ketamine intravenous (NRX100) / NRx Pharma - LARVOL DELTA

NRx Pharmaceuticals…Reports Update from the FDA Revising Previous Major Amendment to a Minor Amendment for Preservative-free Ketamine (GlobeNewswire) - "The acknowledgement letter revised the GDUFA goal date to November 10, 2026, citing that the reclassified amendment will not require a substantial expenditure of FDA resources....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."

ANDA • FDA event • Depression • Suicidal Ideation

Antidepressant-like effects of ketamine involve CX3CL1/CX3CR1 signaling-mediated synaptic plasticity in the mPFC. (PubMed, Transl Psychiatry) - "Ketamine, a non-competitive N-methyl-D-aspartate acid (NMDA) receptor antagonist, produces rapid and sustained antidepressant actions, but the underlying molecular mechanism remains unclear. Furthermore, pretreatment with AZD8797 (0.8 mg/kg, i.p., twice a week) completely blocked ketamine's antidepressant-like behavioral effects and eliminated ketamine-induced enhancement in the synaptic plasticity; intra-mPFC microinjection with AAV-CX3CR1-siRNA also prevented ketamine's behavioral effects and beneficial effects on the synaptic plasticity. These findings demonstrated that CX3CL1/CX3CR1 signaling-mediated synaptic plasticity played essential roles in ketamine's antidepressant-like effects, which opened a new door to targeting chemokines to improve depression symptoms."

Journal • CNS Disorders • Depression • Mood Disorders • Psychiatry • CX3CL1 • CX3CR1

NRx Pharmaceuticals, Inc…announces 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. (GlobeNewswire) - "NRx conducted a meeting with leadership of the FDA Office of Generic Drugs in which support was voiced for the potential approval of the Abbreviated New Drug Application within the current review cycle. 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."

FDA event • Depression

NRx Pharmaceuticals…Announces FDA Labeling Alignment for NRx’s Preservative-Free Ketamine Application (NRx Pharma Press Release) - "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."

FDA event • Depression • Suicidal Ideation

NRx Pharmaceuticals…Confirms Path to New Drug Application with Real World Data and Broader Proposed Indication for NRX-100 (ketamine) Following Type C FDA Meeting (The Manila Times) - "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....Company intends to sumbit its New Drug Application for NRX-100 by June 2026."

FDA event • FDA filing • Depression • Suicidal Ideation

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 Manila Times) - "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...In preliminary comments ahead of meeting, FDA advised NRx that no additional nonclinical data would be required for review of NRx’s New Drug Application and that no bridging studies would be needed..."

FDA event • Psychiatry • Suicidal Ideation

NRx Pharmaceuticals (Nasdaq:NRXP) Announces 70,000 Patient Data on Real World Use of Ketamine for Treatment of Suicidal Depression to be Submitted to the FDA in Support of NRX-100 Approval (GlobeNewswire) - "Analyses suggested that clinical response to intravenous ketamine is consistent with prior randomized trial data and compares favorably to currently-approved products."

Real-world evidence • Depression • Suicidal Ideation

NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Reports Third Quarter 2025 Financial Results and Provides Corporate Update (GlobeNewswire) - "NRx has refiled its Abbreviated New Drug Application for KETAFREE (preservative free ketamine), received supportive correspondence from FDA, and expects Q2 2026 GDUFA date....A New Drug Application ('NDA') for NRX-100 for suicidal depression, originally initiated during the fourth quarter of 2024, is expected to be completed in the fourth quarter 2025 with the addition of Real World Efficacy Data drawn from more than 60,000 patients treated for depression with intravenous ketamine compared to 6,000 patients treated with intranasal S-ketamine to be submitted as part of the NDA."

ANDA • FDA filing • Bipolar Disorder • Depression • Suicidal Ideation

Sustained antidepressant actions of ketamine involve TAMM41-mediated transfer of astrocytic sigma-1 receptor to neuron. (PubMed, Mol Psychiatry) - "Our findings reveal that astrocytic TAMM41 underlies the sustained antidepressant effect of ketamine through exosomal delivery of S1R to neurons, offering potential for new strategies in depression treatment. Considering the advantages of human red blood cells and therapeutic mRNA, our results also provide a promising avenue that warrants further translational and clinical exploration."

Journal • CNS Disorders • Depression • Psychiatry

NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Announces Expanded Access Policy for NRX-100 (preservative-free ketamine) (GlobeNewswire) - "Upon physician request, NRx Pharmaceuticals may make 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...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....Adequate supply of the investigational drug is available."

