FDA Fast Track for NRX-100 in suicidal depression; ANDA filing deficiency noted

NRX Pharmaceuticals, Inc.

• FDA Fast Track designation for NRX-100 (IV ketamine) to treat suicidal ideation in depression, including bipolar depression.
• Addressable population expands to 13M Americans considering suicide/year, 10x larger than prior 2017 designation.
• Company also received FDA letter on August 13 citing missing batch records and 6% inactive ingredient difference in ANDA for NRX-100; expects to remedy and resubmit.
• Fast Track enables potential CNPV/accelerated approval, rolling review, and enhanced FDA communication.
• NRX-100 is preservative-free ketamine; company citizen petition to remove BZT from IV ketamine products.