NRx Pharmaceuticals (Nasdaq: NRXP) is a clinical-stage biopharmaceutical company developing NRX-100 (preservative-free IV ketamine) and NRX-101 (an oral D-cycloserine/lurasidone combination) for suicidal depression and bipolar depression. NRX-100 holds FDA Fast Track designation and NRX-101 holds Breakthrough Therapy designation. Through 2025 and 2026 the company advanced a regulatory path for its ketamine product, marketed as KETAFREE, with an FDA-accepted ANDA carrying a mid-2026 review goal date.
NRx Pharmaceuticals News 9 articles
- FDA accepts NRx's ANDA for preservative-free IV ketamine KETAFREE with July 2026 goal date
- FDA approves NRx suitability petition for preservative-free ketamine strength
- FDA grants NRx expanded Fast Track for NRX-100 (IV ketamine) in suicidal depression
- HOPE Therapeutics, Inc. and NRx Pharmaceuticals, Inc. Execute Agreement for $27 Million Funding Transaction for HOPE Clinic Acquisition
- Hope Therapeutics, Inc. and NRx Pharmaceuticals, Inc. Announce Kadima Neuropsychiatry Institute as the Expected First Acquisition for its International Network of Interventional Psychiatry Clinics
- NRx Pharma Subsidiary HOPE Therapeutics Secures $30M to Buy Ketamine Clinics
- NRx Pharmaceuticals Announces the Licensure of a US Patent to Support Use of NRX-101™ for Chronic Pain
- NRx Pharmaceuticals Announces Positive Recommendation to Continue Enrollment in the Ongoing Trial of NRX-101 in Patients with Suicidal Treatment-Resistant Bipolar Depression
- NRx Pharmaceuticals Provides Business Update and Reports Second Quarter 2022 Results Focusing on Reactivation & Advancement of its Psychiatry Franchise