NRx Pharmaceuticals Inc. NRXP Archives

ThursdayOct 16, 2025 2:36 pm

QualityStocksNewsBreaks – NRx Pharmaceuticals Inc. (NASDAQ: NRXP) Advances KETAFREE(TM), Expands Pipeline Targeting Urgent Needs

NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, recently secured approval from the U.S. Food and Drug Administration (“FDA”) for its Suitability Petition to advance KETAFREE(TM), a preservative-free version of ketamine. “The ruling allows the company to re-file its Abbreviated New Drug Application (‘ANDA’) for the product, which it has now done, a key step in bringing it to market,” reads a recent article. “Currently, ketamine is sold in multidose vials that require preservatives to maintain sterility after repeated use. The most common additive, Benzethonium Chloride, is known to be toxic. NRx’s proposed alternative eliminates preservatives by using single-patient dosing,…

ThursdayOct 16, 2025 9:45 am

NRx Pharmaceuticals Inc. (NASDAQ: NRXP) Pursues Dual Pathway for Preservative-Free Ketamine-Based Therapies

The company has refiled its Abbreviated New Drug Application (“ANDA”) for KETAFREE(TM), a preservative-free IV ketamine formulation. The filing follows FDA approval of the company’s Suitability Petition to remove benzethonium chloride (“BZT”), a preservative linked to neurotoxicity. In parallel, NRx is advancing NRX-100, another preservative-free ketamine formulation under a New Drug Application (“NDA”) for suicidal ideation in depression, including bipolar depression. NRX-100 holds Fast Track Designation and may qualify for the FDA’s National Priority Voucher Program. The company also continues work on NRX-101, a Breakthrough Therapy for suicidal bipolar depression. CEO Dr. Jonathan Javitt recently discussed new pipeline developments and…

WednesdayOct 08, 2025 2:08 pm

QualityStocksNewsBreaks – NRx Pharmaceuticals Inc. (NASDAQ: NRXP) Strengthens Pipeline with Dual Pathways for Ketamine-Based Therapies

NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, has re-filed an Abbreviated New Drug Application (“ANDA”) for KETAFREE(TM), a preservative-free intravenous (“IV”) ketamine formulation intended for all currently approved ketamine indications. This follows FDA approval of NRx’s Suitability Petition… KETAFREE(TM) is designed to eliminate benzethonium chloride (“BZT”), a known neurotoxic and cytotoxic preservative still present in many ketamine formulations. NRx previously submitted a Citizen Petition urging the FDA to ban BZT from all IV ketamine products, citing long-term health risks and filing supporting toxicology evidence… In parallel, NRx is advancing NRX-100, a separate preservative-free ketamine formulation, under a New Drug Application…

TuesdayOct 07, 2025 9:00 am

NRx Pharmaceuticals Inc. (NASDAQ: NRXP) Gains FDA Nod for Preservative-Free Ketamine Suitability Petition

FDA grants NRx Pharmaceuticals approval of a Suitability Petition for single-patient preservative-free ketamine. The decision enables re-filing of an Abbreviated New Drug Application (“ANDA”) for the company’s KETAFREE(TM) product, which the company has now done. Current ketamine formulations use multidose vials with a toxic preservative, Benzethonium Chloride. U.S. ketamine market is estimated at $750 million annually, presenting a significant commercial opportunity. NRx is also advancing NRX-100 and NRX-101 for suicidal depression and PTSD, both with FDA designations. The move aligns with U.S. policy goals on reshoring drug production and reducing toxic additives. NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company,…

MondaySep 29, 2025 10:10 am

QualityStocksNewsBreaks – 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…

MondaySep 08, 2025 9:45 am

QualityStocksNewsBreaks – 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,…

WednesdaySep 03, 2025 1:10 pm

QualityStocksNewsBreaks – 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/dqui5 About NRx Pharmaceuticals, Inc. NRx Pharmaceuticals, Inc.…

TuesdaySep 02, 2025 9:00 am

NRx Pharmaceuticals Inc. (NASDAQ: NRXP) Secures FDA Fast Track for IV Ketamine Formulation NRX-100 in Suicidal Depression

The FDA designation expands the drug’s potential patient pool tenfold, to an estimated 13 million Americans who consider suicide annually. Clinical trials demonstrated rapid and statistically significant reductions in suicidal ideation with IV ketamine versus placebo and comparators. Fast Track status makes NRX-100 eligible for Accelerated Approval and the Commissioner's National Priority Voucher program. NRx is preparing an expanded access policy and seeking meetings with FDA leadership to align on data submission. The U.S. suicidal depression market is estimated at more than $3 billion annually. NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, announced that the U.S. Food and Drug…

FridayAug 22, 2025 12:00 pm

NRx Pharmaceuticals Inc. (NASDAQ: NRXP) Seeks FDA Ban on Toxic Ketamine Preservative

NRx Pharmaceuticals has filed a Citizen Petition with the FDA to remove benzethonium chloride from ketamine products. The preservative has known toxicity and is no longer allowed in hand sanitizers or topical antiseptics. Ketamine is increasingly used off-label for treating suicidal depression and PTSD. The company argues repeated exposure to benzethonium chloride through IV use poses unnecessary health risks. NRx has submitted data showing its preservative-free ketamine maintains sterility and stability for three years. The company is pursuing FDA approval for both its preservative-free ketamine (“NRX-100”) and oral NMDA-targeting drug (“NRX-101”). NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, has…

MondayAug 18, 2025 10:40 am

QualityStocksNewsBreaks – 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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