    NRx Pharmaceuticals (NRx) draws upon more than 300 years of collective, scientific, and drug-development experience to bring improved health to patients. The Company is developing the BriLife™ Covid vaccine, developed by the Israel Institute for Biological Research, under an exclusive license from the Israel Ministry of Defense. NRx is additionally developing ZYESAMI® (aviptadil) for patients with COVID-19, and has been granted Fast Track designation by the US Food and Drug Administration (FDA), and is currently undergoing phase 3 trials funded by the US National Institutes of Health, the Biomedical Advanced Research and Development Authority (BARDA) of the US Department of Health and Human Services, and the Medical Countermeasures program, part of the US Department of Defense. The FDA has additionally granted Breakthrough Therapy Designation, a Special Protocol Agreement, and a Biomarker Letter of Support to NRx for NRX-101, an investigational medicine to treat suicidal bipolar depression. NRX-101 is currently in Phase 3 trials, with readouts expected in 2022.

    NRx is led by executives who have held senior roles at Allergan, J&J, Lilly, Novartis, Pfizer, and the US FDA. NRx is chaired by Prof Jonathan Javitt, MD, MPH, who has held leadership roles in six biotechnology startup companies with public exits and been appointed to advisory roles in four US Presidential Administrations. The NRx board includes Dr. Sherry Glied, former US Assistant Secretary for Health (ASPE), Daniel E. Troy, JD, former Chief Counsel of the US FDA, Chaim Hurvitz, former director of Teva and President of the Teva International Group, and General H.R. McMaster, Ph.D. (US Army, Ret.) the 26th United States National Security Advisor.

    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 US 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.

    CORPORATE CONTACT:

    Whit Clay – Co-CEO, Sloane & Company

     

    INVESTOR RELATIONS:

     

    ______________________________

    1
    RAGHURAM SELVARAJU - Broker at H.C.WAINWRIGHT & CO., LLC (finra.org)

    2 https://www.justice.gov/usao-nj/pr/new-york-securities-lawyer-and-owner-registered-broker-dealer-sentenced-18-months-prison#:~:text=Gottbetter%2C%2046%2C%20of%20New%20York,today%20in%20Newark%20federal%20court

    3 https://www.sec.gov/litigation/admin/2015/34-75266.pdf

    4 https://content.edgar-online.com/ExternalLink/EDGAR/0001213900-20-007156.html?hash=06cb54d27ada7d789196b7ba35c32ca2cccfcfeb0bae64ca9ad33c6ee9a4af9c&dest=F20F2019EX2-21_KITOV_HTM#F20F2019EX2-21_KITOV_HTM

    5 https://www.sec.gov/litigation/litreleases/2018/lr24271-application.pdf



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  1. RADNOR, Pa., Jan. 12, 2022 /PRNewswire/ -- NRx Pharmaceuticals (NASDAQ:NRXP) filed a lawsuit on Monday against Relief Therapeutics ((SIX: RLF, OTCQB:RLFTF, RLFTY)), its former collaboration partner, in New York State Supreme Court. https://iapps.courts.state.ny.us/fbem/DocumentDisplayServlet?documentId=Kq2Z2hThuv/7j5mV5Q4PYw==&system=prod The counterclaim details Relief's breach and repudiation of the collaboration agreement, highlights the false nature of Relief's claims to have worldwide rights to Aviptadil, to have engaged in phase 3 research using Aviptadil, and to having any human grade drug available to treat patients. The lawsuit details a past pattern of collusion by Raghuram Selvaraju and members of Relief's management and associates…

    RADNOR, Pa., Jan. 12, 2022 /PRNewswire/ -- NRx Pharmaceuticals (NASDAQ:NRXP) filed a lawsuit on Monday against Relief Therapeutics ((SIX: RLF, OTCQB:RLFTF, RLFTY)), its former collaboration partner, in New York State Supreme Court. https://iapps.courts.state.ny.us/fbem/DocumentDisplayServlet?documentId=Kq2Z2hThuv/7j5mV5Q4PYw==&system=prod The counterclaim details Relief's breach and repudiation of the collaboration agreement, highlights the false nature of Relief's claims to have worldwide rights to Aviptadil, to have engaged in phase 3 research using Aviptadil, and to having any human grade drug available to treat patients. The lawsuit details a past pattern of collusion by Raghuram Selvaraju and members of Relief's management and associates in matters that have led to criminal investigations, sanctions, fines, and in one case incarceration. NRx seeks $185 million in reliance damages as well further punitive damages associated with the libelous and extortionate behavior.  

