This expanded access approval is a modest positive for NRX-101's development pathway but does not change the binary risk of the ongoing SPARC-TMS pivotal trial. Traders should watch for enrollment updates and eventual topline data from the trial, which will determine the drug's commercial viability. No immediate revenue impact is expected.
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Executive Summary
NRx Pharmaceuticals announced FDA approval of an Expanded Access Protocol for NRX-101 (D-cycloserine/lurasidone) to augment Transcranial Magnetic Stimulation (TMS) in patients with Treatment-Resistant Depression. The company will initially charge only for shipping and data collection costs, not for the investigational drug, while a pivotal trial (SPARC-TMS) is underway. This is a procedural regulatory step that provides compassionate access but does not change the drug's approval status or provide new efficacy data.
Key Facts
- FDA approved an Intermediate Population Expanded Access Protocol for NRX-101 to augment accelerated TMS in Treatment-Resistant Depression.
- NRX-101 is a fixed-dose combination of D-cycloserine and lurasidone, with Breakthrough Therapy Designation for suicidal bipolar depression.
- Company will initially charge only for shipping and FDA-required data collection costs, not for the investigational drug.
- Pivotal trial SPARC-TMS is ongoing in civilian and military treatment facilities.
- NRX-100 (preservative-free IV ketamine) has Fast Track Designation for suicidal ideation in depression.
Financial Impact
No financial terms disclosed; company charging only shipping and data costs initially.
Risk Factors
- Expanded access does not guarantee eventual FDA approval or commercial success.
- Pivotal trial (SPARC-TMS) may fail to meet endpoints, which would severely impact valuation.
- Compounded D-cycloserine competition exists, though company claims quality advantages.
- Clinical-stage biopharma with no approved products and limited cash runway.
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3315163 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Sep 16, 2026 16d ago | 8-K | $3.35 $3.16 | ▼ −5.67% | ▼ −8.24% | $2.90 (−13.28%) |
Sep 14, 2026 18d ago | 8-K | $3.49 $3.29 | ▼ −5.73% | ▼ −5.84% | $2.90 (−16.76%) |
Aug 17, 2026 6w ago | 8-K | $3.43 $3.45 | ▲ +0.58% | ▲ +1.77% | $2.90 (−15.31%) |
Aug 17, 2026 6w ago | Press Release | $3.43 $3.45 | ▲ +0.58% | ▲ +1.77% | $2.90 (−15.31%) |
Aug 7, 2026 8w ago | 8-K | $3.58 $3.27 | ▼ −8.66% | ▼ −9.06% | $2.90 (−18.85%) |
Jul 22, 2026 10w ago | 8-K | $4.48 $3.23 | ▼ −27.90% | ▼ −25.50% | $2.90 (−35.16%) |
Jun 22, 2026 14w ago | Press Release | $3.90 $3.73 | ▼ −4.36% | ▼ −2.29% | $2.90 (−25.51%) |
Jun 5, 2026 17w ago | Press Release | $4.14 $3.84 | ▼ −7.25% | ▼ −7.82% | $2.90 (−29.83%) |
Jun 4, 2026 17w ago | Press Release | $4.14 $3.84 | ▲ +7.25% | ▲ +7.82% | $2.90 (+29.83%) |
Jun 3, 2026 17w ago | Press Release | $4.05 $3.76 | ▲ +7.16% | ▲ +3.34% | $2.90 (+28.27%) |
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