NRX Pharmaceuticals (NRXP) Stock News, May-Aug 2025

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.

NRx Pharmaceuticals (NASDAQ:NRXP) has filed for the FDA's new Commissioner's National Priority Voucher (CNPV) program for NRX-100, its preservative-free ketamine formulation. The CNPV program could reduce FDA review time from 10-12 months to 1-2 months. The company's application aligns with all required criteria, including addressing the US health crisis of suicidal depression and PTSD. NRx has already submitted CMC information and received FDA feedback, maintaining its timeline for potential approval by end of 2025. The company is targeting the current $750 million ketamine market, projected to reach $3-5 billion by 2033. NRx is also filing a citizen petition to withdraw preservative-containing ketamine forms and has filed a patent for its preservative-free manufacturing process.

NRx Pharmaceuticals (NASDAQ: NRXP) and its subsidiary HOPE Therapeutics announced a strategic investor relations partnership with astr partners, a boutique IR firm specializing in life sciences. The partnership comes at a crucial time as NRx has filed an ANDA and is approaching completion of two NDA filings, while actively acquiring profitable interventional psychiatry clinics. astr partners, founded by former The Trout Group veterans Jonathan Fassberg and Brian Korb, will provide comprehensive IR services including investor targeting, message development, earnings preparation, and investor engagement. The firm brings extensive experience in biotech investor relations and healthcare capital markets, having previously held senior positions at Solebury Trout and Oppenheimer & Co.

NRx Pharmaceuticals (NASDAQ:NRXP), a clinical-stage biopharmaceutical company, along with its subsidiary HOPE Therapeutics, announced their participation in the H.C. Wainwright 6th Annual Neuro Perspectives Hybrid Conference on June 16-17, 2025. Dr. Jonathan Javitt, Founder, Chairman and CEO of NRx and Co-CEO of HOPE, will deliver a corporate presentation highlighting the company's recent developments. The presentation will be available on-demand to registered attendees starting June 16, 2025, at 7:00 a.m. ET. The company will also conduct one-on-one meetings with investors throughout the conference.

NRx Pharmaceuticals has submitted an Abbreviated New Drug Application (ANDA) to the FDA for NRX-100, a preservative-free IV ketamine formulation. The company aims to address the current US ketamine shortage in a market valued at $750 million, projected to reach $3.35 billion globally by 2034. NRX-100 eliminates benzethonium chloride, a neurotoxic preservative, and will be marketed for all approved uses including anesthesia and pain management. The company plans to file a citizen's petition to remove this toxic preservative from all IV ketamine products. This ANDA complements NRx's ongoing NDA submission for ketamine use in suicidal depression, with PDUFA anticipated in late 2025. The product has received Fast Track Designation and a PDUFA fee waiver, with patent protection sought through 2045.

NRx Pharmaceuticals (NASDAQ:NRXP), a clinical-stage biopharmaceutical company, announced its selection to present at the Wall Street Conference on May 21, 2025 in Palm Beach, Florida. Dr. Jonathan Javitt, Founder, Chairman and CEO of NRx and Co-CEO of HOPE Therapeutics, will provide a company update focusing on progress towards FDA approval of NRX-100 (preservative-free ketamine) and upcoming acquisitions of HOPE clinics specializing in treatment of suicidal depression, PTSD, and related disorders.

The conference, which will host six presenting companies, is expected to attract over 1,000 attendees representing more than $1 trillion in investment capital.

NRx Pharmaceuticals (NASDAQ:NRXP) reported Q1 2025 financial results and provided significant updates on its drug development pipeline. The company is advancing two key drugs: NRX-100 (preservative-free IV ketamine) and NRX-101 for suicidal depression, with NDAs expected in 2025. Notable achievements include a $4.3M FDA fee waiver for NRX-100 and a new patent filing potentially providing exclusivity until 2045. Through its HOPE Therapeutics subsidiary, NRXP is expanding into clinical operations with planned acquisitions of three clinics representing ~$15M in pro-forma revenues, with additional targets identified for ~$20M more. The company raised $8.9M in January 2025 and secured $10.3M in non-dilutive acquisition capital. Q1 2025 showed improved financials with net loss of $5.5M versus $6.5M in Q1 2024. Cash position stands at $5.5M, expected to support operations through 2025.