Recent Updates — NRXP
NRx Pharmaceuticals subsidiary NRx Defense Systems entered into a prime contract with the Defense Advanced Research Projects Agency (DARPA) valued at approximately $11.2 million to conduct the SPARC-TMS clinical trial. The agreement includes an initial obligation of $6.7 million, with additional funding subject to appropriations and option exercises over an 18-month performance period. The trial evaluates a single-day robotic transcranial magnetic stimulation protocol combined with investigational drug NRX-101 for treatment-resistant depression. FDA approval has been granted, and patient enrollment is expected to begin shortly at sites including Harvard Medical School’s McLean Hospital. NRx Pharmaceuticals operates as a clinical-stage biopharmaceutical company developing therapeutics for central nervous system disorders.
NRx Pharmaceuticals announced that the FDA reclassified an amendment to its Abbreviated New Drug Application for preservative-free ketamine from a Major Amendment to a Minor Amendment. This change revised the GDUFA goal date to November 10, 2026, as the minor classification does not require substantial FDA resource expenditure. The company operates in the biopharmaceutical industry.