Summary of the Article/Press Release
On December 18, 2025, NRx Pharmaceuticals, Inc. (Nasdaq: NRXP), a clinical-stage biopharmaceutical company focused on treatments for central nervous system disorders like suicidal depression and PTSD, announced that it has fully eliminated its balance sheet debt.
- The company repaid the remaining $5.4 million owed to Anson Funds, LLC, by converting it into common stock equity.
- The conversion included no additional warrants or repricing/adjustment provisions.
- Originally, Anson had provided loans totaling around $16.2 million to support prior debt repayment and operations.
- As a result, NRx anticipates its December 31, 2025, balance sheet will show no outstanding convertible debt, making the company effectively debt-free.
CEO Dr. Jonathan Javitt thanked Anson Funds for their support during tough biotech market conditions and stated that this clean balance sheet positions the company for accelerated growth in 2026, including potential drug approvals (e.g., for NRX-100 preservative-free IV ketamine and NRX-101) and expansions of its HOPE Therapeutics clinic network.
This milestone strengthens NRx’s financial position amid ongoing development of its NMDA-platform therapeutics.
Overview of NRX-101
NRX-101 is an investigational oral fixed-dose combination of D-cycloserine (an NMDA receptor modulator) and lurasidone (a 5-HT2A antagonist, already approved for bipolar depression). It is being developed by NRx Pharmaceuticals primarily for suicidal treatment-resistant bipolar depression, with potential extensions to chronic pain, PTSD, and complicated urinary tract infections.
It targets patients with severe bipolar depression and acute or subacute suicidal ideation/behavior (ASIB/SSIB), a condition with no approved pharmacologic treatments (only electroconvulsive therapy is FDA-approved).
FDA Regulatory Designations
- Breakthrough Therapy Designation (BTD): Granted in 2018 based on Phase 2 data showing superior reduction in depression and suicidality compared to standard care.
- Fast Track Designation: Supports expedited development.
- Special Protocol Agreement (SPA): FDA agreement on pivotal trial design (remains in effect as of recent updates).
- These designations enable rolling NDA review, more frequent FDA interactions, and potential priority review.
Clinical Trial Basis
- Phase 2 STABIL-B Trial: Demonstrated statistically significant reductions in depression and suicidality vs. lurasidone alone after initial ketamine stabilization.
- Phase 2b/3 Trial: Showed comparable antidepressant efficacy to lurasidone but superior safety (significantly reduced akathisia, a side effect linked to suicide risk). Akathisia occurred in ~2% of NRX-101 patients vs. ~11% on lurasidone.
- Additional real-world data supports augmentation of transcranial magnetic stimulation (TMS) for depression.
Approval Pathway: Accelerated Approval
NRx is pursuing Accelerated Approval under FDA’s expedited program for serious conditions with unmet need. This allows approval based on surrogate endpoints (e.g., reduction in akathisia and suicidality scores) likely to predict clinical benefit, rather than requiring full confirmatory Phase 3 outcomes upfront.
- Indication Focus: Bipolar depression with akathisia or active suicidality despite standard treatment.
- Post-Approval Requirement: Confirmatory trials to verify clinical benefit (e.g., larger Phase 3 studies).
- Contingent on manufacturing stability data (e.g., 12-month data) and full clinical package.
Current Status (as of December 30, 2025)
- NDA filing initiated in 2025 (e.g., Module 3 manufacturing submitted; over 80,000 pages of data transmitted).
- Rolling review requested due to BTD.
- Company anticipates potential PDUFA decision in 2026 (earlier guidance suggested mid-2025, but updates indicate ongoing submission).
- Recent expansions: IND amended for use with TMS; expanded access policy for severe cases.
NRX-101 is not yet approved; the process is ongoing, with Accelerated Approval as the targeted pathway to potentially bring it to market faster for this high-unmet-need population.