PsychedelicNewsBreaks

MondaySep 29, 2025 10:10 am

PsychedelicNewsBreaks – NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) Re-files ANDA for Preservative-Free IV Ketamine KETAFREE(TM)

NRx Pharmaceuticals (NASDAQ: NRXP) announced it has re-filed its Abbreviated New Drug Application with the U.S. FDA for KETAFREE(TM), a preservative-free IV ketamine formulation, covering all existing approved indications, following FDA approval of its Suitability Petition. Targeting a ketamine market estimated at $750 million annually in the U.S. and projected to reach $3.35 billion globally by 2034, NRx is seeking priority review amid an ongoing drug shortage, citing its patented formulation manufactured with Nephron Pharmaceuticals in South Carolina as a safer alternative free of benzethonium chloride, a preservative linked to neurotoxicity. To view the full press release, visit https://ibn.fm/O5lcF About…

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WednesdaySep 24, 2025 11:15 am

PsychedelicNewsBreaks – NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) Receives FDA Approval of Suitability Petition for Preservative-Free Ketamine Product

NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, announced that the U.S. Food and Drug Administration has granted its Suitability Petition for KETAFREE(TM), a planned single-patient, preservative-free ketamine product. Unlike current ketamine offerings in multi-dose vials containing the toxic preservative Benzethonium Chloride, KETAFREE(TM) is designed to eliminate such additives. The approval enables immediate re-filing of the Company’s Abbreviated New Drug Application. NRx noted the product supports federal priorities of re-shoring sterile drug manufacturing and removing harmful preservatives, with the ketamine market estimated at $750 million. The Company is also advancing NRX-100, a non-generic ketamine formulation under development for suicidal depression…

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MondaySep 08, 2025 9:45 am

PsychedelicNewsBreaks – NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) Subsidiary HOPE Therapeutics Closes Acquisition of Dura Medical

NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, announced that its wholly owned subsidiary HOPE Therapeutics Inc. has closed the acquisition of Dura Medical, a revenue-generating and EBITDA-positive provider of interventional psychiatry services in Naples and Ft. Myers, Florida. Dura, founded in 2018, delivers treatments for depression, PTSD, suicidality, anxiety, and chronic pain through Ketamine Infusion Therapy, Transcranial Magnetic Stimulation, Spravato(R), Stellate Ganglion Blocks, and traditional psychiatry. The acquisition, along with pending deals for Neurospa TMS and Cohen and Associates, expands HOPE’s planned network to more than eight locations across Florida. Stephen Durand, Dura’s founder and a U.S. Army veteran,…

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WednesdaySep 03, 2025 1:10 pm

PsychedelicNewsBreaks – NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) to Join H.C. Wainwright’s 27th Annual Global Investment Conference; CEO Fireside Chat Set for Sept. 8, 2025, 4:30 to 5 p.m. ET

NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, and HOPE Therapeutics, Inc. (“HOPE”), an interventional psychiatry network wholly owned by NRx Pharmaceuticals, announced that Chairman and CEO Jonathan Javitt, M.D., M.P.H., will participate in a fireside chat at H.C. Wainwright’s 27th Annual Global Investment Conference on Monday, Sept. 8, 2025, from 4:30 to 5 p.m. ET. A webcast will be available on the Events page of the Investors section of the Company’s website, with a replay posted two hours after the event for 30 days. To view the full press release, visit https://ibn.fm/8fef5 About NRx Pharmaceuticals, Inc. NRx Pharmaceuticals, Inc.…

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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…

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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…

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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…

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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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