Core Viewpoint - NRx Pharmaceuticals has received acknowledgment from the FDA for its Abbreviated New Drug Application (ANDA) for KETAFREE™, a preservative-free intravenous ketamine formulation, with a goal date for final review set for July 29, 2026 [1][8]. Company Developments - The FDA has determined that the ANDA for KETAFREE™ is "substantially complete," marking a significant milestone for the company [1][8]. - KETAFREE™ aims to provide a single-patient, preservative-free ketamine option, addressing safety concerns associated with the current multi-dose vials containing Benzethonium Chloride (BZT), which is not recognized as safe by the FDA [2][3]. - The company has manufactured initial registration lots of KETAFREE™ and is prepared to scale production to 1 million vials per month [8]. Market Context - The global generic ketamine market is estimated to be worth $750 million annually, indicating a substantial market opportunity for KETAFREE™ upon approval [8]. - The current healthcare initiatives are focused on the review and removal of toxic substances from drugs, aligning KETAFREE™ with these priorities [4]. Future Outlook - The next key milestone for NRx Pharmaceuticals is the completion of the FDA review under the Generic Drug User Fee Amendments framework, with the GDUFA goal date also set for July 29, 2026 [5][8]. - The company is also advancing its pipeline, including the development of NRX-100 for suicidal depression, which has received Fast Track designation from the FDA [5][7].

Core Points - NRx Pharmaceuticals, Inc. will present at NobleCon21 on December 3rd, 2025, focusing on its expanded initiatives in investigational drugs and therapies for mental health conditions [1][2] - The company has begun generating clinical revenue and has made significant advancements in drug development since its last appearance at NobleCon in 2024 [2] Company Overview - NRx Pharmaceuticals is a clinical-stage biopharmaceutical company specializing in Neuroplastic Therapies for central nervous system disorders, including suicidal depression, PTSD, anxiety, and Autism [5] - The company is developing NRX-100 (preservative-free intravenous ketamine) and NRX-101 (oral D-cycloserine/lurasidone), with NRX-100 receiving Fast Track Designation for treating suicidal ideation in depression and NRX-101 receiving Breakthrough Therapy Designation for suicidal bipolar depression [5] - NRx has filed an Abbreviated New Drug Application for its ketamine formulation, anticipating a launch in July 2026 [5] HOPE Therapeutics Overview - HOPE Therapeutics, a subsidiary of NRx, is establishing a network of interventional psychiatry clinics offering various therapies, including ketamine and transcranial magnetic stimulation [6] - The network is the first in Florida to provide the AMPA One Day (ONE-D) treatment, which combines TMS, physician-prescribed D-cycloserine, and lisdexamfetamine for treatment-resistant depression [6] Conference Details - Interested investors can attend the presentation at a discounted rate using a specific discount code [3] - A high-definition video webcast of the presentation will be available on the company's website and other platforms for 90 days following the event [4]