NRx Pharmaceuticals
NRX-101 · D-Cycloserine + Lurasidone · Suicidal Bipolar Depression
Company Overview
NRx Pharmaceuticals is developing NRX-101, a fixed-dose combination of D-cycloserine and lurasidone, for the treatment of Suicidal Bipolar Depression — used as a follow-on oral therapy after IV ketamine stabilization. The Phase 2b/3 STABIL-B trial was COMPLETED in April-May 2024, showing comparable antidepressant efficacy with a 76% reduction in akathisia (p=0.03). NRx is now pursuing NDA for Accelerated Approval, with a Type C FDA meeting held February 17, 2026 supporting the NDA path. All debt was eliminated in December 2025. ⚠ WARNING: Going concern doubt has been disclosed; as of Q3 2025 the company had only ~$7.1M in cash and an accumulated deficit of $307M. Also pursuing a KETAFREE generic ketamine ANDA with FDA goal date July 29, 2026.
Pipeline
| Drug / Compound | Stage | Indication |
|---|---|---|
NRX-101 D-Cycloserine + Lurasidone (fixed dose combination) | Phase 2b/3 Complete | Suicidal Bipolar Depression |
KETAFREE Generic racemic ketamine | ANDA | Treatment-Resistant Depression |
Key Financials
- Cash Position
- ~$7.1M
- Burn Rate
- ~$3M/quarter
- Last Reported
- Q3 2025
Financial data is approximate. Always verify with official SEC filings.
Upcoming Catalysts
- July 29, 2026KETAFREE generic ketamine ANDA — FDA goal dateRegulatory
- H2 2026NRX-101 NDA submission for Accelerated Approval (Suicidal Bipolar Depression)Regulatory
Recent News
- 2026-02Type C FDA meeting held February 17, 2026 — supports NDA path for NRX-101 in Suicidal Bipolar Depression
- 2025-12NRx eliminates all outstanding debt, December 2025
- 2024-05NRx Phase 2b/3 STABIL-B trial completes: NRX-101 meets endpoints with 76% reduction in akathisia
News items are manually curated from public company press releases.
External Links
Looking for psychedelic therapy?
Browse our directory of 700+ verified ketamine and psychedelic therapy clinics across 49 states. Find providers near you who offer ketamine and psychedelic-assisted therapy.
Disclaimer: This page is for informational purposes only and does not constitute investment, medical, or financial advice. Pipeline status, financial figures, and catalyst dates are approximate and based on publicly available information as of 2026-02-25. Always consult official company filings and a qualified financial advisor before making investment decisions.