    NRx regrets Relief's decision to delay the scheduled December mediation to late February and looks forward to resolving this dispute with Relief as soon as possible. Notwithstanding, NRx advised Relief today that the collaboration agreement is no longer in effect, given Relief's breach and repudiation of the agreement. NRx advised Relief's leadership to cease misrepresenting itself as NRx's collaboration partner in communications such as those offered at this week's H.C Wainwright BioConnect Virtual Healthcare Conference and in recent filings before the US Securities and Exchange Commission. NRx believes that it is the shareholders of Relief and the patients in Europe who need access to this medicine who are the primary victims of Relief's claims to have a drug (which they call RLF-100) to offer patients. From NRx's perspective, the chief priority should be saving lives in the middle of a public health emergency. 

    "Now that our counterclaim is filed, we hope to get back to the business of saving lives. The phase 3 trial sponsored by the National Institutes of Health has enrolled more than two-thirds of its participants and is now starting its international phase. We have just submitted data to the FDA documenting that patients treated with ZYESAMI (Aviptadil) after failing to recover on remdesivir have a 3-fold increased odds of recovery from the ICU, compared to those treated with placebo and a 4-fold increased odds of surviving to day 60," said Prof Jonathan Javitt, MD, MPH, Chairman and CEO of NRx. "Just last weekend, we were involved in airlifting our medication under the Federal Right to Try Act to the bedside of a patient in Washington, D.C. who is turning the corner as we speak. Last week, Dr. Jacobo Elgozy published his first-person experience of a last-minute recovery in a Miami Newspaper. https://miamicourant.com/stories/617928153-op-ed-the-emergency-use-law-should-be-used-for-emergencies-like-now Also last week, we received a report from a small hospital in Texas where 17 of 19 patients treated with our drug under the Right to Try program survived and returned to their families.

    It's this mission on saving lives that keeps us going 24/7 and drives us as a company. We continue to pursue regulatory clearance to distribute ZYESAMI under Right to Try laws. We look forward to restarting enrollment next month for our breakthrough drug, NRX-101, for suicidal bipolar depression, particularly since suicide rates have doubled with the stress of the public health emergency. As we shared earlier this week, we look forward to starting a trial of the BriLife vaccine as a booster injection to prevent some of the variants that have circumvented the mRNA vaccines."

    NRx regrets the necessity of terminating the collaboration agreement and answering our former collaboration partner in court in order to expose the true nature of its management's actions. Relief callously breached its contract obligations by failing to fund the research and clinical trials as obligated. Relief has continued to mislead the public and shareholders by claiming, via Mr. Jack Weinstein's presentation at this week's H.C. Wainwright BioConnect Virtual Healthcare Conference, ownership over NRx's expanded access programs, participation in the NIH clinical trials, and development of commercial scale manufacturing and distribution programs undertaken solely by NRx that Relief refused to fund and in which Relief did not participate.

    The myriad of facts in the counterclaim paint a picture of Relief's management refusing to fulfill its commitments under the collaboration agreement, the  main purpose of which was to develop and trial a potentially lifesaving treatment for Covid-19. This behavior is not only a contractual breach but is shameful.  The counterclaim spells this out in great detail. The unique circumstances of this case underscore why we chose to be represented by a former United States Federal prosecutor and an attorney who has been effective in prosecuting malicious foreign enterprises.

    While we at NRx are confident that we will prevail against our former collaboration partner, we are deeply offended by the baseless and libelous accusation of Relief's management that we somehow harmed patients in Europe by withholding clinical data required for its regulatory submission. The simple fact is that Relief never manufactured a drug to distribute to patients and attacked us in order to obscure that deception. The written record shows that we offered Relief our full cooperation despite its breach of contract and even offered to manufacture ZYESAMI to European standards for Relief, only to be rebuffed and ultimately sued.  Certainly, nobody has benefited from this behavior on the part of our former collaboration partner, least of all patients in Europe and the United Kingdom. 

    NRx has now manufactured ZYESAMI according to the Good Manufacturing Practices required by the European Union and the United Kingdom and has retained regulatory counsel in both jurisdictions to make actual drug product immediately pending regulatory approval.  Dr. Francis Collins, formerly of the National Institutes for Allergy and Infectious Diseases (NIAID) recently identified ZYESAMI as one of the few drugs still under study for the very sickest patients with COVID-19, those in the ICU on ventilators. We have recently reported to the FDA an observed 10-fold increase in odds of survival among patients who remain at risk of death despite treatment with remdesivir and other approved therapies.

