Aankondiging • May 20
NRx Pharmaceuticals, Inc. Announces Joining of Hervé Perron as Chief Scientist NRx Pharmaceuticals, Inc. announced that Dr. Hervé Perron, PhD, formerly Chief Scientist of Geneuro, SA, has joined as Chief Scientist alongside Prof. Marion Leboyer, MD, PhD, who will lead the anti-HERV-W antibody program. The Company anticipates supporting Geneuro through non-dilutive investment channels. Breakeven Date Change • May 19
Forecast breakeven date pushed back to 2027 The 4 analysts covering NRx Pharmaceuticals previously expected the company to break even in 2026. New consensus forecast suggests losses will reduce by 47% to 2026. The company is expected to make a profit of US$132.1m in 2027. Average annual earnings growth of 54% is required to achieve expected profit on schedule. Breakeven Date Change • May 17 The 5 analysts covering NRx Pharmaceuticals previously expected the company to break even in 2026. New consensus forecast suggests the company will make a profit of US$35.5m in 2026. Earnings growth of 51% is required to achieve expected profit on schedule.
Aankondiging • May 14
NRx Pharmaceuticals, Inc. to Report Q1, 2026 Results on May 18, 2026 NRx Pharmaceuticals, Inc. announced that they will report Q1, 2026 results Pre-Market on May 18, 2026 Aankondiging • May 09
NRx Pharmaceuticals, Inc. Announces FDA Clearance to Proceed with Clinical Trial of NRX-101 in Combination with Robotic-Enabled Transcranial Magnetic Stimulation in Patients with Depression and Suicidality NRx Pharmaceuticals announced receipt of clearance from the US Food and Drug Administration to initiate a clinical trial of NRX-101 (D-cycloserine/lurasidone fixed dose combination) vs. placebo in patients with depression and suicidality who are being treated with either Robotic-assisted Transcranial Magnetic Stimulation (TMS) or sham TMS. The placebo-controlled phase 2/3 trial is identified as “A Randomized, Double-Blind, Three-Arm Study of NRX-101 as Adjunctive Therapy to Active or Sham Transcranial Magnetic Stimulation in Adults with Treatment Resistant Major Depressive Disorder (MIND1). The trial will be conducted by NRx Defense Systems, a subsidiary of NRx Pharmaceuticals. The randomized portion of the clinical trial will enroll 240 participants at a US academic teaching hospital and three planned study sites maintained by HOPE Therapeutics, Inc. An additional group of participants is planned to be enrolled at two United States Military Treatment Facilities. Study sites will be announced following approval by Institutional Review Boards. The Principal Investigator of the MIND1 trial, Prof. Josh Brown, PhD, MD served as the Principal Investigator of predecessor Phase 1 and Phase 2 studies funded by the US Defense Advanced Research Projects Agency. The Company anticipates that the newly-approved trial will be supported through non-dilutive sources, given the implications of a short-term effective and noninvasive treatment for depression on force readiness within the military and first responder organizations. In addition to serving as the Company’s Chief Medical Innovation Officer Dr. Brown serves as an Assistant Professor of Psychiatry and Head of TMS Research at Harvard McClean Hospital. The trial will be led organizationally by the President of NRx Defense Systems, Inc., Dr. Dennis K. McBride (CAPT, Medical Service Corps, Ret., US Navy), Distinguished Research Fellow, National Defense University, and former senior executive in the Office of the Secretary of Defense. Dr. McBride twice served as a Program Manager at the Defense Advanced Research Projects Agency. He has led, to highly successful transition, numerous medically complex projects from a wide range of research and development labs and offices in the US Department of War. Aankondiging • May 07
NRx Pharmaceuticals, Inc. Initiates Commercial Manufacturing Order for Preservative Free Ketamine NRx Pharmaceuticals, Inc. announces initiation of a first commercial manufacturing order of its preservative free ketamine product in anticipation of approval under the Generic Drug User Fee Act in Summer 2026. The order is based on stability observed in more than 3 manufactured registration batches and the Company’s successful third-party audit of the manufacturing facility. The Company expects that the initial manufacturing pace will be sufficient to support initial substantial yearly revenues and notes the ability to rapidly scale manufacturing as demand grows. The Company recently announced the appointment of Mr. Glenn Tyson as its Chief Commercial Officer and is in the process of retaining a full commercial team. The NRx product is the first US-manufactured preservative-free ketamine presentation. Manufacturing is accomplished via a blow-fill-seal process that achieves more than 10-fold higher manufacturing throughput than traditional sterile bottling techniques that rely on glass vials and traditional seals.NRx’s presentation of ketamine differs from existing products in that it does not contain a known toxic preservative, Benzethonium Chloride. This preservative is no longer allowed to be included in new drugs and according to FDA policy cannot even be included in hand cleansers and topical antiseptics. As of April 7, 2026, sterile intravenous ketamine remains listed on the American Society of Health-System Pharmacists (ASHP) national drug shortage database. ASHP reports ongoing supply constraints across multiple manufacturers, including product discontinuations, back orders, and reliance on short-dated inventory for certain ketamine injection presentations, particularly higher-concentration vials commonly used in hospital and outpatient settings. These recurring disruptions have periodically required healthcare providers to adjust sourcing and clinical use, highlighting the need for additional reliable, domestically manufactured ketamine supply. Aankondiging • Apr 24
NRx Pharmaceuticals, Inc. Reports Positive FDA Office of Generic Drugs Feedback on Preservative-Free Ketamine Program NRx Pharmaceuticals, Inc. had announced the receipt of a positive Discipline Review Letter from the FDA Office of Generic Drugs and the completion of a supportive meeting with Generic Drug Leadership. The Discipline Review Letter entitled “Quality” covers the areas of Drug Substance, Drug Product, Manufacturing, and Microbiology. The letter requests only administrative changes and updates to prior stability data, all of which are identified as “Minor.” This positive review letter follows the previously announced favorable bioequivalence determination from the FDA Office of Generic Drugs on March 17, 2026, and represents a separate review discipline within the ANDA process. NRx additionally conducted a meeting with leadership of the FDA Office of Generic Drugs in which the national priority around expediting approval of ketamine, now documented in the President’s April 16, 2026 Executive Order, was recognized by FDA leadership. The Executive Order -- ACCELERATING MEDICAL TREATMENTS FOR SERIOUS MENTAL ILLNESS calls for expedited approval of drugs to treat severe depression and suicidality. The approval of the preservative-free ketamine ANDA is particularly important because of supply shortages documented by physicians who seek to obtain ketamine for use in the clinic setting. FDA leadership expressed support for addressing the remaining aspects of the current ANDA application within the current review cycle that targets approval in Summer 2026. NRx’s presentation of ketamine differs from existing products in that it does not contain a known toxic preservative, Benzethonium Chloride. This preservative is no longer allowed to be included in new drugs and according to FDA policy cannot even be included in hand cleansers and topical antiseptics. Ketamine is identified as medically necessary by the US Department of Veterans Affairs for the treatment of suicidality and treatment-resistant depression. In addition to the current ANDA, NRx is in the process of submitting a New Drug Application to align the labeling of ketamine with its use in treating depression and suicidality. NRX-100 has been awarded Fast Track Designation for the treatment of Suicidal ideation in Depression, including Bipolar Depression. NRX-101 has been awarded Breakthrough Therapy Designation for the treatment of suicidal bipolar depression. NRx has filed an Abbreviated New Drug Application (ANDA), and initiated a New Drug Application filing for NRX-100 for the treatment of suicidal ideation in patients with depression, including bipolar depression. Aankondiging • Apr 21
NRx Pharmaceuticals Announces Fast Track Designation And FDA Guidance For NRX-100 To Treat Depression Including Bipolar Depression NRx Pharmaceuticals has been awarded Fast Track designation and recently received FDA guidance anticipating NRx’s upcoming New Drug Application for NRX-100 (preservative free ketamine) to treat depression, including bipolar depression, in patients who may have suicidal ideation. The order directs the Commissioner of the US Food and Drug Administration to provide Commissioner’s National Priority Vouchers (CNPV) to appropriate psychedelic drugs that have received a Breakthrough Therapy designation and are in accordance with the criteria of the National Priority Voucher Program. NRx has applied for a CNPV in support of its upcoming New Drug Application for NRX-100. The Presidential order further directs the Department of Health and Human Services and FDA to collaborate with the Department of Veterans Affairs and the Private Sector to increase clinical trial participation, data sharing, and real-world evidence generation regarding psychedelic drugs …to facilitate the timely evaluation and approval of drugs that meet standards for approval under section 505 of the Federal Food, Drug, and Cosmetic Act. This aspect of the executive order is expected to facilitate NRx’s proposed use of Real World Evidence and already-completed federally-funded clinical trials in support of drug approval. NRX-100 has been awarded Fast Track Designation for the treatment of Suicidal ideation in Depression, including Bipolar Depression. NRX-101 has been awarded Breakthrough Therapy Designation for the treatment of suicidal bipolar depression. Aankondiging • Apr 14
NRx Pharmaceuticals, Inc. Announces Appointment of Glenn Tyson as Chief Commercial Officer NRx Pharmaceuticals, Inc. announced the appointment of Glenn Tyson as the company’s first Chief Commercial Officer. Mr. Tyson has both clinical experience treating patients with serious mental health disorders and 25 years of successful industry commercial experience in the development and sales of medications in this field. He began his career as a counselor in multiple settings working with children and adults with psychiatric conditions and addiction, before joining the pharmaceutical industry where he has spent 25 years developing expertise in all aspects of commercialization and sales. He served at GSK for 14 years in increasingly senior roles. He then joined Indivior as VP of Strategy and New Product Development, and then SVP of Sales and Marketing and subsequently President of Behavioral Health. He led Indivior in the successful launch of SUBLOCADE®, a once-monthly injectable for the treatment of opioid addiction, delivering 17 consecutive quarters of double-digit growth during his tenure. Most recently, Mr. Tyson has focused on the emerging sector of companies developing neuroplastic therapies for psychiatric conditions, including leadership level work with Transcend Therapeutics who recently announced a $700m deal with Otsuka. As Chief Commercial Officer, Mr. Tyson will be responsible for building world-class market-access, distribution, sales and marketing functions to support commercialization of this NDA, as well as future pipeline assets in psychiatry designed to address the tremendous unmet needs of people suffering with serious mental illnesses. Aankondiging • Apr 07
