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NRx Pharmaceuticals Charts Path to NDA for NRX-100 Following FDA Guidance

Feb 17, 2026

NRx Pharmaceuticals completed a Type C meeting with the FDA, receiving guidance to file a New Drug Application for NRX-100 based on existing trial data and real-world evidence from over 65,000 patients, with submission planned for Q2 2026.

NRx Pharmaceuticals Receives FDA Guidance on New Drug Application Path for NRX-100

Feb 17, 2026

NRx Pharmaceuticals completed a Type C meeting with FDA leadership and received oral guidance supporting a New Drug Application for NRX-100 (preservative-free ketamine) based on existing trial data and Real World Evidence from over 65,000 patients.