NewsRoom Articles - PsychedelicNewsWire (PNW)

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…

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,…

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…

TuesdayJul 08, 2025 9:00 am

NRx Pharmaceuticals Inc. (NASDAQ: NRXP) Subsidiary to Acquire 49% Stake in Prominent Florida Neuropsychiatry Clinic

The acquisition of Cohen and Associates, a respected interventional psychiatry practice, by NRx subsidiary HOPE Therapeutics, is expected to be immediately accretive to revenue and EBITDA. Cohen, serving the Sarasota-Bradenton area in Florida, specializes in treatments, including ketamine and TMS, for mood disorders, PTSD, and suicidal depression. HOPE Therapeutics is expanding toward a target of 30 clinics with a $100 million run rate by the end of 2025. NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, and its wholly-owned subsidiary HOPE Therapeutics, Inc., a multi-site clinical care delivery organization, recently signed a binding letter of intent to acquire a 49%…

FridayJun 27, 2025 9:45 am

NRx Pharmaceuticals Inc. (NASDAQ: NRXP) Applies for FDA Commissioner’s National Priority Voucher for IV Ketamine NRX-100

The new FDA voucher program aims to speed approval of drugs aligned with national health priorities. NRX-100, a preservative-free ketamine, is also under an Abbreviated New Drug Application (“ANDA”) with a priority review request. NRx has submitted full CMC data and draft labeling for NRX-100, meeting key Commissioner’s National Priority Voucher pre-qualification criteria. The company’s U.S.-based manufacturing aims to reduce foreign supply chain dependence and address diversion concerns. A patent on the preservative-free process and a citizen petition to withdraw preserved ketamine could bolster NRx’s market position. NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company developing innovative treatments for suicidal depression and…

ThursdayJun 12, 2025 9:00 am

NRx Pharmaceuticals Inc. (NASDAQ: NRXP) Files Abbreviated New Drug Application for Preservative-Free IV Ketamine NRX-100 Amid Ongoing Shortage

The company targets all current ketamine indications, including anesthesia and pain management. The U.S. is facing a severe ketamine shortage, prompting NRx to seek priority FDA review. NRX-100 eliminates benzethonium chloride, aligning with U.S. health initiatives to remove toxic preservatives. The company plans to petition the FDA to remove benzethonium chloride from all intravenous ketamine products. The filing complements the company’s NDA for NRX-100 for suicidal depression, with a PDUFA date expected in late 2025. NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, has filed an Abbreviated New Drug Application with the U.S. Food and Drug Administration for NRX-100, a preservative-free formulation…

ThursdayJun 05, 2025 11:15 am

NRx Pharmaceuticals Inc. (NASDAQ: NRXP) Signs Agreement to Acquire Kadima to Launch $100M Psychiatry Clinic Network

The Kadima Neuropsychiatry Institute acquisition is part of NRx subsidiary HOPE Therapeutics’ model for a planned national clinic network, and is expected to immediately improve revenue and EBITDA for NRx and HOPE Therapeutics. HOPE aims to develop a network of up to 30 interventional psychiatry clinics by the end of 2025, with a $100 million pro forma run rate by YE 25. Kadima specializes in interventional psychiatry, and Kadima’s founder Dr. David Feifel, will join HOPE as Chief Medical Innovation Officer. NRx’s broader pipeline includes FDA-designated treatments for bipolar depression and acute suicidality. NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical…

WednesdayMay 28, 2025 9:45 am

NRx Pharmaceuticals Inc. (NASDAQ: NRXP) Announces $10.3 Million Financing to Expand HOPE Clinic Network, Advances FDA Drug Approval

Subsidiary HOPE Therapeutics signed a $7.8 million debt financing term sheet with Universal Capital. Combined with a prior strategic investment, for which a financing term sheet has also been signed, the total financing investment, assuming both are closed, represents an expected $10.3 million for HOPE acquisition funding, supporting initial acquisitions of Dura Medical, Kadima, and NeuroSpa clinics. The expanding HOPE clinic network will deliver neuroplastic therapies for depression and PTSD, including ketamine and TMS. NRx continues regulatory progress for NRX-100 (IV ketamine) and NRX-101 (oral bipolar depression therapy). The FDA waived NRx’s $4.3 million drug application fee, and patents could…

FridayMay 23, 2025 10:30 am

NRx Pharmaceuticals Inc. (NASDAQ: NRXP) Subsidiary, HOPE Therapeutics, to Expand Interventional Psychiatry Treatment with Kadima Institute Acquisition

Kadima Neuropsychiatry Institute is expected to become the clinical model for HOPE Therapeutics’ nationwide network of psychiatric clinics. The acquisition brings profitability and is expected to be accretive to both revenue and EBITDA. Kadima’s founder and medical director, Dr. David Feifel, a leader in interventional psychiatry, will join HOPE as Chief Medical Innovation Officer. NRx’s pipeline includes investigational drugs for suicidal bipolar depression and chronic pain. HOPE is targeting 30 clinic acquisitions by the end of 2025, projecting $100M in annual revenue. NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, and its wholly owned subsidiary HOPE Therapeutics, Inc., a medical…

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