NRx Pharmaceuticals, Inc. Announces FDA Labeling Alignment For Preservative-Free Ketamine Application NRx Pharmaceuticals, Inc. has received a letter from the Labeling Program of the FDA Office of Generic Drugs whose only comments were limited to minor formatting changes to the proposed label for the Company's preservative-free ketamine product. The Company expects to submit the final label this month. The determination is deemed preliminary until final supervisory review of NRx’s Abbreviated New Drug Application with anticipated approval in Summer 2026. NRx previously received a preliminary determination of bioequivalence for this product. This determination by FDA is meaningful in that NRx’s product has the potential to substantially augment the supply of US manufactured ketamine at a time when multiple suppliers of ketamine are advising the medical community that they are on backorder. NRx’s preservative free product is manufactured in the United States at a time when the FDA has deemed ketamine to be a highly strategic product and recently awarded a Commissioner’s National Priority Voucher for a new US manufacturing source of ketamine drug ingredient. A key administration focus has been the “re-shoring” of critical elements of the US drug supply. In addition to the pending ANDA application for Preservative Free Ketamine, NRx is preparing a New Drug Application under Fast Track Designation to expand the use of intravenous ketamine to treat patients with severe depression, who may have suicidal ideation. NRX-100 (preservative-free intravenous ketamine) has been awarded Fast Track Designation for the treatment of Suicidal ideation in Depression, including Bipolar Depression. NRX-101 has been awarded Breakthrough Therapy Designation for the treatment of suicidal bipolar depression. NRx has filed an Abbreviated New Drug Application (ANDA), and initiated a New Drug Application filing for NRX-100 with an application for the Commissioner’s National Priority Voucher Program for the treatment of suicidal ideation in patients with depression, including bipolar depression. Aankondiging • Mar 20
NRx Pharmaceuticals, Inc. to Report Fiscal Year 2025 Results on Mar 24, 2026 NRx Pharmaceuticals, Inc. announced that they will report fiscal year 2025 results on Mar 24, 2026 Aankondiging • Mar 18
NRx Pharmaceuticals Announces FDA Bioequivalence Determination for Preservative-Free Ketamine Application NRx Pharmaceuticals, Inc. announced that it has received a letter from the Bioequivalence Program of the FDA Office of Generic Drugs stating that “FDA has not identified any bioequivalence deficiencies at this time.” The determination is deemed preliminary until final supervisory review of NRx’s Abbreviated New Drug Application with anticipated approval in Summer 2026. This determination by FDA is meaningful in that the proposed NRx product is the first ketamine formulation to be free of benzethonium chloride (BZT), a known toxic preservative. Benzethonium chloride is not listed by FDA as Generally Recognized as Safe (GRAS) and is no longer permitted in certain topical consumer applications. Ketamine formulations containing BZT date back to an era when the safety profile of quaternary amine preservatives was less well characterized. Prior to NRx’s preservative-free formulation, it was widely believed that BZT was required to maintain room temperature stability and sterility of ketamine. The Company anticipates demonstrating three years of room temperature stability and sterility for its preservative-free product. NRx has filed patents in the US and Internationally to support its preservative-free formulation and has the potential to create a “branded generic” product. NRx’s preservative free product is manufactured in the United States at a time when the FDA has identified ketamine as a strategically important medication and has emphasized the need for resilient domestic supply chains for critical drugs. The FDA recently awarded a Commissioner’s National Priority Voucher to support the establishment of a new U.S. manufacturing source of ketamine drug substance, reflecting broader regulatory and policy focus on re-shoring essential medicines and reducing reliance on foreign supply. In addition to the pending ANDA application for Preservative Free Ketamine, NRx is preparing a New Drug Application under Fast Track Designation to expand the use of intravenous ketamine to treat patients with severe depression, who may have suicidal ideation. Aankondiging • Mar 16
NRx Pharmaceuticals Inc Confirms Path To New Drug Application With Real World Data And Broader Proposed Indication For NRX-100 Ketamine NRx Pharmaceuticals, Inc. had received confirmatory minutes from an in-person Type C guidance meeting at the headquarters of the US Food and Drug Administration. The meeting was attended by leaders of the FDA Division of Psychiatry Products, the FDA Office of Neuroscience, and the FDA Center for Drug Evaluation and Research. The minutes support FDA’s willingness to review NRx’s application for New Drug Approval of NRX-100 (preservative-free ketamine) based on Substantial Evidence of Effectiveness derived from existing adequate and well controlled trials. No additional clinical trials were requested. NRx agreed with FDA to submit existing patient-level data for review. In the trials discussed with FDA, ketamine has demonstrated dramatic superiority to placebo and to active placebo, together with non-inferiority versus electroshock therapy. Moreover, ketamine has demonstrated statistically significant reduction in suicidal ideation. Notably, electroshock therapy, the only currently-approved treatment for suicidal ideation demonstrated a 30% incidence of memory loss, whereas ketamine did not. The FDA minutes additionally confirm FDA’s willingness to review Real World Evidence as confirmatory evidence of efficacy. Preliminary analysis of that Real World Evidence confirms the effectiveness of intravenous ketamine both in reducing depression and suicidal ideation. Based on the meeting minutes, NRx will seek a primary indication to treat depression in patients with severe depression who may have suicidal ideation, in place of the Company’s original plan to treat only those with suicidal ideation. FDA confirmed in the minutes that no additional nonclinical data would be required for review of NRx’s New Drug Application and that no bridging studies would be needed to support NRx’s preservative-free formulation, for which the Company anticipates at least three years of room temperature shelf stability. In addition to the pending New Drug Application for NRX-100 based on treatment of depression, NRx has a pending Abbreviated New Drug Application for the sale of preservative-free ketamine under its current label for use in anesthesia. FDA agreed to receive that application in September 2025 and assigned a Summer 2026 decision date. Aankondiging • Mar 03
Nrx Pharmaceuticals, Inc. Appoints Prof. Joshua C. Brown, Md, Phd, as Chief Medical Innovation Officer NRx Pharmaceuticals, Inc. announced that it has appointed Prof. Joshua C. Brown, MD, PhD, as its Chief Medical Innovation Officer. Prof. Brown is a psychiatrist, neurologist, and neuroscientist who studies the underlying mechanisms of Transcranial Magnetic Stimulation (TMS) and translating these mechanisms into clinical optimization. He is the Medical Director of the McLean Hospital TMS Service, the Director of TMS research, and founding director of the Brain Stimulation Mechanisms Laboratory with more than $20M awarded in federal funding from the National Institute of Mental Health and the Defense Advanced Research Projects Agency. He holds an appointment with Harvard Medical School as Assistant Professor of Psychiatry and serves as the President of the Clinical TMS Society and founding Editor-in-Chief of the Transcranial Magnetic Stimulation journal. Prof. Brown is an early pioneer in understanding the biologic effect of TMS and enhancing that biologic effect with neuroplastic medications, including D-cycloserine (under development by NRx as NRX-101). Additionally, he has been funded by the Defense Advanced Research Projects Agency to develop pathways to deploy TMS as a therapy for treating combat-related depression and PTSD in a manner that can be forward deployable and enhance force preparedness. At NRx, he will collaborate with Dr. Dennis McBride, PhD (CAPT Ret. US Navy, SES4 Ret., National Defense University and Office of the Secretary of Defense), who serves as a Director and Chief Strategy Officer of NRx Pharmaceuticals. He has received over $20M in federal funding and holds a position at Harvard Medical School. Prof. Brown emphasizes the importance of academic-industry partnerships to translate scientific discoveries into real-world treatments, collaborating with McLean Hospital and other global experts. Aankondiging • Feb 18
NRx Pharmaceuticals, Inc. Announces Path to New Drug Application with Real World Data and Broader Proposed Indication for NRX-100 (ketamine) Following Type C FDA Meeting NRx Pharmaceuticals, Inc. announced that it has completed an in-person Type C guidance meeting at the headquarters of the US Food and Drug Administration. The meeting was attended by leaders of the FDA Division of Psychiatry Products, the FDA Office of Neuroscience, and the FDA Center for Drug Evaluation and Research. Based on oral guidance received at the meeting, NRx believes it has a path to filing an application for New Drug Approval of NRX-100 (preservative-free ketamine) based on Substantial Evidence of Effectiveness derived from existing data from adequate and well controlled trials together with confirmatory evidence from more than 65,000 patients identified in the Real World Evidence dataset. NRx will additionally seek a broader indication to serve patients with treatment resistant depression in the context of suicidality, rather than only the subset of patients with suicidality. The Companies will work collaboratively with the FDA in the coming weeks to finalize the statistical analysis protocol for the full 65,000 person Real World Evidence dataset under FDA's newly published guidance. In preliminary comments ahead of meeting, FDA advised NRx that no additional nonclinical data would be required for review of NRX-100's New Drug Application and that no bridging studies would be needed to support NRx's preservative-free formulation compared to the currently-approved preservative-containing formulation of ketamine. Aankondiging • Feb 03
NRx Pharmaceuticals, Inc. Appoints Joseph M. Casper as Chief Operating Officer, Effective January 27, 2026 On January 27, 2026, the Board of Directors of NRx Pharmaceuticals, Inc. appointed Joseph M. Casper, age 75, as the Chief Operating Officer of the Company, effective January 27, 2026. Mr. Casper brings 35 years of experience in the healthcare industry to the Company’s leadership team. Prior to joining the Company, Mr. Casper has held various senior leadership positions. Mr. Casper has served in consulting leadership positions with Deloitte and First Consulting Group, where he advised large organizations and academic medical centers. His professional experience also includes work with major payer and provider organizations, including Kaiser Permanente and Anthem. He also worked extensively with academic medical centers such as the University Medical Center, Cleveland, Ohio. Mr. Casper is the co-inventor of an early medical record aggregation platform that ultimately scaled to serve more than 15 million patients. Between 2016 to 2021, he served on the board of directors of Ingine Inc., a healthcare artificial intelligence company. Since 2019, he has been serving on the board of directors of ThriveWell Tech, a company focused on senior living technologies. Further, since 2021, he has been serving on the board of directors of Touro University, supporting physician and nursing education through its Colleges of Osteopathic Medicine and Health and Human Services. Additionally, since 2022, he has been serving on the board of directors of SureTest, Inc., a company that develops and delivers intelligent test automation solutions for health systems and enterprise software environments. Between March 2023 and August 2025, Mr. Casper served as the Chief Strategy Officer of Ryte AI, artificial intelligence-powered healthcare data analytics platform.
