NRX Pharmaceuticals Soars 6.88% on FDA Fast Track Designation

NRX Pharmaceuticals' stock surged 6.88% in pre-market trading on August 27, 2025, driven by significant developments in its pipeline and regulatory approvals.

NRX Pharmaceuticals received Fast Track designation from the FDA for NRX-100, a ketamine-based therapy aimed at treating suicidal ideation in patients with depression. This designation is expected to accelerate the development and review process, potentially bringing the treatment to market faster.

The company also announced an expanded access policy for NRX-100, allowing more patients to access this preservative-free ketamine treatment. This move is part of NRX Pharmaceuticals' strategy to increase the likelihood of success for NRX-100, which has seen its success rate model updated from 70% to 80%.

Additionally, NRX Pharmaceuticals filed a Citizen Petition with the FDA seeking the removal of benzethonium chloride from certain drug products. This petition, if successful, could further enhance the safety and efficacy of NRX-100 and other treatments in development.