PsychedelicNewsBreaks Archive - Page 2 of 69

TuesdaySep 02, 2025 2:52 pm

PsychedelicNewsBreaks – NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) Showcases HOPE Therapeutics at Global Passion Project Event

NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, presented two keynote talks at the Global Passion Project and Rockefeller Capital symposium held Aug. 28–30, 2025, in Southampton, N.Y. CEO Prof. Jonathan Javitt, MD, MPH, outlined plans for the Fall 2025 launch of HOPE Therapeutics clinics and a one-week residential program targeting suicidal depression, PTSD, traumatic brain injury and cognitive dysfunction. The program will be the first in the U.S. to combine neuroplastic drugs such as ketamine with transcranial magnetic stimulation, hyperbaric oxygen therapy, nutritional therapy, outdoor activities and supportive therapy in a comprehensive setting. At the event, Matthew Rockefeller was…

WednesdayAug 27, 2025 11:20 am

PsychedelicNewsBreaks – NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) Announces Expanded Access Policy for NRX-100 Following FDA Fast Track Designation

NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, announced its expanded access policy for NRX-100 (preservative-free ketamine) after receiving FDA Fast Track designation for the treatment of suicidal ideation in patients with depression, including bipolar depression. The designation reflects FDA’s determination that NRX-100 may address an unmet need based on preliminary data. Eligible patients may access the investigational therapy under specific conditions, including lack of response or tolerance to approved treatments and sufficient supporting clinical data. Chairman and CEO Dr. Jonathan C. Javitt said the company is committed to making NRX-100 available to patients with suicidal depression who have limited…

MondayAug 18, 2025 10:40 am

PsychedelicNewsBreaks – NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) Reports Q2 2025 Results, Highlights Progress Across Lead Programs and Strategic Investment

NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, reported financial results for the quarter ended June 30, 2025, and provided a corporate update. The Company highlighted progress in all three lead programs, including expanded FDA Fast Track designation for NRX-100 in treating suicidal depression, filing of multiple regulatory documents, and advancement of the NRX-101 NDA. A strategic investor group led by B Group Capital has committed capital through a purchase of restricted common stock with a one-year lockup and no dilutive mechanisms. The capital is expected to support the Company through key regulatory milestones and help scale HOPE Therapeutics and…

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…

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…

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…

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…

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…

WednesdayJul 16, 2025 11:49 am

PsychedelicNewsBreaks – NRx Pharmaceuticals Inc. (NASDAQ: NRXP) Positioning at the Forefront of Next-Gen Treatment

NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, is executing a dual growth strategy focused on expanding its national network of mental health clinics through its subsidiary, HOPE Therapeutics, and advancing its proprietary NMDA-based therapies toward FDA approval. HOPE recently announced plans to deploy $10.3 million in total acquisition capital to purchase clinics that provide interventional psychiatric care focused on neuroplastic therapies like transcranial magnetic stimulation (“TMS”) and ketamine. The clinics are projected to generate $15 million in 2025 revenue, with additional acquisitions in discussion that could add another $20 million. At the same time, NRx is progressing NRX-100, a…

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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