    We are similarly horrified that Relief's management attempted to coerce NRx into using Relief's patented formulation of aviptadil in critically-ill patients despite Relief's knowledge that the formulation was ineffective because the peptide aggregates and becomes denatured (much like frying an egg). Even though Relief knew its formulation had failed in clinical trials more than 10 years ago, Dr. Selvaraju demanded that NRx use this formulation in order to maintain the charade that Relief had worldwide patent rights. Relief's complaint that began this litigation alleges that we somehow harmed Relief by refusing to use this ineffective formulation, despite repeated written warnings to both NRx and Relief from Relief's former Chief Medical Officer and the inventor on their patent.

    We are confident that the New York State Supreme Court will mete out the penalty merited by this offensive behavior.  In fact, we believe Relief's conduct is so egregious as to warrant the imposition of punitive damages. Under the law, punitive damages may be awarded when reprehensible and malicious conduct is directed not only at the plaintiff but at the public. NRx intends to donate any punitive damages awarded by the Court to assist COVID survivors, as they are the true victims of Relief's actions.

    About NRx Pharmaceuticals

    NRx Pharmaceuticals (NRx) draws upon more than 300 years of collective, scientific, and drug-development experience to bring improved health to patients. The Company is developing the BriLife® Covid vaccine, developed by the Israel Institute for Biological Research, under an exclusive license from the Israel Ministry of Defense. NRx is additionally developing ZYESAMI® (aviptadil) for patients with COVID-19 and has been granted Fast Track designation by the US Food and Drug Administration (FDA) and is currently undergoing phase 3 trials funded by the US National Institutes of Health, the Biomedical Advanced Research and Development Authority (BARDA) of the US Department of Health and Human Services, and the Medical Countermeasures program, part of the US Department of Defense. The FDA has additionally granted Breakthrough Therapy Designation, a Special Protocol Agreement, and a Biomarker Letter of Support to NRx for NRX-101, an investigational medicine to treat suicidal bipolar depression. NRX-101 is currently in Phase 3 trials, with readouts expected in 2022.

    NRx is led by executives who have held senior roles at Allergan, J&J, Lilly, Novartis, Pfizer, and the US FDA. NRx is chaired by Prof Jonathan Javitt, MD, MPH, who has held leadership roles in six biotechnology startup companies with public exits and been appointed to advisory roles in four US Presidential Administrations. The NRx board includes Dr. Sherry Glied, former US Assistant Secretary for Planning and Evaluation (ASPE), Daniel E. Troy, JD, former Chief Counsel of the US FDA, Chaim Hurvitz, former director of Teva and President of the Teva International Group, and General H.R. McMaster, Ph.D. (US Army, Ret.) the 26th United States National Security Advisor.

    About ZYESAMI® (aviptadil)

    Aviptadil is a synthetic form of Vasoactive Intestinal Polypeptide (VIP) first discovered by the late Prof. Sami Said in 1970, and ZYESAMI® is named in his honor. Although primarily concentrated in the lung, it was first purified from the intestinal tract. VIP binds specifically to the alveolar type II cell (ATII) in the air sac (alveolus) of the lung, where it has been shown have potent anti-inflammatory/anti-cytokine activity in animal models of respiratory distress, acute lung injury, and inflammation. Most importantly, VIP stimulates ATII cells to make the surfactant that must coat the lining of the lungs in order for them to exchange oxygen with the blood.  Loss of surfactant causes respiratory failure and alveolar collapse, which are hallmarks of COVID-19.

    COVID-19-related respiratory failure is caused by selective infection of the ATII cell by the SARS-CoV-2 virus. The ATII cells are vulnerable because of their (ACE2) surface receptors, which serve as the route of entry for the virus. Coronavirus infection of the ATII cell shuts down surfactant production, triggers the formation of inflammatory cytokines, and causes cell death (cytopathy). VIP is shown to upregulate surfactant production, block Coronavirus replication in the ATII cell, block cytokine synthesis, and prevent viral-induced cell death (cytopathy). Other than ZYESAMI®, no currently proposed treatments for COVID-19 specifically target this mechanism of action.

    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 US 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.

    MEDIA CONTACT:

    Whit Clay

    Sloane & Company



    917-601-6012

    INVESTOR RELATIONS CONTACT: 

    LifeSci Advisors

      

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/nrx-pharmaceuticals-files-counterclaim-against-its-former-collaboration-partner-relief-therapeutics-301459961.html

    SOURCE NRx Pharmaceuticals

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    • Trial targeted to begin in the first quarter of 2022
    • NRx is coordinating study with the US Health and Human Services Biomedical Advanced Research and Development Authority and several European Governments
    • Israel Ministry of Health has approved first-in-human trial of intradermal BriLife vaccination with the objective of enhancing immune response
    • NRx continues technology transfer and scale up activities in anticipation of GMP manufacture

    RADNOR, Pa., Jan. 11, 2022 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage, biopharmaceutical company, expanded on the information provided Monday at the H.C. Wainwright BioConnect Virtual Conference regarding the BriLife™ investigational vaccine for COVID-19.

