NRx Pharma announces FDA path to NDA for NRX-100 with broader TRD+suicidality indication

NRX Pharmaceuticals, Inc.

FDA meeting provided clear path to submit NDA for NRX-100 under Fast Track; endpoints support full approval rather than Accelerated Approval.
Indication expanded to treatment-resistant depression with suicidality, targeting over 10 million TRD patients.
Real World Evidence from 65,000+ patient dataset to be used as confirmatory data; FDA to review analysis protocol.
NDA submission planned for Q2 2026; PDUFA date anticipated in 2026.
ANDA for generic ketamine remains under review with decision expected Summer 2026.

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