KETAFREE

Aug. 17, 2026: NRx Pharmaceuticals (NASDAQ: NRXP) reported multiple catalyst updates. Preservative-free ketamine/NRX-100: the company said FDA completed first-cycle review of its ANDA with no major drug- or manufacturing-related deficiencies; the only remaining issue was a manufacturer attestation for the vial/luer-lock component, which has been submitted. NRx is building 5 million units of launch stock and is targeting FDA approval/commercialization in 2026. Separately, it said it is advancing an NDA for NRX-100 in depression using real-world evidence from more than 65,000 patients; data presented at the American Society of Clinical Psychopharmacology meeting reportedly showed IV ketamine had greater or comparable efficacy and faster onset versus intranasal S-ketamine. The company aims to finalize the NDA for a 2027 approval target.

NRX-101 (D-cycloserine/lurasidone): NRx said DARPA selected it as prime contractor for the SPARC-TMS study, described as an FDA-approved Phase 2/3 trial of NRX-101 plus robotic TMS (NCT07227103), with anticipated non-dilutive funding of more than $11.5 million subject to contracting.

GeNeuro assets: NRx said it invested in Geneuro, including GNK-301 for ALS and Temelimab for schizophrenia, multiple sclerosis, and type 1 diabetes. A schizophrenia trial is planned, and GNK-301 first-in-human is targeted for July 2027.