Previously, Mr. Casper served a two-year term as Chairman of the Leukemia Society, Northwest Chapter. His experience spans organizations ranging from early-stage companies to multi-billion-dollar enterprises. Aankondiging • Jan 17
NRx Pharmaceuticals, Inc., Annual General Meeting, Mar 23, 2026 NRx Pharmaceuticals, Inc., Annual General Meeting, Mar 23, 2026. Aankondiging • Jan 14
NRx Pharmaceuticals, Inc. Announces 70,000 Patient Data on Real World Use of Ketamine for Treatment of Suicidal Depression to be Submitted to FDA in Support of NRX-100 Approval NRx Pharmaceuticals, Inc. announced that it has licensed Real World Evidence (RWE) drawn from over 70,000 patients in the United States who were treated with either intravenous ketamine or nasal S-ketamine for depression and suicidal ideation. The information is being submitted in support of NRx's application for Accelerated Approval of NRX-100 (preservative-free ketamine) under Fast Track Designation for Treatment of Suicidal Ideation in Depression and Bipolar Depression. Currently, there is no medicine approved to treat suicidal ideation and the only FDA-approved treatment is Electroshock Therapy. The RWE is provided by Osmind, a leading neuropsychiatry technology and medical records platform used by clinics across the United States. Through this collaboration, Osmind is supplying regulatory-grade real-world evidence (RWE) to the US Food and Drug Administration (FDA) to support NRx's application for Acceleration of NRX-100 (preservative-free ketamine) as a treatment for suicidal ideation in depression, including bipolar depression. Osmind offers an real-world dataset on ketamine and esketamine with a large, diverse patient base and a comprehensive set of fit-for-purpose data variables spanning effectiveness and safety with longitudinal capture. This dataset includes nearly one million treatment sessions with ketamine or esketamine, hundreds of millions of datapoints of continuous vitals monitored during treatment, and differentiated data elements such as assessment of bladder symptoms and sedation. NRx is optimistic that when the full real-world dataset of over 70,000 patients is analyzed, the results will be clinically meaningful. In September 2025, FDA altered its policy to allow the submission of RWE that does not include personally-identifiable patient information, a policy shift that enables the submission of de-identified data from Osmind. Aankondiging • Nov 12
NRx Pharmaceuticals, Inc. to Report Q3, 2025 Results on Nov 17, 2025 NRx Pharmaceuticals, Inc. announced that they will report Q3, 2025 results Pre-Market on Nov 17, 2025 Aankondiging • Sep 30
NRx Pharmaceuticals, Inc. Re- Files Abbreviated New Drug Application (ANDA) for KETAFREE, Preservative-Free IV Ketamine NRx Pharmaceuticals, Inc. announced the re-filing of its Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) for KETAFREE™?, its preservative-free IV ketamine formulation, for use in all existing approved indications. The filing follows FDA grant of approval of its suitability petition for NRx's proposed strength of preservative-free ketamine. The current annual ketamine market is estimated at $750 million, with global demand for ketamine projected to grow to $3.35 billion by 2034. Accordingly, NRx is seeking priority review from FDA. The Company previously filed a citizen's petition with the FDA to remove benzethonium chloride (BZT), a known neurotoxic and cytotoxic substance, from presentations of ketamine intended for intravenous use. The FDA has previously dis allowed the use of BZT in hand cleansers and topical antiseptics. NRx has filed expert testimony from accredited toxicologists regarding the toxicity of BZT, which is not generally recognized as safe (GRAS) by the FDA. BZT was originally added to ketamine when it was first formulated in the 1970s to maintain stability and sterility using the container closure systems then available. The formulation filed under the ANDA is distinct from that used in the New Drug Application (NDA), for which the Company has received Fast Track Designation for Treatment of Suicidal Ideation in Depression, including Bipolar depression. The Company anticipates submitting clinical trial data from more than 1,000 patients and real-world data from more than 180,000 patients in which ketamine demonstrated superiority to placebo and active placebo, with noninferiority to electroconvulsive therapy. Aankondiging • Sep 26
NRx Pharmaceuticals, Inc. Receives Notification of US Food and Drug Administration Approval of Suitability Petition for NRx's Proposed Strength of Preservative-Free Ketamine NRx Pharmaceuticals, Inc. announced that it was notified by the United States Food and Drug Administration that a Suitability petition has been granted for the strength proposed by the Company for its planned single-patient, preservative-free ketamine product (KETAFREE). Currently, ketamine is sold in multi-dose vials that contain Benzethonium Chloride, a toxic preservative. The Suitability petition that has been granted enables immediate re-filing of the Company's Abbreviated New Drug Application for KETAFREE™?. The Company believes that this proposed product addresses two critical policy objectives as articulated by the current administration: (1) the re-shoring of strategically important drugs, particularly sterile products from foreign manufacturing sources, and (2) the "Make America Healthy Again" (MAHA) objective of removing toxic preservatives and colorants from foods and drugs. These objectives have been articulated on numerous occasions by FDA and HHS leadership. The current market for ketamine is estimated at $750 million. The Company believes that its proposed KETAFREE™? product will be a successful offering in that market, wholly apart from the Company's aim to supply a non-generic formulation of ketamine (NRX-100) as an innovative new drug to treat suicidal depression and PTSD under a New Drug Application. Aankondiging • Aug 28
NRx Pharmaceuticals, Inc. Announces Expanded Access Policy for NRX-100 (Preservative-Free Ketamine) NRx Pharmaceuticals, Inc. announced its expanded access policy for NRX-100 (preservative-free ketamine) based on grant of Fast Track designation for NRX-100 in the treatment of suicidal ideation in patients with depression, including bipolar depression. In granting the Fast Track designation, FDA made the determination that NRX-100 has the potential to address an unmet need, based on an assessment of the preliminary data contained in the Fast Track designation request. Accordingly, NRX-100 is available for expanded access to eligible patients. Upon physician request, NRX-100 available to patients when certain conditions, including the following are met: The patient has a serious or life-threatening illness or condition and is either no longer responsive to or not able to tolerate any approved treatment option; The investigational drug is in active clinical development with sufficient data available to determine an appropriate dose and schedule for the patient's specific condition; A benefit-risk analysis, based on both the available clinical data as well as the requesting physician's assessment of the individual patient's condition and history, supports making the investigational drug available; Making the investigational drug available will not negatively impact or delay the conduct of clinical trials or regulatory review or approval of the investigational drug for broader patient access; and Adequate supply of the investigational drug is available. Aankondiging • Aug 18
NRx Pharmaceuticals, Inc. has filed a Follow-on Equity Offering in the amount of $6.533998 million. NRx Pharmaceuticals, Inc. has filed a Follow-on Equity Offering in the amount of $6.533998 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 3,959,999
Price\Range: $1.65
Transaction Features: Registered Direct Offering Aankondiging • Aug 15
NRx Pharmaceuticals, Inc. announced delayed 10-Q filing On 08/14/2025, NRx Pharmaceuticals, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. Aankondiging • Jun 24
NRx Pharmaceuticals, Inc. Announces Filing of Commissioner's National Priority Voucher Application for Intravenous Ketamine (NRX-100) NRx Pharmaceuticals, Inc. announced filing for the newly-announced FDA Commissioner's National Priority Voucher program on behalf of NRX-100, its patent-pending, preservative-free formulation of ketamine for intravenous use. On June 17, 2025, FDA Commissioner Marty Makary, MD, MPH announced a new approval pathway, the Commissioner's National Priority Voucher (CPNV)1, for approval of drugs to enhance the health interests of Americans. Previously, on May 25 he identified psychedelic drugs for treatment of suicidal depression and PTSD as a national priority.2 The new voucher may be redeemed by drug developers to participate in a Commissioner-led program that shortens its review time from approximately 10-12 months to 1-2 months following a sponsor's final drug application submission. The new CNPV process convenes experts from FDA offices for a team-based review rather than using the standard review system of a drug application being sent to numerous FDA offices. The FDA plans, in the first year of the program, to give a limited number of vouchers to companies aligned with U.S. national priorities. In addition to receiving the benefits of this program, the agency may also grant an accelerated approval, if the product for which the voucher is used meets the applicable legal requirements for accelerated approval. The FDA Commissioner will use specific criteria to make the vouchers available to companies that are aligned with the national health priorities of: Addressing a health crisis in the U.S., Delivering more innovative cures for the American people, Addressing unmet public health needs, and Increasing domestic drug manufacturing as a national security issue. To qualify for the CNPV, sponsors must submit the chemistry, manufacturing, controls (CMC) portion of the application and the draft labeling at least 60 days before submitting the final application. NRx has already submitted the CMC portion for NRX-100 and received FDA feedback. The Company believes it meets each of the above criteria. Moreover, NRx has focused on innovative US high throughput manufacturing to replace a ketamine supply chain that frequently relies upon foreign sources and has added anti-diversion features to its product. Suicidal depression and PTSD have been identified by the President of the United States and members of the Cabinet as a health crisis in the US. The FDA has already determined that NRX-100 addresses unmet public health needs through the award Fast Track Designation in combination with NRX-101. NRx Pharmaceuticals is manufacturing NRX-100 in West Columbia, SC. NRx has received only one information request from FDA related to the CMC of NRX-100, in which FDA requested documentation related to the ketamine Active Pharmaceutical Ingredient and final proposed labeling language. NRx has complied with that information request. Concurrent with the CNPV process, the Company is preparing a citizen petition to seek withdrawal of preservative-containing forms of ketamine, based on the toxicity associated with the benzethonium chloride preservative used in the historic formulation. The Company has also filed a patent on its preservative-free manufacturing process. Approval of either the citizen petition, or the patent, would be expected to enable the Company to gain market share in the current $750 million generic ketamine market that is forecast to reach $3-5 billion annually by 2033, in addition to a share of the market already established for ketamine products for treating depression. Aankondiging • Jun 05
NRx Pharmaceuticals, Inc. Files Abbreviated New Drug Application (ANDA) for Preservative-Free IV Ketamine NRx Pharmaceuticals, Inc. announced the transmission of its Abbreviated New Drug Application (ANDA) for electronic filing to the U.S. Food and Drug Administration (FDA) for NRX-100, its preservative-free IV ketamine formulation, for use in all existing approved indications such as anesthesia and pain management. The current annual ketamine market is estimated at $750 million, with global demand for ketamine projected to grow to $3.35 billion by 2034. Ketamine currently faces a severe drug shortage according to the American Society of Hospital Pharmacist with no short-term abatement. Accordingly, NRx is seeking priority review from FDA. The Company anticipates filing a citizen's petition with the FDA to remove benzethonium chloride, a known toxic and cytotoxic substance, from presentations of ketamine intended for intravenous use. Management believes that the preservative-free feature of NRX-100 will be deemed of benefit to patients because of the known toxicity of closely related benzalkonium chloride in current drug products.
