NRX Pharmaceuticals, Inc. is a clinical-stage small molecule pharmaceutical company. It engages in developing of novel therapeutics for the treatment of central nervous system disorders and life-threatening pulmonary diseases. The company was founded on September 18, 2017 and is headquartered in Wilmington, DE.
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- The FDA Office of Generic Drugs has reclassified an amendment to NRx Pharmaceuticals' ANDA for preservative-free ketamine from a Major Amendment to a Minor Amendment. - The acknowledgement letter revised the GDUFA goal date to November 10, 2026, citing that the reclassified amendment will not require substantial FDA resources. - NRx Pharmaceuticals is developing NRX-100, a preservative-free intravenous ketamine, which holds Fast Track Designation for suicidal ideation in depression, including bipolar depression. - The company has filed an ANDA and initiated an NDA filing for NRX-100, including an application for the Commissioner's National Priority Voucher Program.
- GeNeuro, Inc., a subsidiary of NRx Pharmaceuticals, has been awarded European Patent EP 3 570 878 B1 covering the anti-HERV K Envelope antibody GNK-301 for ALS. - The patent rests on the finding that the HERV K Envelope protein appears in the spinal fluid of more than 75% of people with ALS and is highly neurotoxic. - GNK-301 was developed with the US National Institute of Neurological Disorders and Stroke under a Cooperative Research and Development Agreement and is now in cGMP manufacture. - GeNeuro plans to begin Phase 1 trials of GNK-301 in ALS patients in the US and Europe in the second half of 2027, pending completion of grant submissions.
- NRx Pharmaceuticals has compelled arbitration with Kadima Neuropsychiatry Institute over Kadima's failure to meet key closing conditions, including delivery of clear title to assets and a material adverse change in the business. - Kadima and founder Dr. David Feifel filed suit in San Diego Superior Court alleging breach of contract and misrepresentation, seeking specific performance to compel NRx to close the acquisition. - NRx states that HOPE Therapeutics' scientific direction has evolved toward neuronavigated TMS with neuroplastic drugs like NRX-101, which the company claims is contrary to Dr. Feifel's approach. - NRx recently announced FDA clearance of an IND for the SPARC-TMS trial combining NRX-101 with robotic neuronavigated TMS, to begin at civilian and military treatment facilities in the fall.
- NRx Pharmaceuticals and neurocare Group AG announced a partnership to create a nationwide network of clinics offering integrated neuroplastic therapy for depression, PTSD, and other mental health disorders. - The partnership will leverage 400+ existing Apollo TMS devices and combine transcranial magnetic stimulation with ketamine therapy, hyperbaric oxygen, and psychotherapy to achieve high remission rates. - Recent scientific publications demonstrate that TMS integration with neuroplastic drugs achieved 87% response rates and 72% remission in treatment-resistant depression patients. - The partners aim to provide neuroplastic therapy within driving distance of any American home by the end of 2026, addressing CNS diseases affecting over 50 million Americans.
- NRx Pharmaceuticals has amended its Investigational New Drug filing for NRX-101 to include use with Transcranial Magnetic Stimulation (TMS) for treating depression, including suicidal depression. - Recent clinical studies show D-cycloserine combined with TMS achieved over 80% response rates compared to 30% success rates with SSRI antidepressants alone. - The company anticipates more than 1 million Americans per year may be treated with TMS by 2030, creating a substantial new market opportunity for NRX-101. - NRx plans to conduct well-controlled trials with approximately 120 participants and is in partnership discussions with TMS device manufacturers for joint clinical development.
- HOPE Therapeutics, a subsidiary of NRx Pharmaceuticals, received final clearance from Florida's Agency for Health Care Administration to proceed with the acquisition of Dura Medical LLC, a revenue-generating and EBITDA-positive precision psychiatry clinic network. - Dura Medical provides comprehensive interventional psychiatry services including ketamine infusion therapy, transcranial magnetic stimulation, and Spravato® for treating severe depression, PTSD, and related CNS disorders in both veteran and civilian populations. - The acquisition, combined with previously announced purchases of Neurospa TMS and Cohen and Associates, will establish HOPE's coverage along Florida's west coast and support Dura's mission to treat more than 10,000 patients by 2026. - The deal represents a strategic expansion for HOPE's network of interventional psychiatry clinics, with Dura Medical founder Stephen Durand pioneering the combination of psychedelic medications with neuroplastic technologies for treating suicidal depression and PTSD.
- NRx Pharmaceuticals and its subsidiary HOPE Therapeutics signed a definitive agreement to acquire Kadima Neuropsychiatry Institute, a leading interventional psychiatry clinic in La Jolla, California. - The acquisition positions Kadima as the clinical model for HOPE's planned nationwide network of 30 clinics by end of 2025, targeting $100 million in annual revenue. - Dr. David Feifel, Kadima's founder and nationally recognized expert in interventional psychiatry, will join HOPE as Chief Medical Innovation Officer upon closing. - The profitable clinic specializes in ketamine treatment, TMS, and other therapies for suicidal depression and PTSD, and has served as a leading investigative site for CNS and psychedelic research trials.
- NRx Pharmaceuticals is developing NRX-101, an FDA-designated Breakthrough Therapy for treatment-resistant bipolar depression with suicidality, with plans to file for Accelerated Approval. - The company has initiated a New Drug Application for NRX-100 (IV ketamine) for suicidal depression, supported by NIH clinical trials and recently acquired data from French health authorities. - Through its subsidiary HOPE Therapeutics, NRx is building a network of interventional psychiatry clinics to deliver ketamine, TMS, and other therapies alongside a digital platform to enhance NMDA-targeted treatments.
• The global bipolar depression market is projected to experience significant growth through 2034, driven by increasing prevalence, with the United States accounting for approximately 85% of the market share across major regions. • Several pharmaceutical companies including NeuroRx, COMPASS Pathways, and Intra-Cellular Therapies are advancing novel treatments, with Johnson & Johnson's recent $14.6 billion acquisition of Intra-Cellular Therapies highlighting industry confidence in the sector. • Among current therapies, CAPLYTA (lumateperone) is expected to achieve the highest market share by 2034, while emerging treatments like NRX-100/101 and COMP 360 (psilocybin) show promise for addressing unmet needs in bipolar depression management.
- NRx Pharmaceuticals subsidiary HOPE Therapeutics announces planned acquisition of Kadima Neuropsychiatry Institute to serve as the flagship for an international network of interventional psychiatry clinics treating depression and PTSD. - Dr. David Feifel, founder of Kadima and Professor Emeritus at UC San Diego, will join HOPE as Chief Medical Innovation Officer, bringing three decades of expertise in advanced interventional treatments for psychiatric disorders. - The acquisition aligns with HOPE's strategy to develop multi-modal treatment approaches combining ketamine therapy with transcranial magnetic stimulation and digital therapeutics, supported by $27 million in anticipated funding.