Commercial • Bipolar Disorder • Depression • Suicidal Ideation

A retrospective analysis of ketamine intravenous therapy for post-traumatic stress disorder in real-world care settings. (PubMed, Psychiatry Res) - "KIT is associated with reduced PTSD and depression symptoms in a community sample, with the most substantial gains occurring early in treatment. These findings support KIT as a promising treatment option for PTSD patients."

Journal • Real-world evidence • Retrospective data • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Post-traumatic Stress Disorder • Psychiatry

NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Granted FDA Fast Track Designation for NRX-100 for Suicidal Ideation in Patients with Depression, including Bipolar Depression (PRNewswire) - "This designation for NRX-100 as a standalone drug is a 10-fold expansion of the addressable population for NRX-100...The Company has applied for a CNPV, which has the potential to substantially shorten the review cycle for NRX-100....Under the terms of the Fast Track program, NRx will be posting an expanded access policy for NRX-100 in the next two weeks and seeking a meeting with FDA leadership to finalize the data to be submitted under the Accelerated Approval / CNPV application."

Fast track • Bipolar Disorder • Depression • Suicidal Ideation

NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Announces Filing of Commissioner's National Priority Voucher Application for Intravenous Ketamine (NRX-100) (PRNewswire) - "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."

FDA event • Depression • Suicidal Ideation

NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Files Abbreviated New Drug Application (ANDA) for Preservative-Free IV Ketamine (PRNewswire) - "NRx Pharmaceuticals...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....Accordingly, NRx is seeking priority review from FDA."

ANDA • Depression • Suicidal Ideation

NRx Pharmaceuticals Inc. (NASDAQ: NRXP) Announces $10.3 Million Financing to Expand HOPE Clinic Network, Advances FDA Drug Approval (PsychedelicNewsWire (PNW)) - "The company’s wholly owned subsidiary, HOPE Therapeutics, Inc...has signed a term sheet for $7.8 million in debt financing with Universal Capital, LLC...The funds will support HOPE’s clinic acquisition strategy...Together with a separate strategic investment, for which a financing term sheet was signed earlier, HOPE expects to deploy $10.3 million in acquisition capital in the near term, once both agreements are closed...HOPE’s expansion takes place as NRx moves closer to FDA approval for its proprietary ketamine formulation, NRX-100. The drug, a preservative-free IV ketamine therapy for suicidal depression, completed the stability and sterility testing needed for its New Drug Application ('NDA'). The NDA is on track to be filed in Q2 2025...In parallel, the company is advancing NRX-101, an oral therapy for bipolar depression with suicidality or akathisia....A filing for accelerated approval is expected later in 2025, with a PDUFA date anticipated by year-end."

FDA filing • Financing • Bipolar Disorder • Depression • Suicidal Ideation

NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) and HOPE Therapeutics™, Inc. Selected to Present at the Wall Street Conference on May 21, 2025, in Palm Beach, Florida (Streetinsider.com) - "NRx Pharmaceuticals, Inc...announced that that Jonathan Javitt, MD, MPH, Founder, Chairman and Chief Executive Officer of NRx Pharmaceuticals and Co-CEO of HOPE Therapeutics, will be presenting a Company update at the upcoming Wall Street Conference, taking place on May 21, 2025 in Palm Beach, FL. NRx is one of six companies invited to present....NRx will be discussing recent progress towards FDA approval of NRX-100 (preservative-free ketamine) and upcoming acquisitions of HOPE clinics providing state-of-the-art care for suicidal depression, PTSD, and related disorders."

Clinical • Commercial • CNS Disorders • Depression • Suicidal Ideation

HOPE Therapeutics, Inc. and NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) to Host Investor Event at Mar-A-Lago Club on May 8, 2025 (PRNewswire) - "Key Topics to be Discussed, based on previously disclosed information: Recently announced HOPE clinic acquisitions and potential to scale HOPE's interventional psychiatry network; Plans for integration of digital health solutions, including CRM-based technology and telepsychiatry capabilities, to unify clinical operations across the HOPE network; Status of the New Drug Application (NDA) for NRX-100 (preservative-free IV Ketamine), following FDA's grant of a $4.3 million filing fee waiver, for treating suicidal depression; Recent filing of a patent for preservative-free ketamine (NRX-100). If granted, the patent could provide market exclusivity for NRX-100 into 2045; Breakthrough Therapy Designation of NRX-101; currently preparing to file an NDA for Accelerated Approval in patients with bipolar depression and suicidality or akathisia."

