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) presented at the Global Passion Project symposium, announcing plans for the Fall 2025 launch of HOPE Therapeutics clinics. The company introduced a groundbreaking residential program combining neuroplastic treatments including ketamine, transcranial magnetic stimulation, and hyperbaric oxygen therapy for treating suicidal depression, PTSD, and cognitive dysfunction.
The company recently secured $8.8 million in funding from biotech investors through a clean common stock offering. Notable developments include Matthew Rockefeller joining HOPE Therapeutics' Advisory Board and plans for establishing a flagship location in Palm Beach, FL. The combined treatment approach aims to achieve over 90% response rates, significantly higher than the 60% rates typically seen with individual therapies.
NRx Pharmaceuticals (NASDAQ:NRXP) has announced its expanded access policy for NRX-100 (preservative-free ketamine) following FDA's Fast Track designation for treating suicidal ideation in patients with depression, including bipolar depression.
The company will make NRX-100 available through expanded access for patients with serious or life-threatening suicidal depression who haven't responded to current treatments. According to CDC data, approximately 13 million adults consider suicide annually, with one American dying from suicide every 11 minutes.
Eligible patients must meet specific criteria, including having a serious condition unresponsive to approved treatments, and physicians can request access via expandedaccess@nrxpharma.com.
NRx Pharmaceuticals (NASDAQ:NRXP) reported Q2 2025 financial results and significant developments across its drug portfolio. The company received an expanded Fast Track Designation for NRX-100 from the FDA for all depression indications, increasing its addressable market to 13 million Americans. A $6.5 million investment was secured from B Group Capital for approximately 3.9 million shares with a one-year lockup.
Key developments include filing an ANDA for NRX-100, submitting an NDA for NRX-101, and expanding HOPE Therapeutics through strategic acquisitions. The company reported a Q2 2025 net loss of $17.6 million, compared to $7.9 million in Q2 2024, with $2.9 million in cash as of June 30, 2025. HOPE Therapeutics is targeting $100 million in pro-forma revenue by year-end 2025 through clinic acquisitions.
NRx Pharmaceuticals (NASDAQ:NRXP), a clinical-stage biopharmaceutical company, has rescheduled its second quarter 2025 financial results release to August 19, 2025 after market close. The company will host a conference call the following morning on August 20, 2025, at 8:00 AM ET.
The delay is due to the company requiring additional time to compile certain information and recent developments into their Form 10-Q filing. Investors can access the results via press release on the company's website and join the conference call through a webcast or by dialing +1-800-717-1738 (domestic) or +1-646-307-1865 (international).
NRx Pharmaceuticals (NASDAQ:NRXP), a clinical-stage biopharmaceutical company, will release its Q2 2025 financial results on August 14, 2025, after market close.
The company will host a conference call at 4:30 PM ET to discuss corporate updates, financial performance, recent regulatory events, and operational plans. Investors can access the call via webcast on the company's website or by dialing +1-800-717-1738 (domestic) or +1-646-307-1865 (international).
NRx Pharmaceuticals (NASDAQ:NRXP) has received FDA Fast Track designation for NRX-100, its intravenous ketamine treatment for suicidal ideation in patients with depression, including bipolar depression. This expanded designation represents a 10-fold increase in the addressable population compared to its 2017 designation.
Clinical trials demonstrated significant efficacy, with 55% response rate in suicidal patients compared to 30% for active comparator, and 63% achieving full remission from suicidal ideation within three days versus 31% for placebo. The company targets a $3+ billion market opportunity, addressing approximately 13 million Americans who consider suicide annually.
NRX-100 is the first preservative-free ketamine formulation filed with FDA, offering potential three-year room temperature shelf life. The company has completed CMC information filing and is pursuing a Commissioner's National Priority Voucher to expedite review.
NRx Pharmaceuticals (NASDAQ:NRXP) announced that its subsidiary HOPE Therapeutics has received final clearance from Florida's Agency for Health Care Administration (AHCA) to proceed with the acquisition of Dura Medical. Dura Medical, founded in 2018, is a revenue-generating and EBITDA-positive healthcare provider specializing in precision psychiatry services on Florida's west coast.
The acquisition, along with previously announced purchases of Neurospa TMS and Cohen and Associates, will expand HOPE's presence in Florida. Dura Medical provides advanced treatments including Ketamine Infusion Therapy, Transcranial Magnetic Stimulation (TMS), and Spravato® for depression, PTSD, and related disorders. The company aims to treat over 10,000 patients by 2026 and serves both civilian and veteran patients through the Veterans Affairs Community Cares Network.
NRx Pharmaceuticals (NASDAQ:NRXP) has filed a Citizen Petition with the FDA requesting the removal of Benzethonium Chloride (BZT) from all ketamine products sold in the United States. The company emphasizes that BZT is a toxic preservative not recognized as safe by the FDA for parenteral products or topical use.
In June 2025, NRx filed an Abbreviated New Drug Application for a preservative-free ketamine preparation, demonstrating 3-year room temperature stability. The company has established US-based manufacturing and is pursuing approval for ketamine use in treating suicidal depression through FDA's National Priority Voucher Program.
This initiative aligns with federal priorities to eliminate toxic additives from the US drug supply and promote domestic pharmaceutical manufacturing.
NRx Pharmaceuticals (NASDAQ: NRXP) announced its participation in the BTIG Virtual Biotechnology Conference. CEO and Chairman Prof. Jonathan Javitt will participate in a fireside chat alongside Prof. Samuel Wilkinson from Yale School of Medicine and BTIG Research Analyst Dr. Thomas Shrader.
The discussion, scheduled for July 30, 2025, at 8:00 a.m. EDT, will focus on neuroplasticity in the treatment of CNS disorders. Prof. Wilkinson brings expertise in ketamine and neuroplastic/psychedelic drugs for treating depression, suicidality, and PTSD.
NRx Pharmaceuticals (NASDAQ:NRXP) announced that its subsidiary, HOPE Therapeutics, has signed a binding Letter of Intent to acquire a 49% interest in Cohen and Associates, a premier interventional psychiatry clinic in western Florida.
Cohen and Associates, founded by Dr. Rebecca Cohen, will serve as a foundational clinic in the Sarasota-Bradenton region. The clinic specializes in treating suicidal depression, PTSD, and other CNS disorders through various treatments including ketamine, Spravato, and Transcranial Magnetic Stimulation (TMS). The acquisition is expected to be immediately accretive to revenue and EBITDA.