---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-26-004246"
form_type: "8-K"
ticker: "NRXP"
cik: "0001719406"
company_name: "NRX Pharmaceuticals, Inc."
filed_at: "2026-02-17T23:59:59+00:00"
generated_at: "2026-05-16T02:28:24.094916+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0001437749-26-004246
- form_type: 8-K
- ticker: NRXP
- cik: 0001719406
- company_name: NRX Pharmaceuticals, Inc.
- filed_at: 2026-02-17T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1719406/000143774926004246/0001437749-26-004246-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1719406/000143774926004246/nrxp20260216c_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-26-004246
- JSON: https://secwatch.observer/filing/0001437749-26-004246.json
- Plain text: https://secwatch.observer/filing/0001437749-26-004246.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.