NRx Pharmaceuticals Begins 1M-Dose Monthly Ketamine Production, Eyes Q3 2026 FDA Decision
NRXP•NRx expects an FDA decision on its preservative-free ketamine ANDA in Q3 2026 after favorable bioequivalence and manufacturing determinations, and has begun one-million-dose monthly production to address a $750 million market shortage. It also secured IND clearance for NRX-101 as a robotic TMS adjunct with federal funding.
1. Preservative-Free Ketamine ANDA and Commercial Manufacturing
NRx advanced its KETAFREE™ ANDA through FDA Office of Generic Drugs review with no major deficiencies and achieved VAI manufacturing status, enabling one-million-dose batch production. The company has initiated commercial manufacturing to address ongoing national ketamine shortages in a generic market estimated at $750 million annually.
2. NRX-101 IND Clearance and TMS Trial
The FDA accepted an IND application for NRX-101 as an adjunct to robotic-enabled Transcranial Magnetic Stimulation, unlocking non-dilutive federal funding for trials at military and civilian sites. NRx is preparing a Phase 2b/3 MIND1 study enrolling 400 participants across multiple facilities under an accelerated one-day TMS protocol.
3. Interventional Psychiatry Clinics Revenue
NRx generated its first revenue from five HOPE Therapeutics clinics treating severe depression and PTSD, funded by the VA, Department of Defense and private insurers. Management expects the clinic network to expand to eight or more locations by mid-2026, bolstering real-world evidence for its pipeline.
4. Geneuro SA Acquisition and Pipeline Expansion
Through a Swiss court-supervised liquidation, NRx is acquiring Geneuro SA’s assets, including a patent portfolio, monoclonal antibodies, cell lines and Phase 2 data targeting HERVs implicated in schizophrenia, ALS, MS, autism and Type 1 diabetes, significantly broadening its therapeutic pipeline.
