Welcome to our dedicated page for Nrx Pharmaceuticals news (Ticker: NRXP), a resource for investors and traders seeking the latest updates and insights on Nrx Pharmaceuticals stock.
NRx Pharmaceuticals, Inc. reports clinical, regulatory, manufacturing, and subsidiary developments for a biopharmaceutical business focused on neuroplastic therapies for depression, PTSD, suicidality, and related conditions. Company updates center on NRX-100 preservative-free ketamine, NRX-101 as a D-cycloserine/lurasidone fixed-dose combination, FDA communications, generic-drug and new-drug application pathways, and clinical work involving treatment-resistant depression and suicidality.
Recurring news also covers commercial manufacturing preparations, drug-shortage context for ketamine injection, robotic-enabled transcranial magnetic stimulation initiatives through NRx Defense Systems, and interventional psychiatry activity through HOPE Therapeutics. Additional company developments include partnerships involving digital monitoring tools, leadership appointments, and research programs serving military, first-responder, and broader behavioral-health settings.
NRx Pharmaceuticals (Nasdaq: NRXP) reported full-year 2025 results and operational progress including $7.8 million cash at year-end, conversion of all previously issued convertible debt to common stock, and reduced loss from operations to $16.2 million. The company cited a favorable FDA bioequivalence signal for preservative-free ketamine and anticipates at least one ANDA approval in Q3 2026.
NRx also reported first clinic revenue from five HOPE Therapeutics sites, a nationwide partnership with neurocare AG for TMS clinics, a Type C FDA meeting on NRX-100, and filing of an IND for NRX-101.
NRx Pharmaceuticals (Nasdaq: NRXP) will report full year 2025 financial results and provide a corporate update on March 24, 2026. The company will host a conference call at 8:00am ET covering FY2025 results and progress across its drug development programs and the HOPE Therapeutics clinical network.
A live webcast will be available on the company's investor site and telephone dial-ins are provided for domestic and international participants.
NRx Pharmaceuticals (Nasdaq: NRXP) said the FDA Office of Generic Drugs told the company it has not identified bioequivalence deficiencies for NRx’s preservative-free ketamine ANDA; the communication is preliminary pending final supervisory review. NRx expects an FDA GDUFA decision in Summer 2026.
NRx aims to offer the first ketamine formulation free of benzethonium chloride, anticipates three years room-temperature stability, has filed patents, and plans U.S. manufacturing to support domestic supply resilience.
NRx Pharmaceuticals (Nasdaq:NRXP) received confirmatory FDA Type C meeting minutes outlining a path to a New Drug Application for NRX-100 (preservative-free ketamine) with a broader proposed indication to treat severe depression, including patients with suicidal ideation.
The FDA confirmed willingness to consider existing adequate and well-controlled trials as Substantial Evidence of Efficacy together with Real World Evidence from Osmind, requested patient-level data, and did not require additional clinical trials. NRx intends to submit an NDA by June 2026.
HOPE Therapeutics (Nasdaq: NRXP) opened a Palm Beach, FL clinic on March 9, 2026, offering one‑day interventional psychiatry treatments for depression and PTSD that combine ketamine and other neuroplastic drugs, transcranial magnetic stimulation (TMS), hyperbaric oxygen, and physician‑led psychotherapy.
Peer‑reviewed publications cited an 87% clinical response rate for a short‑term TMS plus neuroplastic medication protocol; pilot programs with added hyperbaric oxygen reported a 90% return to full function rate. HOPE cites a nationwide partnership with neurocare AG and is now accepting patients by phone.
NRx Pharmaceuticals (Nasdaq: NRXP) appointed Prof. Joshua C. Brown, MD, PhD, as Chief Medical Innovation Officer effective March 2, 2026. Prof. Brown is a TMS pioneer, Harvard-affiliated clinician-scientist with >$20M in federal funding, and will guide NRx's work combining TMS with neuroplastic medications including NRX-101.
He will collaborate with NRx leadership on development programs and an FDA Investigational New Drug application to test a combined therapy for PTSD and depression in first responders and military personnel.
NRx Pharmaceuticals (Nasdaq: NRXP) completed a Type C meeting with FDA leadership on Feb 17, 2026 and received oral guidance that supports a path to a New Drug Application for NRX-100 (preservative-free ketamine).
The company plans to combine existing adequate, well-controlled trial data with Real World Evidence from >65,000 patients and will seek a broader indication for treatment-resistant depression with suicidality. FDA preliminarily advised no additional nonclinical data or bridging studies would be required. Final meeting minutes and a finalized statistical analysis protocol for the RWE dataset are pending.
NRx Pharmaceuticals (Nasdaq: NRXP) will hold its 2025 annual meeting of stockholders on March 23, 2026 at 10:00 a.m. ET in a virtual-only format at https://www.cstproxy.com/nrxpharma/2026. The Board set a record date of February 12, 2026 for stockholders entitled to notice and to vote. The company said its proxy statement, to be filed with the SEC prior to the meeting, will describe meeting matters and voting procedures.
Because the meeting date is more than 60 days after the prior meeting anniversary, the advance-notice deadline under the bylaws for stockholder proposals and director nominations (other than Rule 14a-8 submissions) is the close of business on January 26, 2026. Submissions must follow the bylaws and be delivered by hand, overnight courier, or certified/registered mail to the company’s principal executive offices.
Bright Mountain Media (OTCQB: BMTM) released an on-demand webinar, “How Connected Research Helped Aruba Reimagine Tourism Marketing,” detailing a sub-30-minute case study of Aruba Tourism Authority, Big Village, and Deep Focus. The campaign shifted messaging to attitudinal segments, linked media activations to CRM, and reportedly delivered record visitation and improved marketing ROI. The campaign won a Gold Magellan Award and Shorty Impact recognition. The company also disclosed CEO Matt Drinkwater purchased 299,500 shares on December 10, 2025 (Form 5 filed).
NRx Pharmaceuticals (Nasdaq: NRXP) will submit real-world evidence from over 70,000 patients treated with intravenous ketamine or nasal S-ketamine to the FDA to support an Accelerated Approval application for NRX-100 (preservative-free ketamine) under Fast Track designation for treatment of suicidal ideation in depression, including bipolar depression.
The RWE, supplied by Osmind, includes nearly 1 million treatment sessions, continuous vitals, safety elements, and a prior 20,000-patient analysis showing rapid resolution of depression and suicidality.