    Last week, NRx met with…

    • Trial targeted to begin in the first quarter of 2022
    • NRx is coordinating study with the US Health and Human Services Biomedical Advanced Research and Development Authority and several European Governments
    • Israel Ministry of Health has approved first-in-human trial of intradermal BriLife vaccination with the objective of enhancing immune response
    • NRx continues technology transfer and scale up activities in anticipation of GMP manufacture

    RADNOR, Pa., Jan. 11, 2022 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage, biopharmaceutical company, expanded on the information provided Monday at the H.C. Wainwright BioConnect Virtual Conference regarding the BriLife™ investigational vaccine for COVID-19.

    Last week, NRx met with experts from the Israel Institute for Biological Research (IIBR) to review data and research related to the ability of the BriLife vaccine to induce neutralizing antibodies against the Omicron variant. Based on the preliminary findings, NRx is currently designing a phase 2b/3 study of the BriLife vaccine as a booster to protect against COVID-19 variants of concern including the Omicron variant. Patients in the study will be fully vaccinated with mRNA vaccines. It is anticipated that the study will begin in the first quarter of 2021 in Israel and will be expanded in coordination with the health ministries of several countries. The IIBR previously published initial serological findings documenting a neutralizing antibody response against the Delta variant that was comparable to the response against the wild-type SARS-CoV-2 virus. (JAFFE-HOFFMAN, 2021)

    "We have seen the deadly impact caused by COVID-19 and its increasing number of variants, and we are eager to determine the immunity-building impact the BriLife vaccine may offer on top of that already conferred by baseline mRNA vaccination," said Prof Jonathan Javitt, MD, MPH, Chairman and CEO of NRx Pharmaceuticals. "We are working closely with the experts at the IIBR to design a study that we hope increases BriLife's accelerated path to regulatory approval."

    NRx was contacted in late December by representatives of the US Department of Health and Human Services and several European Governments with a request to present Omicron findings.

    In further news, the Israel Ministry of Health recently approved a study investigating the NanoPass MicronJet™ intradermal injection system for the BriLife vaccine. The NanoPass system, invented in Israel, uses a patented microneedle system to deliver the vaccine into the skin with minimal discomfort.

    This approach is especially promising for the BriLife vaccine because it binds to angiotensin-converting enzyme 2 (ACE2) receptors, which are present in significantly larger quantities in human skin cells than in muscle cells where traditional vaccines are injected. In addition, early data with other vaccines suggests that intradermal delivery of BriLife may result in a more robust immune response at substantially lower vaccine dosing.

    As these studies are moving towards initiation, NRx continues technology transfer and scale-up activities in anticipation of commercial scale manufacture by Q4 2022.

    About NRx Pharmaceuticals

    NRx Pharmaceuticals (NRx) draws upon more than 300 years of collective, scientific, and drug-development experience to bring improved health to patients. The Company is developing the BriLife™ Covid vaccine, developed by the Israel Institute for Biological Research, under an exclusive license from the Israel Ministry of Defense. NRx is additionally developing ZYESAMI® (aviptadil) for patients with COVID-19, and has been granted Fast Track designation by the US Food and Drug Administration (FDA), and is currently undergoing phase 3 trials funded by the US National Institutes of Health, the Biomedical Advanced Research and Development Authority (BARDA) of the US Department of Health and Human Services, and the Medical Countermeasures program, part of the US Department of Defense. The FDA has additionally granted Breakthrough Therapy Designation, a Special Protocol Agreement, and a Biomarker Letter of Support to NRx for NRX-101, an investigational medicine to treat suicidal bipolar depression. NRX-101 is currently in Phase 3 trials, with readouts expected in 2022.

    NRx is led by executives who have held senior roles at Allergan, J&J, Lilly, Novartis, Pfizer, and the US FDA. NRx is chaired by Prof Jonathan Javitt, MD, MPH, who has held leadership roles in six biotechnology startup companies with public exits and been appointed to advisory roles in four US Presidential Administrations. The NRx board includes Dr. Sherry Glied, former US Assistant Secretary for Health (ASPE), Daniel E. Troy, JD, former Chief Counsel of the US FDA, Chaim Hurvitz, former director of Teva and President of the Teva International Group, and General H.R. McMaster, Ph.D. (US Army, Ret.) the 26th United States National Security Advisor.