Preservatives were originally added to sterile injectable products in an era when a single vial of medication was used to treat multiple patients, a practice no longer allowed in US hospitals. NRx has demonstrated that there is no need for such preservatives to maintain stability and sterility in ketamine presentations intended for single-patient use. Should the citizen's petition be granted, all formulations of ketamine sold in the US could face a regulatory requirement to be preservative free. This filing supplements the New Drug Application currently being completed by the Company to extend the labeled indications of ketamine to include the treatment of suicidal depression. The Company anticipates submitting clinical trials data from more than 1,000 patients and real-world data from more than 180,000 patients in which ketamine demonstrated superiority to placebo and active placebo, with noninferiority to electroconvulsive therapy. Aankondiging • May 12
NRx Pharmaceuticals, Inc. to Report Q1, 2025 Results on May 15, 2025 NRx Pharmaceuticals, Inc. announced that they will report Q1, 2025 results After-Market on May 15, 2025 Aankondiging • May 06
NRx Pharmaceuticals, Inc. Files Patent Application for NRX-100, its Proprietary, Preservative Free Formulation of IV Ketamine NRx Pharmaceuticals, Inc. announced the filing of a patent application for NRX-100, its preservative-free intravenous ketamine formulation for the treatment of suicidal depression. The application discloses pharmaceutical compositions, methods of treatment and methods of manufacture and currently includes twenty claims. While subject to the patent review process of the US Patent and Trademark Office, if granted, the patent would provide NRX-100 exclusivity into 2045. NRX-100 is specifically formulated without benzethonium chloride or other preservatives, which have been associated with cytotoxic or neurotoxic effects. Current governmental leadership has expressed strong interest in delivering medications without unnecessary or unproven preservatives. Demonstration of room temperature shelf stability in the absence of toxic excipients represents a novel pharmaceutical composition that has the potential to be listed in the FDA Orange Book. This patent filing builds on the Company's recently initiated filing of an NDA for NRX-100 and its prior Fast Track Designation, with NRX-101, from the FDA. If granted, the patent will help protect the innovation behind this formulation as NRx advances its commercialization strategy. Aankondiging • May 01
NRx Pharmaceuticals, Inc. Announces FDA Award of Filing Fee Waiver for Upcoming NRX-100 New Drug Application to Treat Patients with Suicidal Depression NRx Pharmaceuticals, Inc. announced the grant of a filing fee waiver by the US Food and Drug Administration ("FDA") to exempt the Company from a $4.3 million fee to file its New Drug Application for NRX-100 (preservative-free ketamine). The waiver is granted at the discretion of the FDA to Small Business Entities and for drugs that are deemed to be necessary for Public Health. The Company anticipates that this waiver enables the completion of its New Drug Application forNRX-100 with currently-available corporate resources. The NDA filing is anticipated by the end of the second quarter of this year (Q2 2025). NRx has now demonstrated stability and sterility sufficient to maintain more than two years of shelf life in a preservative-free presentation. This patent-pending process is anticipated to yield long-term exclusivity should NRX-100 be approved by the FDA. As previously announced, NRx will be submitting data from controlled clinical trials that demonstrate ketamine to be superior to both a placebo and an active comparator, as well as either non-inferior or superior to electro shock therapy in treating various forms of depression, including patients with active suicidal ideation. Although ketamine in various forms is increasingly used to treat depression and related disorders, it is approved by FDA only for use as an anesthetic and, therefore, not reimbursed by most insurance carriers for treatment of suicidality or depression. By applying for FDA approval to treat suicidal depression with NRX-100, the Company hopes to make this potentially life-saving therapy available to all Americans, not just those who are able to pay out of pocket. The Company notes recent statements by the Secretary of Health and Human Services supporting the importance of psychedelic drugs to treat severe depression and PTSD. Aankondiging • Mar 12
NRx Pharmaceuticals, Inc. to Report Q4, 2024 Results on Mar 17, 2025 NRx Pharmaceuticals, Inc. announced that they will report Q4, 2024 results Pre-Market on Mar 17, 2025 Aankondiging • Jan 30
NRx Pharmaceuticals, Inc. announced that it has received $15 million in funding from Streeterville Capital, LLC On January 28, 2025. NRx Pharmaceuticals, Inc has closed the transaction. it has issued $5.435 million in Notes with an aggregate purchase price of approximately $5.0 million. Aankondiging • Jan 29
NRx Pharmaceuticals, Inc. has filed a Follow-on Equity Offering in the amount of $3.500001 million. NRx Pharmaceuticals, Inc. has filed a Follow-on Equity Offering in the amount of $3.500001 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 1,215,278
Price\Range: $2.88
Transaction Features: Registered Direct Offering Aankondiging • Jan 15
NRx Pharmaceuticals, Inc. Announces the Appointment of Michael Taylor to Its Board of Directors NRx Pharmaceuticals, Inc. announced the appointment of Mr. Michael Taylor and Ms. Anita Nunes as Member and Observer of its Board of Directors, respectively. Michael Taylor brings over 25 years of experience in global credit markets, with a focus on special situations and capital formation. He has served as Partner at the Adi Dassler International Family Office in Nassau, Bahamas, and as Managing Director at Oppenheimer & Co., where he specialized in complex debt structuring and multijurisdictional transactions. Prior to that, he spent eight years at Stone & Youngberg as Managing Director of Institutional Fixed Income Trading and Alternative Investments. Michael began his career as a Bond Trader at Morgan Stanley. A graduate of the London School of Economics with a Bachelor of Science in Economics and International Relations, Michael has built a reputation for navigating complex financial environments and delivering innovative solutions. These skills will be integral to the growth of the HOPE clinic network. He joins NRx Pharmaceuticals as the Board Designee of Smith & Sauer, LLC, following the recently announced financing. Anita Nunes, CEO and Co-Founder of Smith & Sauer, LLC, is an accomplished executive with more than 20 years of experience leading transformative growth across industries. She has driven investments in pioneering ventures, including Smith and Sauer's recent $27 million investment in Hope Therapeutics and NRx Pharmaceuticals, where her leadership is advancing mental health care and pharmaceutical innovation. Anita has a strong background in artificial intelligence, where she has led global initiatives to integrate AI-driven solutions, enabling businesses to achieve operational excellence and adapt to dynamic market demands. Her extensive healthcare expertise includes work with industry leaders McKesson and Gilead, where she was instrumental in managing strategic initiatives and fostering innovation. In addition to her work at Smith & Sauer, Anita is the Founder of Mocktail Nation, a health-conscious beverage brand, and Pluzze Consulting, where she has provided strategic guidance to empower entrepreneurs and investors. Her ability to align financial strategies with impactful outcomes has positioned her as a leader in purpose-driven investments, delivering long-term value to stakeholders and society. She has served on multiple Boards of Directors and is recognized for her extensive expertise in healthcare, technology, and pharmaceuticals. Aankondiging • Dec 30
NRx Pharmaceuticals, Inc. Files Initial Section of U.S. New Drug Application to the FDA for NRX-100 (IV Ketamine) for the Treatment of Suicidal Depression NRx Pharmaceuticals, Inc. announced the transmission of first section of its New Drug Application (NDA) for NRX-100 (ketamine) for electronic filing with the U.S. Food & Drug Administration (FDA). NRX-100 was initially granted Fast Track Designation in 2017 for use in combination with NRX-101 (D-cycloserine/lurasidone) for treatment of suicidal bipolar depression. The Company is now seeking to expand the indication to include Suicidal Ideation in Major Depressive Disorder and other forms of depression, based on data from NIH- and European Government-funded trials that have been summarized on the Company's website. While assembly of the clinical data sections is being completed, FDA has asked the Company to submit the 1800-page manufacturing section (Module 3) of the NDA to enable immediate review prior to submission of final efficacy data and other sections of the NDA expected in the first quarter of 2025. The NRx presentation of ketamine differs from the form of ketamine used in anesthesia in that it contains no potentially toxic preservatives and utilizes diversion-resistant packaging to enhance the traceability of a medicine known to have abuse potential. Suicidal depression is considered a national crisis. According to the CDC over 13 million Americans seriously consider suicide each year and 3.8 million make a plan to do so. 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 the FDA is electroconvulsive therapy (ECT). According to the CDC, 3.8 million Americans make a plan for suicide each year. This represents a $3-5 billion market at expected pricing. Based on the data in the trials referenced above, the Company's regulatory counsel encouraged the Company to file an NDA for suicidal depression for NRX-100. Aankondiging • Nov 19
NRx Pharmaceuticals, Inc. Announces Chief Financial Officer Changes NRx Pharmaceuticals, Inc. announced it has appointed Michael Abrams as its permanent Chief Financial Officer. Mr. Abrams succeeds Interim-CFO Richard Narido, who will continue to support the Company's financial function and other projects. Michael Abrams is a senior finance professional with almost three decades of experience as an executive officer, investment banker, director and senior advisor, which includes serving as the Chief Financial Officer of Arch Therapeutics, RiseIT Solutions. and FitLife Brands. Mr. Abrams has deep experience across multiple functional areas including, but not limited to, financial operations, accounting, mergers and acquisitions, financial engineering, capital raising and shareholder communications. He earned his MBA with Honors from the University of Chicago Booth School of Business following his BBA with Honors from the University of Massachusetts at Amherst, where he was named a William F. Field alumni scholar. Aankondiging • Nov 08
NRx Pharmaceuticals, Inc. to Report Q3, 2024 Results on Nov 14, 2024 NRx Pharmaceuticals, Inc. announced that they will report Q3, 2024 results After-Market on Nov 14, 2024 Aankondiging • Oct 12
NRx Pharmaceuticals, Inc. Announces Chief Executive Officer Changes NRx Pharmaceuticals, Inc. announced that Stephen Willard, the Chief Executive Officer provided notice to the Board that he was resigning from the Company, effective immediately, in order to assume the leadership of an early stage biotechnology company. Mr. Willard’s resignation was not a result of any disagreement with the Company on any matter relating to its operations, policies, or practices, or to any issues regarding its accounting policies or practices. Jonathan Javitt, Chairman of the Board of Directors of the Company, was appointed as Interim Chief Executive Officer concurrent with Mr. Willard’s resignation. All terms and conditions of Dr. Javitt’s existing consulting agreement will remain in full force and effect, a copy of which is filed as Exhibit 10.44 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed March 29, 2024. Except as disclosed herein, there is no arrangement or understanding between Dr. Javitt and any other person pursuant to which he was appointed as the Company’s Interim Chief Executive Officer. There are no family relationships between Dr. Javitt and any of the Company’s directors, executive officers or persons nominated or chosen by the Company to become a director or executive officer. Aankondiging • Aug 28
