NRx Pharmaceuticals, Inc.

What they do

NRx develops three lead drug candidates: KETAFREE, a generic preservative-free ketamine filed as an ANDA; NRX-100, a preservative-free IV ketamine for suicidal depression; and NRX-101, an oral D-cycloserine/lurasidone combination. Development runs through wholly-owned subsidiary NeuroRx, Inc. The company is also founder and majority owner of HOPE Therapeutics, which provides interventional psychiatry care for treatment-resistant depression and PTSD using neuroplastic drugs, TMS, digital therapeutics and hyperbaric therapy.

Revenue drivers

• KETAFREE (generic preservative-free ketamine) — ANDA filed with priority review requested in September 2025; the 10-K cites a current generic ketamine market exceeding $750 million per year. Commercial launch stock of 5 million units is in manufacturing with anticipated post-launch production of 1 million units per month.
• NRX-100 (preservative-free IV ketamine) — NDA in completion for treatment of suicidal ideation in depression, including bipolar depression, with Fast Track Designation. The 10-K states the labeled depression ketamine market is served only by intranasal S-ketamine (SPRAVATO), with estimated sales of approximately $2 billion per year.
• NRX-101 (D-cycloserine/lurasidone) — Holds Breakthrough Therapy Designation; Module 3 manufacturing file submitted as part of a rolling NDA. Selected for the DARPA-funded SPARC-TMS Phase 2/3 trial combining NRX-101 with robotic TMS.
• HOPE Therapeutics (interventional psychiatry services) — Clinics treating treatment-resistant depression and PTSD; expanded with new sites in Sarasota and Boca Raton, Florida, and became the first US commercial site to treat patients using Zeta Surgical's FDA-cleared TMS navigation system.

Recent performance

Revenue was $1.1 million in the quarter ended June 30, 2026, matching the prior quarter and up from $983,000 in Q4 2025 and $242,000 in Q3 2025. Full-year 2025 revenue was $1.2 million, the first reported revenue year after $0 in 2023 and 2024. Net loss was $28.6 million for 2025 versus $25.1 million for 2024, and operating cash flow was negative $14.1 million for 2025. At June 30, 2026 the company reported total assets of $34.2 million, total liabilities of $34.3 million, cash and equivalents of $26.7 million, and shareholder equity of negative $170,000.

Strategy

The priority is converting the pipeline to commercial revenue, led by the KETAFREE ANDA, where FDA identified no drug-related major deficiencies and the remaining luer-lock attestation has been submitted, with the company aiming for 2026 approval and commercialization. NRx is building launch inventory of 5 million units and has appointed Glenn Tyson as its first Chief Commercial Officer and retained a commercial launch team. The NRX-100 NDA is being advanced on Real World Evidence from more than 65,000 patients, with a stated goal of 2027 approval. For NRX-101, the company is pursuing a DARPA prime contract for the SPARC-TMS trial with anticipated non-dilutive funding exceeding $11.5 million, subject to completion of contracting. HOPE Therapeutics is expanding its clinical footprint and adopting new TMS navigation technology.

Risks

• Going-concern and capital need — The 10-K states the company needs to raise additional capital or it may be unable to continue as a going concern, and shareholder equity stood at negative $170,000 at June 30, 2026.
• No approved products yet — KETAFREE, NRX-100 and NRX-101 are all still in FDA submission or clinical testing, so revenue depends on approvals the company has not yet received.
• Early-stage clinical candidate — The 10-K states NRX-101 is still Phase 2/3 in clinical testing and no guarantees exist that pipeline products will receive regulatory approval or prove commercially successful.
• Manufacturing scale-up — The 10-K states the company has not yet scaled manufacturing of its drug products to levels required for sustained sales, and it is building 5 million units of launch stock with plans for 1 million units per month post-launch.

Outlook

Management targets KETAFREE approval and commercialization in 2026 and NRX-100 approval in 2027, with five million units of launch stock in manufacturing. The company says existing cash, following a $22.3 million gross underwritten public offering including full exercise of the underwriters' option, should fund operations for at least one year. NRX-101 could expand beyond suicidal bipolar depression into a broader depression market if the DARPA-selected SPARC-TMS trial succeeds. All of these are forward-looking statements subject to regulatory and financing risks.