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NRx Pharma Advances Ketamine Treatment for Depression with FDA Guidance

NRx Pharmaceuticals advances NRX-100 ketamine treatment for depression with FDA guidance, aiming for New Drug Application using real-world evidence from 65,000+ patients.

This news matters because it represents a potential breakthrough in treating severe mental health conditions like treatment-resistant depression with suicidality, which affect millions globally and have limited effective options. If approved, NRX-100 could provide a faster-acting, preservative-free ketamine formulation, addressing a critical need in psychiatry and reducing suicide risks. The FDA's guidance, indicating no need for additional studies, may accelerate approval, offering hope to patients and families while highlighting advancements in real-world evidence use in drug development. For investors, it signals progress in NRx's pipeline, potentially impacting stock performance and the broader biotech sector focused on CNS disorders.