Monitor initial commercial uptake and revenue disclosures in upcoming quarterly filings. The company's transition from clinical-stage to commercial-stage with an approved product that addresses a drug shortage could drive significant valuation changes. Also watch for FDA response to the Citizen Petition to remove BZT from all ketamine products, which could expand NRx's market opportunity.
Price Chart
Executive Summary
NRx Pharmaceuticals announced FDA approval of its Abbreviated New Drug Application (ANDA) for Preservative-Free Ketamine, a novel formulation that eliminates the toxic preservative benzethonium chloride (BZT). The approval came ahead of the November 10 GDUFA goal date, and the company has commercial supply on hand to begin labeling and distribution. This is a significant milestone for NRx, a clinical-stage biotech with a $116M market cap, as it transitions to commercial-stage with its first approved product.
Key Facts
- FDA approved NRx's ANDA for Preservative-Free Ketamine ahead of the November 10 goal date.
- Preservative-Free Ketamine contains no benzethonium chloride (BZT), a toxic preservative not GRAS by FDA.
- NRx has manufactured commercial supply on hand and can immediately label and supply U.S. hospitals and clinics.
- Ketamine injection has been on the FDA drug shortage list since 2018; this approval addresses a strategic drug supply issue.
- NRx partnered with Nephron Pharmaceuticals in West Columbia, SC for U.S.-based manufacturing using blow-fill-seal technology.
- The company also received an $11.25M DARPA contract in October 2026 for a phase 3 trial of NRX-101.
- NRX-100 (intravenous ketamine) has Fast Track Designation for suicidal ideation in depression; NRX-101 has Breakthrough Therapy Designation for suicidal bipolar depression.
Financial Impact
First commercial product for a $116M market cap company; ketamine is a multi-hundred-million-dollar U.S. market with chronic shortage; revenue potential not quantified in filing.
Risk Factors
- Commercial execution risk: NRx has no prior track record of selling a commercial product.
- Competition from other ketamine formulations (including those with BZT) that remain on the market.
- Dependence on Nephron Pharmaceuticals for manufacturing; any supply chain disruption could impact revenue.
- Regulatory risk: FDA may not act favorably on the Citizen Petition to remove BZT from competitor products.
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3392146 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 30, 2026 2d ago | Press Release | $3.00 | awaiting T+60 | awaiting T+60 | $2.27 (−24.33%) |
Oct 16, 2026 16d ago | 8-K | $2.63 | awaiting T+60 | awaiting T+60 | $2.27 (−13.69%) |
Oct 5, 2026 27d ago | 8-K | $2.94 | awaiting T+60 | awaiting T+60 | $2.27 (−22.79%) |
Sep 15, 2026 6w ago | 8-K | $3.35 | awaiting T+60 | awaiting T+60 | $2.27 (−32.24%) |
Sep 14, 2026 6w ago | 8-K | $3.49 | awaiting T+60 | awaiting T+60 | $2.27 (−34.96%) |
Aug 17, 2026 10w ago | 8-K | $3.43 | awaiting T+60 | awaiting T+60 | $2.27 (−33.82%) |
Aug 17, 2026 10w ago | Press Release | $3.43 | awaiting T+60 | awaiting T+60 | $2.27 (−33.82%) |
Aug 7, 2026 12w ago | 8-K | $3.58 | awaiting T+60 | awaiting T+60 | $2.27 (−36.59%) |
Jul 22, 2026 14w ago | 8-K | $4.48 $2.71 | ▼ −39.51% | ▼ −42.77% | $2.27 (−49.33%) |
Jun 22, 2026 18w ago | Press Release | $3.90 $3.40 | ▼ −12.82% | ▼ −14.57% | $2.27 (−41.79%) |
US Market Status
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