    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 US 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.

    CORPORATE CONTACT:

    Jack Hirschfield – Head of Corporate Communications, NRx

    INVESTOR RELATIONS

    Eric Goldstein

    Managing Director – LifeSci Advisors

     



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    • New details of clinical trial for BriLife™ to be discussed during company update presentation at the H.C. Wainwright BioConnect Virtual Conference

    • Company presentation time changed to 9 AM EST on Monday, January 10, 2022

    RADNOR, Pa., Jan. 07, 2022 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage, biopharmaceutical company, today announced its Chairman of the Board and Chief Executive Officer, Prof Jonathan Javitt, MD, MPH, will be presenting updates to the Company's business, including new details regarding late-stage trials of the investigational BriLife™ COVID-19 vaccine at the H.C. Wainwright BioConnect Virtual Conference.

    "As the Omicron variant of the Coronavirus continues to surge, NRx has focused on whether…

    • New details of clinical trial for BriLife™ to be discussed during company update presentation at the H.C. Wainwright BioConnect Virtual Conference



    • Company presentation time changed to 9 AM EST on Monday, January 10, 2022

    RADNOR, Pa., Jan. 07, 2022 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage, biopharmaceutical company, today announced its Chairman of the Board and Chief Executive Officer, Prof Jonathan Javitt, MD, MPH, will be presenting updates to the Company's business, including new details regarding late-stage trials of the investigational BriLife™ COVID-19 vaccine at the H.C. Wainwright BioConnect Virtual Conference.

    "As the Omicron variant of the Coronavirus continues to surge, NRx has focused on whether the BriLife® investigational vaccine is effective against this latest variant of COVID-19. Last month, our early data showed BriLife to be effective against the Delta variant," said Prof Jonathan Javitt, Chairman and CEO of NRx Pharmaceuticals. "Yesterday, NRx leaders met with scientists of the Israel Institute for Biological Research to review data on the effectiveness of the BriLife vaccine against the Omicron variant of the SARS-CoV-2 virus. We will provide preliminary findings and discuss enhancements to the planned clinical trials for the BriLife investigational vaccine at the upcoming HC Wainwright BioConnect Conference."

    Details of the presentation can be found below:

    What: H.C. Wainwright BioConnect Virtual Conference

    Date: Monday, January 10, 2022

    Time: 9:00 AM EST

    Link to Presentation: https://journey.ct.events/view/1464b340-bd79-4a96-ae16-572a470d569b

    Earlier today, NRx issued a press release announcing that the presentation would be available starting at 7:00 AM EST on Monday, January 10, 2022. The time of the presentation has changed and will now be available at 9:00 AM EST on January 10.

    About NRx Pharmaceuticals

    NRx Pharmaceuticals (NRx) draws upon more than 300 years of collective, scientific, and drug-development experience to bring improved health to patients. The Company is developing the BriLife™ Covid vaccine, developed by the Israel Institute for Biological Research, under an exclusive license from the Israel Ministry of Defense. NRx is additionally developing ZYESAMI® (aviptadil) for patients with COVID-19, and has been granted Fast Track designation by the US Food and Drug Administration (FDA), and is currently undergoing phase 3 trials funded by the US National Institutes of Health, the Biomedical Advanced Research and Development Authority (BARDA) of the US Department of Health and Human Services, and the Medical Countermeasures program, part of the US Department of Defense. The FDA has additionally granted Breakthrough Therapy Designation, a Special Protocol Agreement, and a Biomarker Letter of Support to NRx for NRX-101, an investigational medicine to treat suicidal bipolar depression. NRX-101 is currently in Phase 3 trials, with readouts expected in 2022.

    NRx is led by executives who have held senior roles at Allergan, J&J, Lilly, Novartis, Pfizer, and the US FDA. NRx is chaired by Prof Jonathan Javitt, MD, MPH, who has held leadership roles in six biotechnology startup companies with public exits and been appointed to advisory roles in four US Presidential Administrations. The NRx board includes Dr. Sherry Glied, former US Assistant Secretary for Health (ASPE), Daniel E. Troy, JD, former Chief Counsel of the US FDA, Chaim Hurvitz, former director of Teva and President of the Teva International Group, and General H.R. McMaster, Ph.D. (US Army, Ret.) the 26th United States National Security Advisor.

    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 US 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.

    CORPORATE CONTACT:

    Jack Hirschfield – Head of Corporate Communications, NRx

    INVESTOR RELATIONS

    Eric Goldstein

    Managing Director – LifeSci Advisors



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