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. (NASDAQ: NRXP) is a clinical-stage biopharmaceutical company whose news flow centers on its NMDA-based drug pipeline and interventional psychiatry operations. Company announcements frequently highlight progress with NRX-100, a preservative-free intravenous ketamine formulation, and NRX-101, an oral D-cycloserine/lurasidone combination, both aimed at serious central nervous system disorders such as suicidal depression and suicidal bipolar depression.
Investors following NRXP news can expect updates on FDA interactions, including Fast Track and Breakthrough Therapy designations, Abbreviated New Drug Application (ANDA) milestones for preservative-free ketamine, and New Drug Application (NDA) activities. The company also reports on the use of large Real World Evidence datasets to support potential Accelerated Approval pathways for NRX-100 in suicidal ideation associated with depression and bipolar depression.
Another recurring theme in NRx Pharmaceuticals’ news is the expansion of its HOPE Therapeutics subsidiary, which operates interventional psychiatry clinics. Releases describe clinic acquisitions, strategic interests in practices, and deployment of treatments such as ketamine-based therapies, Transcranial Magnetic Stimulation (TMS), Hyperbaric Oxygen Therapy, and digital therapeutics for suicidal depression, PTSD, and related conditions. Updates often cover new treatment protocols that combine TMS with D-cycloserine and other medications.
NRXP news items also include corporate developments such as conference presentations, corporate update calls, financing transactions, and changes in independent registered public accounting firms, as reflected in SEC filings. For investors and observers, the news stream provides ongoing insight into NRx Pharmaceuticals’ clinical progress, regulatory steps, clinic network growth, and capital markets activity related to its focus on Neuroplastic Therapies and suicidal depression.
NRx Pharmaceuticals (Nasdaq: NRXP) received a positive FDA Office of Generic Drugs Discipline Review Letter on its preservative-free ketamine ANDA, with requested changes labeled “Minor” and updates to prior stability data.
FDA leadership expressed support for completing review within the current cycle and the company is targeting Summer 2026 approval; NRx is also preparing an NDA to align ketamine labeling for depression and suicidality.
NRx Pharmaceuticals (Nasdaq:NRXP) welcomed a Presidential Executive Order signed April 18, 2026 to accelerate approvals of psychedelic medications for depression, PTSD, and suicidality.
The company has Fast Track designation and received FDA guidance ahead of an upcoming New Drug Application for NRX-100 (preservative-free ketamine) and has applied for a Commissioner’s National Priority Voucher to support that NDA.
NRx Pharmaceuticals (Nasdaq: NRXP) launched NRx Defense Systems, a Florida R&D subsidiary led by Dr. Dennis K. McBride to develop Combined Neuroplastic Therapy pairing D-cycloserine (NRX-101) with robotic-enabled Transcranial Magnetic Stimulation for military and first responder use.
The initiative partners with Zeta Surgical, whose AI neuronavigation received FDA 510(k) clearance in October 2025, and plans a prototype unveiling at the Clinical TMS Society meeting June 4-6, 2026. The company expects future R&D participation on a non-dilutive basis to current shareholders.
NRx Pharmaceuticals (Nasdaq: NRXP) named Glenn Tyson as its first Chief Commercial Officer on April 13, 2026. Tyson brings 25 years of commercial experience and clinical background to prepare for commercialization of a preservative‑free ketamine ANDA and a planned NDA to expand IV ketamine labeling to depression and suicidality.
The company also highlighted NRX‑101 (D‑Cycloserine) with prior Breakthrough Therapy recognition and plans to build market‑access, sales, and distribution ahead of potential launches.
NRx Pharmaceuticals (Nasdaq: NRXP) received a letter from the FDA Office of Generic Drugs indicating preliminary alignment on labeling for its preservative-free ketamine Abbreviated New Drug Application. Label comments were limited to minor formatting; the company expects to submit a final label this month and anticipates a GDUFA decision in Summer 2026.
The company previously received a preliminary determination of bioequivalence. NRx says the product is U.S.-manufactured and could help augment domestic ketamine supply during current backorders; the labeling remains subject to final supervisory review.
Hope Therapeutics (Nasdaq: NRXP) announced a strategic partnership with Emobot to deploy its AI-powered Depression Thermometer across Hope’s interventional psychiatry clinics, integrating passive smartphone monitoring of facial expressions, vocal tone, and actigraphy to detect early relapse in TRD.
Preliminary pooled validation across three prospective studies showed concordance with MADRS (r=0.89) and PHQ-9 (r=0.83); Hope expects the tool to enable timely "recapture" interventions and improve patient outcomes.
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.