Breaks Categories: News

MondayAug 11, 2025 10:59 am

PsychedelicNewsBreaks – NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) Receives FDA Fast Track Designation for NRX-100 in Treating Suicidal Ideation in Depression 

NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to NRX-100 for treating suicidal ideation in patients with depression, including bipolar depression—a 10-fold expansion from its prior 2017 designation for use with NRX-101 in suicidal bipolar depression. The FDA’s determination, based on preliminary data, also supports potential eligibility for the Commissioner’s National Priority Voucher Program and the Accelerated Approval Program. Controlled trials licensed by NRx showed NRX-100 (IV ketamine) reduced suicidal ideation significantly, with one Columbia University study reporting a 55% response rate versus 30% for active comparator…

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FridayAug 08, 2025 10:55 am

PsychedelicNewsBreaks – NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) Subsidiary HOPE Therapeutics(TM) Secures Florida Regulatory Clearance to Close Dura Medical Acquisition

NRx Pharmaceuticals (NASDAQ: NRXP), through its wholly owned subsidiary HOPE Therapeutics(TM), Inc., announced it has received final clearance from the Florida Agency for Health Care Administration to proceed with closing its acquisition of revenue-generating, EBITDA-positive Dura Medical LLC, pending customary conditions. Founded in 2018, Dura operates clinics on Florida’s west coast specializing in mental health and chronic pain treatment, offering Ketamine Infusion Therapy, Transcranial Magnetic Stimulation (TMS), Spravato(R), Stellate Ganglion Blocks, and Traumatic Incident Reduction Therapy. The company also serves veterans through the Veterans Affairs Community Cares Network. HOPE leaders said the acquisition will expand its Florida network and integrate…

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MondayAug 04, 2025 9:34 am

PsychedelicNewsBreaks – NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) Petitions FDA to Ban Benzethonium Chloride from Ketamine Products

NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, has filed a Citizen Petition with the FDA requesting the removal of Benzethonium Chloride (BZT) from all ketamine products sold in the U.S. BZT, a quaternary amine preservative, is not Generally Recognized as Safe (GRAS) for parenteral use or Generally Recognized as Safe and Effective (GRASE) for topical use, and has demonstrated toxicity to epithelial cells and nerves. NRx previously submitted an Abbreviated New Drug Application for a preservative-free ketamine formulation with three-year room temperature stability and sterility, supported by a newly filed patent. The company is also pursuing a labeled indication…

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TuesdayJul 29, 2025 11:55 am

PsychedelicNewsBreaks – NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) CEO to Join Fireside Chat at BTIG Virtual Biotechnology Conference

NRx Pharmaceuticals (NASDAQ: NRXP), announced that CEO and Chairman Prof. Jonathan Javitt, MD, MPH will participate in a fireside chat at the BTIG Virtual Biotechnology Conference on July 29–30, 2025. The discussion, scheduled for 8:00 a.m. EDT on July 30, will feature Prof. Samuel Wilkinson, MD, of Yale School of Medicine, and BTIG Research Analyst Dr. Thomas Shrader. The session will focus on neuroplasticity in treating CNS disorders, including the use of ketamine and other neuroplastic and psychedelic drugs for depression, suicidality, and PTSD. To view the full press release, visit https://ibn.fm/lzwtG About NRx Pharmaceuticals, Inc. NRx Pharmaceuticals is a…

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FridayJul 18, 2025 3:00 pm

PsychedelicNewsBreaks – NRx Pharmaceuticals Inc. (NASDAQ: NRXP) Charts Dual-Path for NRX-100 

NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company developing innovative treatments for suicidal depression and PTSD, is accelerating its push toward regulatory approval of NRX-100, a preservative-free intravenous ketamine formulation. “The company recently filed an application under the newly created FDA Commissioner’s National Priority Voucher (‘CNPV’) program, which promises significantly shortened review timelines for drugs that meet urgent U.S. health priorities,” reads an article discussing NRx. “In parallel, the company has filed an Abbreviated New Drug Application (‘ANDA’) for NRX-100 with a request for priority review. The two pathways, CNPV and ANDA, are expected to complement one another. Should the…