NRx Pharmaceuticals, Inc., Annual General Meeting, Oct 08, 2024 NRx Pharmaceuticals, Inc., Annual General Meeting, Oct 08, 2024. Aankondiging • Aug 23
NRx Pharmaceuticals, Inc. Announces Resignation of Stephen Willard as Chief Executive Officer On August 14, 2024, NRx Pharmaceuticals, Inc. (Company) announced that Stephen Willard, the Company’s Chief Executive Officer, (CEO) has recommended that the company’s shareholders would be best served by a CEO with commercial pharmaceutical experience, particularly drug launch experience, given the Company’s upcoming new drug applications for NRX-100 and NRX-101. As a result, the Company has initiated a search for a new CEO possessing the desired qualifications. Mr. Willard will continue to serve as the Company’s CEO while this search is initiated. Mr. Willard has indicated that his recommendation is not the result of any disagreement regarding any matter relating to the Company’s operations, policies, or practices. Aankondiging • Aug 14
NRx Pharmaceuticals, Inc. to Report Q2, 2024 Results on Aug 14, 2024 NRx Pharmaceuticals, Inc. announced that they will report Q2, 2024 results After-Market on Aug 14, 2024 Aankondiging • Aug 13
NRx Pharmaceuticals Receives Letter from the Listing Qualifications Staff of the Nasdaq Regarding Market Value of Listed Securities On August 6, 2024, NRx Pharmaceuticals, Inc. (the “Company”) received a letter (the “Letter”) from the Listing Qualifications Staff of The Nasdaq Stock Market, LLC (“Nasdaq”) indicating that from June 14, 2024 to August 5, 2024, the Company’s Market Value of Listed Securities (“MVLS”) was below the minimum of $35 million required for continued listing on The Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(b)(2) (the “MVLS Requirement”). The Letter has no immediate effect on the listing of the Company's Common Stock on The Nasdaq Capital Market.? In accordance with Nasdaq Listing Rule 5810(c)(3)(C), the Company has 180 calendar days from the date of the Letter, or through February 3, 2025 (the “Compliance Date”), to regain compliance with respect to the MVLS Requirement. The Letter states that if the Company’s MVLS closed at $35 million or more for a minimum of ten consecutive business days during the compliance period ending on the Compliance Date, the Staff will provide written confirmation of compliance. If the Company does not regain compliance by the Compliance Date, Nasdaq will provide written notice to the Company that its securities are subject to delisting. At that time, the Company may appeal any such delisting determination. However, there can be no assurance that, if the Company receives a delisting notice from the Staff and appeals the delisting determination, such appeal would be successful. The Company intends to actively monitor the Company’s MVLS between now and the Compliance Date and will take all reasonable measures available to the Company to regain compliance with the MVLS Requirement. While the Company is exercising diligent efforts to maintain the listing of its common stock on Nasdaq, there can be no assurance that the Company will be able to regain or maintain compliance with the applicable continued listing standards set in the Nasdaq Listing Rules. Aankondiging • Jul 29
HOPE Therapeutics, Inc. and NRx Pharmaceuticals, Inc. Announce Alignment with FDA on Pediatric Study Plan for NRX-100 (ketamine) NRx Pharmaceuticals, Inc. announced a communication from the US Food and Drug Administration (FDA) providing feedback and alignment on NRx's proposed initial Pediatric Study Plan (iPSP) for NRX-100 (ketamine) in the treatment of suicidal depression. Congress required the submission of an iPSP as a precondition to filing a New Drug Application in the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA). In support of its upcoming NDA filing, NRx will be submitting existing data supporting the safety and efficacy of ketamine to treat suicidal depression in adults. FDA has now documented its recognition that suicide is a serious and growing public health concern in adolescents as well. Based on the guidance received, NRx and HOPE Therapeutics will commit to conducting a clinical trial of NRX-100 in adolescents aged 9-17 with suicidal depression, but will not be required to study the effects of NRX-100 in younger age groups, following initial approval of NRX-100 in adults. Additional neurotoxicity studies will be conducted in juvenile animal subjects to support the safety of intravenous ketamine in this younger population. Aankondiging • Jun 28
NRx Pharmaceuticals, Inc. to Proceed with Two New Drug Applications in 2024 NRx Pharmaceuticals, Inc. 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. 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-101 will be filing the NRX-101 application without a 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. 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. 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. This application has been in development and awaits 12-month stability data for filing, which is expected in 2024. Aankondiging • Jun 18
NRx Pharmaceuticals, Inc. Appoints Dennis McBride to Its Board of Directors NRx Pharmaceuticals, Inc. 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. 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. Aankondiging • May 29
NRx Pharmaceuticals, Inc. 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 NRx Pharmaceuticals, Inc. 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. 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. Aankondiging • May 09
NRx Pharmaceuticals, Inc. to Report Q1, 2024 Results on May 14, 2024 NRx Pharmaceuticals, Inc. announced that they will report Q1, 2024 results at 4:00 PM, US Eastern Standard Time on May 14, 2024 Aankondiging • May 08
NRx Pharmaceuticals, Inc. Announces Final Clinical Trial Results NRx Pharmaceuticals, Inc. 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. 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 0.37 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. Aankondiging • May 01
NRx Pharmaceuticals, Inc. Announces Promising Findings in Phase 2B/3 Clinical Trial of Nrx-101 Vs. Lurasidone for Treatment of Suicidal Bipolar Depression NRx Pharmaceuticals, Inc. that its Breakthrough Therapy designated investigational drug NRX-101 vs lurasidone demonstrated a promising, though not yet statistically significant 33% reduction in suicidality together with a 70% reduction (P=.076) reduction in symptoms of akathisia – a side effect of antidepressants that is closely linked to suicide and considered a medical emergency. Because of the high-risk nature of these patients, a placebo group could not be employed, and NRX-101, a fixed dose combination of D-cycloserine (DCS) and lurasidone, was compared to lurasidone alone (the standard of care). In the Company's previously published STABIL-B trial (STABIL-B), NRX-101 was demonstrated to be superior to lurasidone in reducing both depression and suicidality after ketamine while showing a trend towards reducing akathisia (a side effect involving restlessness and agitation that is considered a warning sign of impending suicide). In this trial, without prior use of ketamine, NRX-101 and lurasidone were comparable in their effect on depression. The trial was a randomized, prospective, double-blind study conducted at multiple sites in the Unites States whose protocol and statistical analysis plan may be viewed on www.clinicaltrials.gov (NCT03395392). In the current study, without prior use of ketamine, NRX-101 and lurasidone exhibited comparable antidepressant effects, each reducing depression (the primary endpoint) on the Montgomery Asberg Depression Rating Scale (MADRS) by about 50% from baseline. Lurasidone is known to reduce symptoms of depression by approximately 4 points in multiple registration trials compared to placebo. Analysis of suicidality using the Columbia Suicide Severity Rating Scale (C-SSRS) demonstrated a sustained 33% advantage in remission from suicidality favoring NRX-101. This difference was not statistically significant at the phase 2 sample size but met the study's original promising zone criteria and, if sustained in a registration trial of 300 or more patients, would be powered to yield a statistically significant result. The reduction in suicidality is comparable to that demonstrated after ketamine, both in the Company's STABIL-B trial and in an independently conducted trial comparing DCS to placebo after ketamine (Chen, et. al.). A meaningful remission in suicidality has not been demonstrated with any prior oral antidepressant drug – indeed, antidepressant drugs carry a Black Box warning of increased suicide risk. Reduction in akathisia was first identified in the laboratory as a distinguishing feature of DCS and is the basis of the approved claims in the Company's Composition of Matter patents. Akathisia is often characterized as a state of agitation and motor restlessness that is associated with particularly impulsive and tragically effective attempts at suicide, such as hanging, shooting, jumping from buildings and in front of vehicles and trains. In this trial, a 75% relative difference was seen on the Barnes Akathisia Rating Scale (BARS), with two-sided P=0.076, which would be expected to achieve significance in a properly powered registration-sized trial. While reduction in akathisia is not proposed as a primary labeled indication, continued finding of a statistically significant reduction in this side effect would be highly supportive of a demonstrated primary endpoint of reduced suicidality and would provide clinical corroboration. Based on these findings and widespread adoption of ketamine as initial treatment for suicidal depression, the Company believes that NRX-101 may become the drug of choice for potentiating the effect of ketamine in patients with acute and subacute suicidality. The FDA recently affirmed to the Company that the Special Protocol Agreement for this indication remains in place, subject to the Company filing a New Drug Approval for ketamine, which is expected by July 2024. Moreover the Company aims to explore the role of NRX-101 as primary treatment for the much larger population (approximately 7 million in the US) of patients with bipolar depression who do not have active suicidality and, therefore, do not require prior treatment with intravenous ketamine. Aankondiging • Apr 20
NRx Pharmaceuticals, Inc. has completed a Follow-on Equity Offering in the amount of $2.0031 million. NRx Pharmaceuticals, Inc. has completed a Follow-on Equity Offering in the amount of $2.0031 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 607,000
Price\Range: $3.3
Discount Per Security: $0.264 Aankondiging • Apr 19
NRx Pharmaceuticals Demonstrates Compliance with the Nasdaq Bid Price Requirement in Listing Rule 5550(a)(2) NRx Pharmaceuticals, Inc. (‘NRx Pharmaceuticals’, ‘NRx’, the ‘Company’) announced that the company has received confirmation from Nasdaq that they have demonstrated compliance with the Nasdaq bid price requirement in Listing Rule 5550(a)(2) and has determined to continue the listing of the Company's securities on The Nasdaq Stock Market and is closing this matter. ‘We greatly appreciate the support of our investors through the process of protecting our Nasdaq listing,’ said Dr. Jonathan Javitt, Founder, Chairman and Chief Scientist of NRx Pharmaceuticals. ‘We are now poised to reach an important series of milestones, have the potential to be transformative to the company and dramatically enhance shareholder value. In addition to the near-term readouts and filings that we have identified for investors, recent unanticipated advances in the formulation of new forms of ketamine and potential use of NRX-101 in the treatment of complicated UTI and pyelonephritis have significant potential to create value for shareholders’. Aankondiging • Apr 18
NRx Pharmaceuticals, Inc. has filed a Follow-on Equity Offering. NRx Pharmaceuticals, Inc. has filed a Follow-on Equity Offering.
