NRx targets 2026 KETAFREE approval and outlines SPARC-TMS trial in 400 patients backed by military funding

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NRx Pharmaceuticals said its preservative-free ketamine product KETAFREE now has only one remaining major FDA deficiency, tied to the Luer lock component of the vial, and the company aims for 2026 approval with 5 million units of launch stock already ordered. The company also said it was selected as a prime contractor by DARPA to lead the SPARC-TMS trial combining NRX-101 with robotic TMS, an FDA-approved Phase II/III study expected to include 240 patients in HOPE clinics and Harvard/McLean plus another 160 at military treatment facilities, all funded through the military while still in the contracting process. For the six months ended June 30, 2026, NRx reported a net loss of $18 million versus $23.1 million a year earlier, with cash and equivalents of $26.7 million as of June 30, 2026, up from $7.8 million at the end of 2025 after a public offering raised more than $22 million. Management also said NRX-100 is poised to finalize its NDA aiming for 2027 approval, and the GeNeuro asset GNK-301 is targeted for a first-in-human trial in July 2027 with development expected through nondilutive sources.

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NRx's GeNeuro asset GNK-301 is targeted for a first-in-human trial in July 2027, indicating progress in its pipeline.

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