Nrx Pharmaceuticals Inc (NRXP) — Smart Money Tracker (13F, Q2 2026)

AI summary pending

NRX Pharmaceuticals said the FDA completed its first-round review of the company's abbreviated new drug application (ANDA) for preservative-free ketamine and found no major deficiencies with the drug itself. However, the FDA flagged a packaging issue — a concern that the tip of the luer-lock vial could deform in clinical use — and asked for a label update. After a clarification meeting on August 6, the company said the FDA committed to restarting the review immediately to resolve that single issue as quickly as possible. Management called the first-round result positive, noting only 14%-18% of ANDAs typically pass first-round review.

NRx Pharmaceuticals announced that its subsidiary NRx Defense Systems (NRXD) received a letter from DARPA stating that its proposal for the SPARC-TMS clinical trial has been selected for negotiation of a potential award. The Phase 2/3 trial combines robot-enabled transcranial magnetic stimulation with the company's patented NRX-101 for depression, planned at Harvard McLean, HOPE clinics, and military facilities including Walter Reed. The company emphasizes that selection for negotiation does not mean an award is guaranteed, and final terms are still subject to negotiation.