Security Name: Common Stock
Security Type: Common Stock Aankondiging • Apr 17
NRx Pharmaceuticals, Inc. Announces New Data on NRX-101 Demonstrating No Damage to Intestinal and Vaginal Flora in Validated Rodent Models Compared to Standard Antibiotics NRx Pharmaceuticals, Inc. announced new data that demonstrate that in a rodent model NRX-101 shows no measurable damage to either intestinal or vaginal flora, compared to the significant negative effect caused by drugs such as ciprofloxacin. Antibiotics commonly used to treat complicated urinary tract infections (cUTI) are associated with pseudomembranous colitis caused by Clostridium difficile (C diff) and vaginal yeast infections, primarily owing to their impact on normal flora. C. diff causes an intractable diarrhea in approximately 500,000 Americans each year and kills 1 in 11 Americans over age 65 who contract the infection. Costs of C. diff are estimated at $24,000 per patient and are significantly higher when C. diff occurs as part of a hospital admission. Whereas most antibiotics have substantial effect in the large bowel, the key component of NRX-101 (D-cycloserine) is entirely absorbed in the small intestine and excreted unmetabolized in the urine. If the nonclinical data reported are replicated in patients, NRX-101 could represent the first antibiotic for cUTI and pyelonephritis that has essentially no risk of causing C. diff infection or vaginal yeast infection. There is an extensive literature surrounding the use of D-cycloserine to treat tuberculosis and cases of C. Diff are unknown. D-cycloserine's effect as an antibiotic is based on its propensity to substitute for the amino acid alanine in the formation of the bacterial cell wall. Aankondiging • Apr 16
NRx Pharmaceuticals, Inc. Announces Development of New, Proprietary Formulation of HTX-100 (IV Ketamine) NRx Pharmaceuticals, Inc. announced that the Company has developed a novel, proprietary formulation of IV Ketamine for use as HTX-100. This new formulation has the key advantage of achieving neutral pH, in contrast to the acidic pH of generic formulations of ketamine. Acidic substances are tolerated when diluted for intravenous use, but cause pain and may cause skin ulcers if administered subcutaneously. This patentable invention may enable the administration of ketamine in insulin pump-like devices in the clinic setting, eliminating the requirement for intravenous infusion personnel.uroRx, Inc. previously executed a joint development agreement with a manufacturer of insulin pumps but has been awaiting a suitable, pH neutral formulation of ketamine. With this proprietary formulation, developed with partner Nephron Pharmaceuticals, a leading sterile products manufacturer, NRx is expected to generate one or more patents, such as composition of matter or formulation. Aankondiging • Apr 09
NRx Pharmaceuticals, Inc. Announces Data-Lock of Phase 2b/3 Trial of NRX-101 in Suicidal Treatment Resistant Bipolar Depression NRx Pharmaceuticals, Inc. announced that the Company has achieved data-lock in its Phase 2b/3 Suicidal Treatment Resistant Bipolar Depression Study with NRX-101. With data-lock, as forecast in last week's earnings call, the complete data set passed on for statistical analysis; top-line data release expected in April 2024. With positive data from this study and FDA comment, NRx becomes eligible to receive the balance of its first milestone (an additional $4 million) from partners Alvogen Inc. and Lotus Pharmaceuticals, Inc. (1745.TW). These partners would then be responsible for all future development costs in this indication. NRx is then poised to receive $320 million in further milestones along with mid-teen royalties on Net Sales. 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 Treatment Resistant B bipolar Depression. It is the only oral medication to have demonstrated both reduced symptoms of depression and reduced suicidal ideation in patients with bipolar depression, a lethal disease that claims the lives of one in five who live with it. The previous STABIL-B trial, (Ref. STABIL-B) resulted in the award of Breakthrough Therapy Designation for the use of NRX-101 following ketamine in hospitalized patients with Severe Bipolar Depression and Acute Suicidal Ideation and NRx was cleared by FDA to conduct a phase III trial in this regard under the Special Protocol Agreement. FDA then suggested that the Company explore whether NRX-101 might be applicable to the much larger population of patients with subacute suicidality who are cared for in the outpatient setting on a chronic basis. The purpose of this trial was to determine whether a signal could be detected that would support a much broader indication for NRX-101. Successful data in this regard would expand the potential market for NRX-101 from several hundred thousand patients per year to several million patients per year.The Phase 2b/3 trial 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 Montgomery-Asberg Depression Rating Scale (MADRS) 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. Aankondiging • Mar 29
NRx Pharmaceuticals Announces Reverse Stock Split to Maintain Nasdaq Listing NRx Pharmaceuticals, Inc. (‘NRx Pharmaceuticals’, the ‘Company’) announced that it intends to effect a reverse stock split of its common stock at a ratio of 1 post-split share for every 10 pre-split shares. The reverse stock split will become effective at 4:30 p.m. Eastern Time on April 1, 2024. The Company's common stock will continue to be traded on the Nasdaq Capital Market under the symbol NRXP and will begin trading on a split-adjusted basis when the market opens on Tuesday, April 2, 2024. ‘Given the company's progress over the past year, we have received consistent guidance from investors, analysts, and financial advisors that our shareholders are best served by establishing a share price that is within the charter of institutional investors and not subject to ‘penny stock’ rules. While a more modest reverse split may have achieved Nasdaq compliance, the board believes that today's action is most consistent with creating long term shareholder value. With data from important clinical trials in Suicidal Bipolar Depression and Chronic Pain in the near term, as well as a planned dividend of shares in HOPE Therapeutics to existing shareholders and expected filing of an NDA for ketamine in the second quarter, we believe the company is well positioned to be attractive to many larger investors,’ said Dr. Jonathan Javitt, Founder, Chairman and Chief Scientist of NRx Pharmaceuticals. Aankondiging • Mar 22
NRx Pharmaceuticals, Inc. to Report Q4, 2023 Results on Mar 28, 2024 NRx Pharmaceuticals, Inc. announced that they will report Q4, 2023 results After-Market on Mar 28, 2024 Aankondiging • Mar 05
NRX Pharmaceuticals Announces Last Patient, Last Visit in Its Phase 2B/3 Trial of NRX-101 in Suicidal Treatment Resistant Bipolar Depression NRx Pharmaceuticals, Inc. 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. The Phase 2b/3 trial 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. New Risk • Mar 02
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 17% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (17% average weekly change). Negative equity (-US$6.2m). Earnings have declined by 5.3% per year over the past 5 years. Revenue is less than US$1m. Minor Risks Shareholders have been diluted in the past year (34% increase in shares outstanding). Market cap is less than US$100m (US$32.7m market cap). Aankondiging • Feb 28
NRx Pharmaceuticals, Inc. has completed a Follow-on Equity Offering in the amount of $1.5 million. NRx Pharmaceuticals, Inc. has completed a Follow-on Equity Offering in the amount of $1.5 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 5,000,000
Price\Range: $0.3
Discount Per Security: $0.024 Aankondiging • Feb 27
NRx Pharmaceuticals, Inc. has filed a Follow-on Equity Offering. NRx Pharmaceuticals, Inc. has filed a Follow-on Equity Offering.
Security Name: Common Stock
Security Type: Common Stock
Security Name: Pre Funded Warrants
Security Type: Equity Warrant Aankondiging • Jan 24
Panel Grants NRx Pharmaceuticals Request for an Exception to Nasdaq Listing Rules Until April 16, 2024, to Demonstrate Compliance with the Rule On October 17, 2023, NRx Pharmaceuticals, Inc. (the “Company”) received formal notice from the Listing Qualifications Staff (the “Staff”) of The Nasdaq Stock Market LLC (“Nasdaq”) indicating that, based upon the Company’s non-compliance with the minimum bid price requirement for continued listing on The Nasdaq Global Market, as set in Nasdaq Listing Rule 5450(a)(1) (the “Rule”), the Company’s securities were subject to delisting unless the Company timely requested a hearing before the Nasdaq Hearings Panel (the “Panel”). The Company timely requested a hearing before the Panel, which hearing was held on January 4, 2024. On January 16, 2024, the Panel granted the Company’s request for an exception to the Nasdaq listing rules until April 16, 2024, to demonstrate compliance with the Rule. Such exception is subject to the following conditions: The Company filing all necessary documentation required to transfer its listing from the Nasdaq Global Market to the Nasdaq Capital Market on or before January 19, 2024; and The Company demonstrating compliance with Listing Rule 5550(a)(2) on or before April 16, 2024. The Company is diligently working to evidence compliance with the Rule; however, there can be no assurance that the Panel will determine to continue the Company’s listing or that the Company will be able to evidence compliance with the applicable listing criteria within the time period of any extension that may be granted by the Panel. Aankondiging • Jan 23
NRx Pharmaceuticals, Inc. Announces Completion of Enrollment of Its Phase 2b/3 Trial of NRx-101 in Suicidal Treatment Resistant Bipolar Depression NRx Pharmaceuticals, Inc. announced completion of enrollment 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. Enrollment of 74 patients exceeded the original target of 70 patients, in order to enhance statistical power of the study. 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. The Phase 2b/3 trial enrolled 74 patients with suicidal bipolar depression. This 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. Aankondiging • Jan 16
NRx Pharmaceuticals, Inc. Announces FDA Qualified Infectious Disease Product and Fast Track Designation of NRX-101 in Complicated Urinary Tract Infection and Pyelonephritis NRx Pharmaceuticals, Inc. announced that it has received Qualified Infectious Disease Product (QIDP) and Fast Track designation from the US FDA for NRX-101 in the treatment of complicated urinary tract infections (cUTI) and pyelonephritis. Receipt of QIDP designation confers Priority Review, and critically, five additional years of data-exclusivity to NRX-101's already strong Intellectual Property position. The FDA also granted NRX-101 Fast Track designation for cUTI, which additionally allows for rolling submission of the Company's New Drug Application. In addition to the marketplace protections conferred by QIDP designation in the US, NRx has composition of matter patent protection on NRX-101 through at least 2033 in all major global markets. The data that formed the basis of FDA's QIDP approval have been submitted for publication. On the basis of this advance, NRx is seeking partners with active involvement in urology, infectious disease and/or women's health for commercialization of NRX-101. The active antibiotic ingredient of NRX-101 is D-cycloserine (DCS) that was developed as an antibiotic in the 1950's and used worldwide for the treatment of tuberculosis. it fell out of favor with the development of trimethoprim/sulfa and various penicillins, cephalosporins, and tetracyclines, in part because of the CNS effects associated with DCS-induced blockade of the brain's NMDA receptor. In the course of its CNS research, NRx pharmaceuticals has demonstrated that small doses of lurasidone counteract those CNS effects, potentially providing a new therapeutic life to DCS as an antibiotic. Over the ensuing decades, increased antibiotic resistance has rendered standard treatments for UTI ineffective in many cases and today 3 million Americans suffer from cUTI requiring increasingly toxic antibiotics, increasingly frequent intravenous therapy, and increased need for hospital admission. Because DCS has the unique property of being highly concentrated, unmetabolized, in the urine with oral administration, the Company believes, and previous literature has suggested that DCS may effectively treat, and therefore help prevent, the need for intravenous and inpatient treatment of cUTI. Moreover, because DCS is rapidly absorbed and excreted in the urine, the Company is optimistic that NRX-101 will have a minimal tendency to disrupt the microbiome of the intestine and which can lead to secondary Clostridium difficile infection. C. diff associated colitis doubles hospital mortality and costs the American healthcare system up to $1.6 billion each year. Additionally, DCS has no known association with C. diff or with pulmonary fibrosis, a rare, lethal condition that has been associated with macrolide (tetracycline family) antibiotics. Aankondiging • Jan 02
