NRx Pharmaceuticals has begun commercial-scale manufacturing of 5 million doses of preservative-free ketamine for potential commercialization in 2026, putting launch inventory into production while its abbreviated new drug application remains under FDA review.
The FDA completed its first-cycle review of the ANDA without identifying a major deficiency related to the drug itself or its manufacturing process. NRx said the remaining major item involved an attestation from the manufacturer regarding the vial’s luer-lock component. The requested attestation has been submitted to the agency.
NRx said the vial is manufactured in the same manner as components used for three other approved drugs that collectively ship more than 11.9 million units annually. With that response submitted, the company is targeting approval and commercialization during 2026.
The 5 million-unit launch inventory represents only the initial manufacturing plan. If commercialization begins, NRx anticipates subsequent manufacturing capacity of approximately 1 million units per month.
The company has also hired its first Chief Commercial Officer and retained a commercial launch team, meaning manufacturing, staffing and launch preparation are being advanced before the regulatory process is complete.
Separately, NRx is developing NRX-100 preservative-free ketamine through a New Drug Application for treating depression. The company is using real-world evidence involving more than 65,000 Americans and is targeting potential NDA approval in 2027.
NRx’s broader CNS pipeline also received potential non-dilutive support. DARPA selected the company as prime contractor for the SPARC-TMS Phase 2/3 program evaluating NRX-101 with robotic TMS, with anticipated non-dilutive funding of more than $11.5 million, subject to completion of contracting. The program could expand NRX-101 from a sub-one-million-patient suicidal bipolar depression population to a treatment-resistant depression market that NRx estimates at more than 15 million Americans.
The company raised $22.3 million through an underwritten public offering and ended June with approximately $26.7 million of cash, up from $7.8 million at the end of 2025. NRx expects its existing cash to support at least one year of operations.
For the first six months of 2026, net loss narrowed to $18 million from $23.1 million, although operating loss increased to $11.3 million from $7.6 million as the company spent more on acquired R&D assets and preparations for a potential ketamine launch.
KEY QUOTES:
“The second quarter of 2026 was a major inflection point for NRx as we advance our mission to bring hope to the most vulnerable patients battling depression and suicidal ideation. We have continued to drive towards our key objective of first commercial ketamine sales in 2026 with corresponding manufacturing operations and build-out of our first commercial team. Our path to approval of NRX-100 has been advanced by support from the White House and Congress for the use of Real World Evidence that our drug has comparable or superior efficacy to that of current market leaders. Our partnership with the Department of War and its Defense Advanced Research Projects Agency led by Prof. Brown and Dr. Dennis McBride is the culmination of a multi-year endeavor. Similarly, our acquisition of the GeNeuro assets and the resulting partnership with NIH offers a clinical stage and potentially humanity-changing opportunity for the Company – including potentially the first disease-modifying drug to treat ALS – in ALS and other serious disorders, with strong governmental partnership and support from non-dilutive sources of capital. Combat veterans face a two-fold increased risk of ALS, and advancing a cure remains a high priority with strong Congressional support.”
Dr. Jonathan Javitt, CEO and Chairman of NRx Pharmaceuticals