Clinical • CNS Disorders • Suicidal Ideation

NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Files Patent Application for NRX-100, its Proprietary, Preservative Free Formulation of IV Ketamine (PRNewswire) - "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."

Patent • Depression • Suicidal Ideation

NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Announces FDA Award of Filing Fee Waiver for Upcoming NRX-100 (preservative free ketamine) New Drug Application to Treat Patients with Suicidal Depression (PRNewswire) - "NRx Pharmaceuticals, Inc...today 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 for NRX-100 with currently-available corporate resources. The NDA filing is anticipated by the end of the second quarter of this year (Q2 2025)....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 electroshock therapy in treating various forms of depression, including patients with active suicidal ideation."

Commercial • FDA filing • Depression • Suicidal Ideation

Impact of esketamine intravenous analgesic pump on pain and depression post-cesarean. (PubMed, BMC Surg) - "The use of the Esketamine Intravenous Analgesic Pump significantly reduces postoperative pain and the incidence of postpartum depression within the first 14 days. It promotes early recovery and breastfeeding in postpartum women without significant adverse reactions, making it a valuable addition to postoperative care."

Journal • Retrospective data • CNS Disorders • Depression • Mood Disorders • Pain • Postpartum Depression • Psychiatry

NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update (PRNewswire) - "Initiated filing of a New Drug Application ('NDA') to the FDA for NRX-100 (IV Ketamine) for the treatment of Suicidal Depression; planned filing of an NDA for Accelerated Approval under Breakthrough Designation and Priority Review of NRX-101 for the treatment of bipolar depression in people at risk of akathisia. Both have anticipated PDUFA dates prior to December 31, 2025."

FDA approval • FDA filing • Bipolar Disorder

NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Advances Relationship with Anson Funds with $8.9 Million Financing, Including Above the Market Equity and Senior Secured Debt (PRNewswire) - "NRx Pharmaceuticals...today announced that it has entered into a binding agreement for a registered direct offering of its common stock with expected gross proceeds of $3.5 million (the "Financing") with certain institutional investors. The Company also intends to issue certain senior secured convertible promissory notes (the 'Notes') with expected gross proceeds of $5.4 million to the same institutional investors pursuant to that certain securities purchase agreement dated August 12, 2024 (the 'Note Issuances'). The Company intends to use the net proceeds from the Financing and the Note Issuances to support, among other things, the New Drug Application filing of its two lead products, NRX-100 and NRX-101, the launch of HOPE Therapeutics, and the potential addition of new products to its pipeline."

Financing • Depression • Suicidal Ideation

NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Files Initial Section of U.S. New Drug Application to the FDA for NRX-100 (IV Ketamine) for the Treatment of Suicidal Depression (PRNewswire) - "NRx Pharmaceuticals, Inc...today 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)...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."

FDA filing • Depression • Suicidal Ideation

HOPE Therapeutics, Inc. and NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Announce Dr. Jonathan Javitt and Dr. David Feifel to Present Keynote Address, Beyond Ketamine Monotherapy: Combined Interventional Treatment of Suicidal Depression and PTSD, at the 8th Annual Neuroscience Innovation Forum in San Francisco (PRNewswire) - "HOPE Therapeutics...and...NRx Pharmaceuticals, Inc...today announced that Jonathan Javitt MD MPH...and Prof. David Feifel MD PHD...will present the Keynote Address at the 8th Annual Neuroscience Innovation Forum on January 12, 2025, at the Marines' Memorial Club in San Francisco at 10:30am PT...The keynote will focus on the integration of NMDA-targeted drug therapy (such as ketamine) with other emerging modalities such as Transcranial Magnetic Stimulation (TMS) and Digital Therapeutics to produce synergistic therapeutic effects that will permanently alter the clinical trajectory of patients with suicidal depression, PTSD, and other debilitating neuropsychiatric conditions for which there is a great need for better treatments....Milestones: 1Q 2025 - Planned completion of NRX-100 filing with the FDA; 1Q 2025 - Targeted NDA filing for NRX-101 (Oral DCS/Lurasidone) for Accelerated Approval; 1Q 2025 - Further HOPE clinic acquisitions."

Clinical • Commercial • FDA filing • Bipolar Disorder • Depression • Suicidal Ideation

NRx Pharmaceuticals (NASDAQ:NRXP) to Proceed with Two New Drug Applications in 2024; NRX-101 has Been Returned to the Company for Filing (PRNewswire) - "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."

FDA filing • Bipolar Disorder • CNS Disorders • Depression • Suicidal Ideation