NRx Pharmaceuticals Demonstrates Compliance with Nasdaq MVLS Standard NRx Pharmaceuticals, Inc. ("NRx Pharmaceuticals", the "Company") announced an update on plans to achieve compliance with Nasdaq market requirements related to minimum bid price and total Market Value of Listed Securities (MVLS). As has been previously disclosed, Nasdaq presented NRx with two deficiency notices, one related to failure to maintain the minimum $1 bid price and the other related to failure to maintain the minimum MVLS for the Nasdaq Global Market (i.e., and MVLS of $50 million). Because there were two simultaneous deficiencies, the Company did not qualify for a second automatic 180-day compliance period on the bid price deficiency. As was shared by the Company's CEO at the annual meeting of shareholders held on December 19, 2023, NRx has requested that Nasdaq move its listing to the Nasdaq Capital Market, where the MVLS is set at $35 million. The Company announced that it has demonstrated compliance with the $35 million MVLS since December 18, 2023, and aim to maintain compliance with this requirement going forward. Achieving compliance with the Nasdaq Capital Markets MVLS threshold renders NRXP eligible for a second 180-day compliance period to reach a bid price of $1. The Company will present its going-forward compliance plan to Nasdaq on January 4, 2024. That compliance plan is largely based on achieving clinical and regulatory milestones as outlined previously and summarized below. As part of that compliance plan, we are required to demonstrate a capacity to effect a reverse stock split if needed to achieve bid price compliance by the end of the second 180 period that occurs on April 15, 2024. Accordingly, we filed a Form 14A preliminary proxy statement on December 29, 2023 announcing a meeting of shareholders to be held on February 7, 2024, at which shareholders are asked to vote to authorize the Board of Directors to effect a reverse split, in the event that the Company does not reach compliance with the $1/share bid price by April 15, 2024. This is required by the Nasdaq committee to demonstrate the Company's commitment to regaining compliance. Based on the forward momentum that has been achieved, the Company does not anticipate a need to effect a reverse split. Should bid price compliance be reached prior to February 7, the shareholder meeting will be cancelled. Aankondiging • Dec 27
Nrx Pharmaceuticals Announces Election of Janet Rehnquist to Its Board of Directors NRx Pharmaceuticals, Inc. announced that Janet Rehnquist has been elected to the Company's Board of Directors where she will chair the compliance and the nominating committees. Ms. Rehnquist is an experienced healthcare lawyer who specializes in reimbursement and compliance matters. Previously, she served as Inspector General of the US Department of Health and Human Services and, before that as Assistant US Attorney for the Eastern District of Virginia. Price Target Changed • Dec 24
Price target increased by 7.1% to US$3.75 Up from US$3.50, the current price target is an average from 2 analysts. New target price is 730% above last closing price of US$0.45. Stock is down 58% over the past year. The company posted a net loss per share of US$0.60 last year. Aankondiging • Dec 18
NRx Pharmaceuticals, Inc. Announces FDA Clearance of its Investigational New Drug (IND) Application for NRX-101 in the Treatment of Complicated Urinary Tract Infections NRx Pharmaceuticals, Inc. announced that its Investigational New Drug Application (IND) for the use of NRX-101, the company's patented combination of D-cycloserine and lurasidone, for the treatment of complicated Urinary Tract infections (cUTI), received clearance from the US FDA. The D-cycloserine (DCS) component of NRX-101 is well known as an antibiotic and is excreted unmetabolized in the urine. However, the NMDA-antagonist effects of DCS led to its use in the United States, while it has remained a widely used anti-tuberculosis agent by the World Health Organization. NRx's patented discovery that combining DCS with small amounts of lurasidone counters the CNS side effects potentially and renders NRX-101 an important, patented antibiotic, just at a time when Americans are increasingly facing intravenous antibiotic therapy and even hospitalization and death from pathogens that were readily controlled a generation ago. As previously disclosed, the company sees the value for this program in an independent company dedicated to the development and commercialization of NRX-101 for cUTI. The company awaits the FDA's response to its request for Qualified Infectious Disease Product (QIDP) designation, expected next month. Aankondiging • Nov 23
NRx Pharmaceuticals, Inc., Annual General Meeting, Dec 19, 2023 NRx Pharmaceuticals, Inc., Annual General Meeting, Dec 19, 2023, at 11:00 US Eastern Standard Time. Agenda: To elect Janet Rehnquist as a Class II member of the Company’s Board of Directors, to serve until the 2026 annual meeting of stockholders or until the appointment, election, and qualification of her successor; to ratify the selection of Salberg & Company, P.A. as the Company’s independent auditors for the fiscal year ending December 31, 2023; to approve, on an advisory basis, the frequency of holding an advisory vote on executive compensation; and to transact such other business as may properly come before the Annual Meeting or any adjournments or postponements thereof. New Risk • Nov 17
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$27m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$27m free cash flow). Negative equity (-US$6.2m). Earnings have declined by 18% per year over the past 5 years. Revenue is less than US$1m. Minor Risks Share price has been volatile over the past 3 months (14% average weekly change). Shareholders have been diluted in the past year (19% increase in shares outstanding). Market cap is less than US$100m (US$24.4m market cap). Aankondiging • Nov 08
NRx Pharmaceuticals, Inc. to Report Q3, 2023 Results on Nov 14, 2023 NRx Pharmaceuticals, Inc. announced that they will report Q3, 2023 results After-Market on Nov 14, 2023 Aankondiging • Oct 28
NRx Pharmaceuticals Announces Further Alignment with FDA on Initiation of Registrational Trials for NRX-101 in the Treatment of Chronic Pain NRx Pharmaceuticals, Inc. announced further alignment with the FDA Division of Anesthesiology, Addiction Medicine, and Pain Medicine in connection with the development of NRX-101 for treatment of Chronic Pain. The communication took the form of a "Study May Proceed" letter, authorizing NRx to proceed with opening a pharmacokinetic study under the newly-established Investigational New Drug file for treatment of Chronic Pain. This is a formal letter that generally follows clearance of an IND and outlines nonclinical and clinical requirements suggested by the review division. The preclinical requirements identified by FDA for this new indication are consistent with the already-implemented preclinical requirements previously identified by the Division of Psychiatry Products for the use of NRX-101 to treat Bipolar Depression, although the duration of some nonclinical studies will be extended for the anticipated longer treatment duration associated with Chronic Pain. FDA advised NRx to focus on a specific type of pain in its initial registrational trials, which is consistent with NRx's plan to attempt to replicate the clinically-significant benefit previously identified in association with treatment of low back pain, which is also the subject of the recently completed DOD-funded trial. With this alignment in place and with the current inventory of manufactured NRX-101 on hand for clinical trial use, the Company now awaits results from the already-completed DOD-funded trial of D-cycloserine vs. placebo (www.clinicaltrials.gov NCT03535688) in order to confirm the previously-identified efficacy signal and dosing range. Aankondiging • Oct 24
NRx Pharmaceuticals Receives Formal Notice from the Listing Qualifications Staff of Nasdaq Regarding Non-Compliance with the Minimum Bid Price Requirement On October 17, 2023, NRx Pharmaceuticals, Inc. received formal notice from the Listing Qualifications Staff (the “Staff”) of The Nasdaq Stock Market LLC (“Nasdaq”) indicating that, based upon the Company’s non-compliance with the minimum bid price requirement for continued listing on The Nasdaq Capital Market, as set forth in Nasdaq Listing Rule 5550(a)(2) (the “Rule”), the Company’s securities were subject to delisting unless the Company timely requests a hearing before the Nasdaq Hearings Panel (the “Panel”). The Company plans to timely request a hearing before the Panel, which request will stay any further action by Nasdaq pending the issuance of a decision by the Panel and the expiration of any extension that the Panel may grant to the Company following the hearing. As previously disclosed in the Company’s Current Report on Form 8-K filed on April 21, 2023, the Company was provided with an initial compliance period of 180 calendar days to regain compliance with the Rule, which ultimately expired on October 16, 2023. The Company did not evidence compliance with the Rule by October 16, 2023, which resulted in the issuance of the Staff’s October 17, 2023 determination. The Company is diligently working to evidence compliance with the Rule; however, there can be no assurance that the Panel will determine to continue the Company’s listing or that the Company will be able to evidence compliance with the applicable listing criteria within the time period of any extension that may be granted by the Panel. Aankondiging • Oct 13
NRx Pharmaceuticals Announces Strategic Acceleration of its Plans to Develop Commercial Form of NRX-100 (intravenous ketamine) to Treat Acute Depression and Suicidality NRx Pharmaceuticals, Inc. announced a strategic acceleration of its plans to develop a commercial form of NRX-100 (intravenous ketamine) to treat acute depression and suicidality, based on recent data cooperation agreements and on changes in the regulatory environment. As previously announced, the Company has signed a Data Sharing Agreement to gain access to the patient level (anonymized) data from a major Ketamine study in France (BMJ 2022; 376). The findings of this trial demonstrate a dramatic effect of intravenous ketamine in reducing acute suicidality and depression, particularly in patients with bipolar depression. The findings of this trial confirm the results reported by Grunebaum and coworkers (Am J Psychiatry 2018;175:327) and numerous smaller trials. Two simultaneous and unexpected developments augment NRx's renewed focus on offering a commercial form of intravenous ketamine: A long-awaited trial of nasal ketamine for the same indication failed to meet its primary endpoints. The FDA issued a second warning letter on October 10, 2023 cautioning against the compounding of ketamine, which follows its February 16, 2022 warning letter regarding the compounding of nasal forms of ketamine. Sequential warning letters of this nature are frequently followed by enforcement actions, particularly in the case of a DEA scheduled, dangerous drug, such as ketamine. Without an approved form of intravenous ketamine for acute suicidality, its benefits will only be available to patients able to pay cash for off-label treatment, because unapproved therapies are not suitable for insurance reimbursement. Moreover, FDA's clear position regarding the illegality of compounded forms of ketamine is likely to further limit access to what appears to be a lifesaving drug. Although NRx has long held the belief that ketamine is not suitable as a long-term treatment for depression and suicidality because of its potential for neurotoxicity, addiction, and hallucination, the company has have long-recognized ketamine's unique ability to provide rapid remission from acute suicidality, provided a safe, oral drug can be implemented to maintain the life-saving effect. With the availability of what are now two clinical trials that demonstrate clinically-meaningful and statistically significant benefit of ketamine vs. both placebo and midazolam (active comparator), the company hope that a path to accelerated approval of NRX-100 (IV ketamine) as an agent for rapid reversal of suicidality as a prelude to long-term oral therapy can be identified. Preliminary estimates of this regulatory focused work show that this effort is within the company's current budget. Aankondiging • Oct 05
NRx Pharmaceuticals Announces FDA Permission to Proceed on Investigational New Drug (IND) Application for NRX-101 to Treat Chronic Pain NRx Pharmaceuticals, Inc. announced that FDA has given the company clearance to proceed with human trials to treat Chronic Pain under the Investigational New Drug (IND) application filed with the U.S. Food and Drug Administration (FDA) for the use of NRX-101. The IND application leverages pioneering research on the use of D-cycloserine (a key ingredient of NRX-101) in the treatment of chronic pain and the recent licensure by NRx of a US Patent for the use of D-cycloserine in the treatment of pain. NRX-101 in Chronic Pain Chronic pain is estimated to be a $72 billion industry with the potential to grow to a $120 billion industry by 2033. In June 2023, concurrent with announcement of the Alvogen partnership, the Company announced an expansion of its NRX-101 program to encompass treatment of chronic pain as the next focus on NRX-101's development. The company has announced the licensure of US Patent 8,653,120 related to the treatment of chronic pain with DCS and the addition of Dr. Apkar Vania Apkarian, Professor of Physiology, Anesthesia, Surgery, and Neuroscience Institute, Northwestern University Feinberg School of Medicine, to the NRx Scientific Advisory Board. Dr. Apkarian is the inventor of the patent and a global expert in pain research and has important experience studying DCS in chronic pain. D-cycloserine (DCS) has been shown to modulate the Pain Pathway at each point in the neural chain of pain: transmission at dorsal horn of the spinal cord, pain perception in the thalamus ("paleo brain"), and pain memory and processing between the paleo brain and the cortex. In experimental models and clinical studies, NMDA antagonists have demonstrated attenuation of pain and shown potential to reduce opioid craving. DCS has demonstrated no potential for addiction, unlike ketamine and other NMDA antagonists that bind to the "mu" opioid receptor. DCS was evaluated in a pilot study at Northwestern University and showed efficacy at the higher dose levels in the study (Schnitzer, 2016). DCS is currently being examined in a confirmatory trial funded by the US Department of Defense under the Congressionally Directed Medical Research Program. The trial seeks to recruit approximately 200 participants with chronic low back pain at Northwestern University (clinicaltrials.gov NCT03535688). Data collection is complete and statistical results are expected in the coming months. Research conducted by NRx Pharmaceuticals demonstrated a 25 µg/ml dose at which D-cycloserine becomes an NMDA antagonist. The 400mg dose presented in the confirmatory trial at Northwestern University is at the lower end of the threshold and suggests that the ability to increase the D-cycloserine dose beyond 400mg, where lurasidone is used to prevent CNS side effects in NRX-101. Aankondiging • Sep 07
