NRx Pharmaceuticals, Inc. NRXP
NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) is a CNS/neurology/psychiatry drug developer. Its lead program, NRX-100 (preservative-free IV ketamine) / NRX-101 (D-cycloserine + lurasidone), is in Phase 3 for Suicidal ideation in depression incl. bipolar depression (NRX-100); suicidal bipolar depression (NRX-101). Its next catalyst on record is KETAFREE: Commercial launch following ANDA approval (Q4 2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: KETAFREE — Commercial launch following ANDA approval (Q4 2026). 2 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| NRX-100 (IV ketamine) | Suicidal ideation in depression, including bipolar depression | small molecule | Phase 3 |
| NRX-101 (D-cycloserine/lurasidone) | Suicidal bipolar depression; NRX-101 + TMS | small molecule | Phase 3 |
| Temelimab (GeNeuro, anti-HERV-W antibody) | MS, type 1 diabetes, schizophrenia/psychosis | antibody | Phase 2 |
| NRX-200 (pH-neutral ketamine, subcutaneous) | Depression | small molecule | Pre-clinical |
| GNK-301 (anti-HERV-K antibody) | ALS | antibody | Pre-clinical |
| KETAFREE (generic preservative-free ketamine, ANDA) | Anesthesia/generic ketamine market | small molecule | NA_NON_THERAPEUTIC |
Recent results and decisions
- Jul 30, 2026n/a FDA first-round ANDA review of preservative-free ketamine found no major drug-component deficiencies but one major container-closure (luer lock vial tip) deficiency plus a labeling update; FDA committed to re-initiate review.
The FDA advised the Company on July 30, 2026 of a final determination on first-round review that there were no major deficiencies related to the drug components of the product.
Filing
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 CNS/neurology/psychiatry companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.