KETAFREE

May 18, 2026: NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) reported Q1 2026 results and provided regulatory and pipeline updates across NRX-100/KETAFREE, NRX-101, HOPE Therapeutics, and a pending Geneuro asset acquisition.

KETAFREE / preservative-free ketamine (ANDA): FDA Office of Generic Drugs review progressed with “no major deficiencies,” with favorable preliminary determinations noted on bioequivalence, labeling, drug product/drug substance, and safety. FDA reclassified the manufacturing site to “VAI” status; NRx initiated commercial manufacturing at ~1 million units per batch (also cited as 1 million doses/month). FDA aims to complete review by Summer 2026; the company anticipates an FDA decision in Q3 2026.

NRX-100 (preservative-free IV ketamine; NDA): NDA expected to be filed in Q2 2026, supported by >1,000 clinical-trial patients and Real World Evidence from >65,000 U.S. patients via Osmind. Following a Type C meeting, FDA agreed to consider both data sources.

NRX-101 (D-cycloserine/lurasidone): For suicidal bipolar depression, the company initiated NDA filing (Module 3 submitted) and is seeking rolling review. Separately, FDA cleared the MIND1 Phase 2b/3 trial (n=400) of NRX-101 vs placebo as an adjunct to robotic-assisted TMS with a one-day protocol; non-dilutive U.S. government funding is anticipated.

Geneuro assets: NRx said it submitted the winning bid in a Swiss liquidation process; acquisition expected to close in Q2 2026 and includes IP, antibodies/cell lines, regulatory files, and data from three completed human trials targeting HERVs implicated in multiple CNS/immune diseases.