NRx Pharmaceuticals, Inc. Announces New Data That Demonstrates Potent in Vitro Activity of NRx-101 NRx Pharmaceuticals, Inc. announced new data that demonstrate potent in vitro activity of NRX-101 (D-cycloserine + lurasidone) against reference strains of Urinary Tract pathogens known to cause complicated urinary tract infections (cUTIs). D-cycloserine (DCS) was originally developed as an anti-infective in the 1950's but was never labeled for treatment of UTI, because of the prevalent and then-effective use of common antibiotics. In recent years, however, cUTI is increasingly caused by pathogens that are resistant to common antibiotics and are increasingly likely to cause sepsis, a lethal condition. Approximately 17,000 deaths per year in the United States are attributed to genitourinary sepsis. The study, commissioned by NRx at Charles River Laboratories, is consistent with previously reported academic studies that demonstrate potency of DCS in antibiotic-resistant strains of urinary pathogens. Because NRx has already completed the phase 3 manufacture of NRX-101, the Company is in a position to immediately seek investigational human use for this indication, while continuing to develop NRX-101 for suicidal depression and chronic pain. Complicated UTI is increasingly common in the US, with an estimated 3 million new diagnoses annually. Antibiotic resistance is common as well. While the CNS effect of DCS is based on its inhibition of the brain's NMDA receptor, Cycloserine also inhibits cell-wall synthesis in various bacteria. NRX-101, a fixed dose combination of D-cycloserine and lurasidone, has been granted Fast Track Designation, Breakthrough Therapy Designation, a Special Protocol Agreement, and a Biomarker Letter of Support from the FDA for S-TRBD. Additionally, the product is being developed in chronic pain and PTSD. Up to 50% of individuals with bipolar disorder attempt suicide over their lifetime, and estimates indicate that up to 20% may succumb to suicide. The only FDA-approved treatment for patients with treatment-resistant suicidal bipolar depression remains electroconvulsive therapy. Conventional antidepressants can increase the risk of suicide in certain patients; hence their labels contain a warning to that effect. NRX-101 is a patented, oral, fixed dose combination of D- cycloserine and lurasid one, neither of which has shown addiction potential in preclinical models. Based on the results of a Phase 2 proof-of-concept study, NRX-101 received Breakthrough Therapy Designation from the FDA for the treatment of severe bipolar depression in patients with ASIB after initial stabilization with ketamine or other effective therapy. NRX-101 is one of the first oral antidepressants currently in late-stage clinical studies targeting the NMDA-receptor in the brain, which represents potentially a key new mechanism to treat depression with and without suicidality, as well as chronic pain, PTSD and other indications. Aankondiging • Aug 31
NRx Pharmaceuticals Announces Submission of an Investigational New Drug Application for NRX -101 in the Treatment of Chronic Pain NRx Pharmaceuticals, Inc. announced submission an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for the use of NRX-101 to treat Chronic Pain. The IND application leverages pioneering research on the use of D-cycloserine (a key ingredient of NRX-101) in the treatment of chronic pain and the recent licensure by NRx of a US Patent for the use of D-cycl closerine in the treatment of pain. Nonclinical and substantial clinical data are already on file with FDA for NRX-101, which has already been granted Breakthrough Therapy Designation for the treatment of suicidal Bipolar Depression. Aankondiging • Aug 30
NRx Pharmaceuticals, Inc. announced that it expects to receive $1.2 million in funding NRx Pharmaceuticals, Inc. announced that it has entered into a securities purchase agreement to issue 3,000,000 convertible preferred shares at a price of $0.40 per share and 3,000,000 warrants for the total gross proceeds of $1.2 million on August 29, 2023. The preferred shares will be convertible into 3,000,000 common shares of the company and warrants will also be convertible into shares at an exercise price of $0.4 per share. Recent Insider Transactions • Aug 24
Co-Founder recently bought US$64k worth of stock On the 22nd of August, Jonathan Javitt bought around 200k shares on-market at roughly US$0.32 per share. This transaction amounted to 1.4% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. This was Jonathan's only on-market trade for the last 12 months. New Risk • Aug 13
New major risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 15% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$35m free cash flow). Negative equity (-US$284k). Earnings have declined by 41% per year over the past 5 years. Revenue is less than US$1m. Minor Risks Share price has been volatile over the past 3 months (15% average weekly change). Shareholders have been diluted in the past year (19% increase in shares outstanding). Market cap is less than US$100m (US$26.1m market cap). Aankondiging • Aug 08
NRx Pharmaceuticals, Inc. to Report Q2, 2023 Results on Aug 14, 2023 NRx Pharmaceuticals, Inc. announced that they will report Q2, 2023 results After-Market on Aug 14, 2023 Aankondiging • Jul 30
NRx Pharmaceuticals Receives Written Notification from Nasdaq Regarding Non-Compliance with Nasdaq Listing Rule 5450(b)(2)(A) – Market Value of Listed Securities On July 20, 2023, NRx Pharmaceuticals, Inc. received a written notification (the ‘Notice’) from the Nasdaq Stock Market LLC (‘Nasdaq’) indicating that the company was not in compliance with Nasdaq Listing Rule 5450(b)(2)(A) – Market Value of Listed Securities (‘MVLS’) because the Company has not maintained a minimum MVLS of $50,000,000 for the last thirty-three (33) consecutive business days. Nasdaq’s Notice has no immediate effect on the listing of the common stock on The Nasdaq Global Market and, at this time, the common stock will continue to trade on The Nasdaq Global Market under the symbol ‘NRXP’. Pursuant to Nasdaq Listing Rule 5810(c)(3)(C), the Company has been provided an initial compliance period of 180 calendar days, or until January 22, 2024, to regain compliance with the MVLS requirement. To regain compliance, the Company’s MVLS must meet or exceed $50,000,000 for a minimum period of ten consecutive business days prior to January 22, 2024. If the Company does not regain compliance within the allotted compliance period Nasdaq will provide notice that the Company’s shares of common stock will be subject to delisting and may potentially be traded on the Over-the-Counter market thereafter. Aankondiging • Jun 13
NRx Pharmaceuticals, Inc. has completed a Follow-on Equity Offering in the amount of $6.285501 million. NRx Pharmaceuticals, Inc. has completed a Follow-on Equity Offering in the amount of $6.285501 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 9,670,002
Price\Range: $0.65
Discount Per Security: $0.04225
Transaction Features: Registered Direct Offering Aankondiging • Feb 14
NRx Pharmaceuticals, Inc. Reports Minutes of U.S. Food and Drug Administration Meeting on Development of NRX-101 to Treat Severe Bipolar Depression in Patients with Suicidality NRx Pharmaceuticals, Inc. reported the minutes of a Type B meeting with the U.S. Food and Drug Administration's Division of Psychiatry Products held on January 11, 2023. The purpose of the meeting was to discuss requirements for submission of a New Drug Application for NRX-101. FDA noted in written correspondence that the Special Protocol Agreement (SPA), granted in April 2019 remains in effect. Additionally, the FDA suggested during the meeting that a broadening of the addressable population of the indication (under the SPA or otherwise) to patients with Severe Bipolar Depression and Recent Acute Suicidality regardless of how the initial stabilization was accomplished could represent a more straightforward development program. This broader indication would enable the Company to potentially demonstrate the use of NRX-101 to maintain stabilization from suicidality in patients stabilized either with ketamine or with other standard of care therapeutic approaches. This broader indication is not expected to delay the acute care trial expected to be completed in 2023. FDA noted that, should the results of such a study be driven primarily by subjects stabilized with ketamine, a New Drug Application for ketamine would also be required. The FDA further guided the Company to broaden the study of NRX-101 to include chronic/intermittent treatment of patients with Bipolar Depression and suicidality. This could enable a pathway for the use of NRX-101 by a broader segment of the approximately 7 million individuals in the U.S. with Bipolar Disorder on a long-term basis. A portion of this population is already being addressed in the Company's ongoing phase 2 trial, which recently passed its first Data Safety Monitoring Board (DSMB) safety review. Based on this guidance, the Company is considering expanding its current phase 2 clinical trial to a potential registration study now that the manufacture of phase 3/commercial-stage NRX-101 has been completed. The Company previously announced completion of a Type C meeting in which FDA agreed to the Company's Chemical Manufacturing Control and stability program for drug manufacture. As previously announced, the Company currently expects a DSMB evaluation of efficacy data from this trial by the end of the first quarter of 2023. The FDA further advised the Company that as a chronic, or chronic-intermittent treatment, the safety database requirement under ICH guidelines for NRX-101 should be 1,500 patients, with at least 100 treated for 1 year. The Company is evaluating the timing and cost of expanding clinical access to this larger population. In addition to its ongoing clinical trials, the Company is considering augmenting its safety database via an expanded access program, which is now enabled by the availability of commercial-stage NRX-101 and is expected under federal law governing Breakthrough Therapy Designation. The Company will seek cost reimbursement for operating this Expanded Access Program as permitted under current FDA regulations. In related comments, the FDA accepted the Company's rationale for deferring pediatric and adolescent studies with NRX-101 until after drug approval and advised the Company to include this rationale in its regulatory filings. The FDA will consider the Company's submission of an Advice Request to evaluate waiving or deferring chronic carcinogenicity testing as a post-approval commitment. Finally, the FDA's Controlled Substances Staff advised the Company to closely monitor abuse-related adverse events and possible cases of abuse during clinical trials. Aankondiging • Jan 20
NRx Pharmaceuticals, Inc. Provides Progress Update on Interactions with the FDA regarding Path to NDA Submission for NRX-101 NRx Pharmaceuticals, Inc. announced that it had a meeting and a written response from the Food and Drug Administration (FDA) last week regarding its lead compound, NRX-101. In response to a request for Type C guidance on the chemistry, manufacturing and controls (CMC) aspects of the NRX-101 program, FDA provided Written Responses on January 10th. As previously announced in October 2022, an updated NRX-101 module 3 was submitted to add the intended commercial manufacturer to the IND. With FDA's written response, it appears that NRx Pharmaceuticals has reached alignment with the FDA regarding its proposed registration manufacturing plan. A Type B meeting with the FDA was held on January 11, 2023. Minutes of the meeting are expected to be available in approximately 30 days. Aankondiging • Jan 04
NRx Pharmaceuticals, Inc. Initiates Phase 3 Trial Treating Patients with Bipolar Depression with Acute Suicidality - First Clinical Site Contracted NRx Pharmaceuticals, Inc. announced that its first clinical trial site has been contracted (with others expected in near future) and that first dosing of patients is expected in early 2023. This Phase 3 clinical trial of NRX-101 is for the treatment of Severe Bipolar Depression with Acute Suicidal Ideation and Behavior ("SBD-ASIB"), a lethal condition that currently takes the lives of thousands of Americans each year. NRX-101 is the first investigational medicine to target this condition, for which the only currently approved treatment is Electroconvulsive Therapy. Based on preliminary efficacy demonstrated in the Company's Phase 2 STABIL-B trial1, the FDA awarded Breakthrough Therapy Designation to NRX-101 in 2018. The Company subsequently received an FDA agreement for the Phase 3 trial under a Special Protocol Assessment which indicated that based on the information submitted [FDA] agrees that the design and planned analysis of study adequately address the objectives necessary to support a regulatory submission. To strengthen compliance, the Company is using electronic compliance monitoring. Additionally, the Company will perform independent internal confirmation of depression and suicidality ratings as was done in the STABIL-B trial. In that prior trial, these methods enabled a high compliance with study medication and high concordance between the psychometric ratings ascertained at study sites and those confirmed by the Company's team of psychometric raters. A Type B meeting with the FDA's Psychiatry Division is scheduled in mid-January 2023. The purpose of this meeting is to align on the registration strategy for NRX-101 in the initial indication for treatment of adults with SBP-ASIB. 
