NRx reports Q2 2026 results, advances ketamine ANDA and DARPA-backed NRX-101 trial

NRx Pharmaceuticals reported second quarter 2026 results and a corporate update on August 17, 2026. The company said it completed first-cycle FDA review of its ANDA for preservative-free ketamine with no drug-related major deficiencies.¹ FDA identified a single major deficiency tied to the luer lock component of the vial, requesting a manufacturer's attestation that the vial is made the same way as three other approved drugs shipping more than 11.9 million units a year.¹ NRx said it has since submitted that attestation and is targeting 2026 approval and commercialization.¹ The company has five million units of launch stock in production, with planned post-launch manufacturing of one million units per month.¹

NRx also continues to pursue a separate New Drug Application for NRX-100, the same preservative-free ketamine, citing a Presidential Executive Order and Congressional budget language directing FDA to consider real-world evidence, and it now expects to finalize that NDA with a target approval in 2027.¹

On the pipeline side, NRx said the Defense Advanced Research Projects Agency named it prime contractor for a study called "SPARC-TMS," an FDA-approved Phase 2/3 trial of NRX-101 combined with robotic TMS¹, with anticipated non-dilutive funding exceeding $11.5 million, subject to completion of contracting.¹ The trial is registered at clinicaltrials.gov under NCT 07227103 and will assess NRX-101 alongside robotic-assisted TMS.¹

On financing, NRx closed a public offering of common stock underwritten with institutional support, raising gross proceeds of $22.3 million including full exercise of the underwriters' option.¹ As of June 30, 2026, the company held about $26.7 million in cash and equivalents, up from $7.8 million at the end of 2025.¹ Management said it believes current cash, expected clinic revenue growth, and use of its at-the-market facility will support operations for at least one year.¹