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ThursdayJun 26, 2025 11:43 am

PsychedelicNewsBreaks – NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) Subsidiary HOPE Therapeutics to Acquire 49% Stake in Leading Florida Psychiatry Clinic

NRx Pharmaceuticals (NASDAQ: NRXP), via its wholly owned subsidiary HOPE Therapeutics(TM), Inc., has signed a binding Letter of Intent to acquire a 49% interest in Cohen and Associates, LLC, a top interventional psychiatry clinic founded by Dr. Rebecca Cohen in the Sarasota-Bradenton region. The clinic offers advanced treatments for suicidal depression, PTSD, and CNS disorders, including ketamine, Spravato, and TMS. The deal aims to establish a foundational clinic for HOPE’s regional growth and reflects its mission to deliver compassionate, evidence-based mental health care. Final terms remain subject to closing and definitive agreements. To view the full press release, visit https://ibn.fm/18OXc…

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TuesdayJun 24, 2025 9:10 am

PsychedelicNewsBreaks – NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) Taps IBN to Lead Corporate Communications Amid Drug Advancements and Subsidiary Launch

NRx Pharmaceuticals (NASDAQ: NRXP) a clinical-stage biopharmaceutical company developing innovative treatments for suicidal depression and PTSD, has engaged IBN to manage its corporate communications strategy. NRx is advancing two FDA-designated therapies—NRX-100 and NRX-101—with an NDA underway for NRX-100 and additional regulatory filings in progress. The company also launched HOPE Therapeutics, a subsidiary focused on building a national psychiatric care network, with plans for a public spin-out. IBN will leverage its extensive media portfolio to expand investor awareness and outreach. To view the full press release, visit https://ibn.fm/AW7z3 About NRx Pharmaceuticals, Inc. NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics…

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MondayJun 23, 2025 9:20 am

PsychedelicNewsBreaks – NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) Applies for FDA Commissioner’s Priority Voucher for NRX-100 Ketamine Formulation

NRx Pharmaceuticals (NASDAQ: NRXP) has filed for the newly launched FDA Commissioner’s National Priority Voucher (CNPV) program, seeking accelerated review for NRX-100, its preservative-free intravenous ketamine formulation. The company believes NRX-100 meets all criteria outlined by FDA Commissioner Marty Makary, who announced the voucher program on June 17, 2025, to prioritize treatments aligned with urgent U.S. health needs—including suicidal depression and PTSD. NRx has already submitted the chemistry, manufacturing, and controls (CMC) portion of its application and received FDA feedback, placing it on track for potential accelerated review of its full New Drug Application (NDA) by late 2025. If granted,…

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WednesdayJun 18, 2025 11:39 am

PsychedelicNewsBreaks – Psyence Biomedical Ltd. (NASDAQ: PBM) to Present at Psychedelic Science 2025

Psyence Biomed (NASDAQ: PBM) has announced that its Chief of Global Impact, Mary-Elizabeth Gifford, was selected as a featured speaker at Psychedelic Science 2025 (“PS2025”) – the world's largest international gathering focused on psychedelic research, biopharma, medicine, policy, and culture. Hosted by the Multidisciplinary Association for Psychedelic Studies (“MAPS”), the highly anticipated conference is taking place June 16-20, 2025, in Denver, Colorado. Psyence BioMed will present on business ethics in a panel session, “We are the Guardrails: Profit with Purpose.” In the role of Chief of Global Impact for Psyence Biomed, the first Nasdaq-listed biopharma with a focus on developing…

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MondayJun 16, 2025 9:20 am

PsychedelicNewsBreaks – NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) Forms Investor Relations Partnership With astr Partners

NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, and its subsidiary HOPE Therapeutics announced a strategic investor relations partnership with astr partners, a boutique firm specializing in life sciences. The collaboration comes as NRx advances toward two NDA filings, an ANDA submission, and expands its interventional psychiatry clinic acquisitions. Led by veterans of The Trout Group, astr will support NRx and HOPE with investor targeting, message development, earnings prep, and institutional outreach to enhance visibility and engagement. To view the full press release, visit https://ibn.fm/Frllm About NRx Pharmaceuticals, Inc. NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on…

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