The company’s abbreviated new drug application (ANDA) for preservative-free ketamine, referred to as KETAFREE pending a final FDA trade name decision, remains a central near-term catalyst. Dr. Javitt said FDA approved NRx’s suitability petition for the proposed strength in August 2025, and the company filed its ANDA in September 2025. In November, NRx received notification that FDA identified no significant deficiencies and agreed to review the file.
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Last week, the company was notified by FDA of a preliminary determination of bioequivalence to the reference branded drug Ketalar, which Dr. Javitt characterized as a key step in generic drug review. He added that room-temperature stability data support “at least 3 years” of stability, and that NRx has manufactured three registration batches in anticipation of a summer 2026 approval.
In Q&A, Dr. Javitt provided additional detail on inventory plans, stating the company has already manufactured three registration batches and asked its manufacturer for an initial production run. He said the company anticipates having 200,000 units in the warehouse at the time of generic approval. He also described KETAFREE’s manufacturing approach using a blow-fill-seal assembly line, which he said can produce large quantities efficiently and without human handling of vials.
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NRx also discussed a citizen petition seeking removal of benzethonium chloride, a preservative used in currently approved ketamine products. Dr. Javitt said FDA has informed the company the petition review is ongoing. He referenced a toxicology report posted to the public record and said the report raises questions about the chemical’s assumed safety, including potential cytotoxicity and neurotoxicity, while noting benzethonium chloride is not categorized by FDA as “Generally Recognized as Safe.”
Dr. Javitt also said NRx has filed a patent application related to its preservative-free ketamine product. He cited projections that the existing ketamine market is approximately $750 million annually, and argued KETAFREE could be a “superior option” given the lack of preservative and U.S.-based manufacturing.
NRx is also pursuing a new drug application (NDA) pathway for ketamine under Fast Track designation for NRX-100. Dr. Javitt said the company initially expected to rely on existing clinical trial data, but in the fourth quarter FDA announced a policy change inviting use of real-world evidence (RWE) to support effectiveness without requiring personally identifiable information. He said this allowed NRx to strengthen its approval case and pursue a broader indication and potentially full approval rather than accelerated approval.
NRx partnered with Osmind Inc. to access data from more than 65,000 patients treated with intravenous ketamine and approximately 6,000 treated with intranasal ketamine. Dr. Javitt said summary data are included in the 10-K and show benefits in reducing depression and suicidality for patients receiving IV ketamine.
Management said it held an in-person meeting at FDA headquarters with leadership from the Division of Psychiatry Products, the Office of Neuroscience, and the Center for Drug Evaluation and Research. Dr. Javitt said meeting minutes reflect FDA’s willingness to review both clinical trial and RWE data, and that FDA guidance supported seeking full approval and a broader indication for depression in patients who may have suicidality, rather than only those with active suicidality.
The company’s stated goal is to compile requested data by the end of Q2, with the potential for a PDUFA decision date by the end of 2026 or in early 2027.
Dr. Javitt added that manufacturing modules are complete and already with FDA, and that pre-registration batches have been produced and warehoused. He also said FDA granted an expanded Fast Track designation in August 2025, extending beyond suicidal bipolar depression to include “all patients with suicidal ideation and depression, including bipolar depression.”
NRx also discussed FDA’s Commissioner’s National Priority Voucher Program, which management said could enable substantially faster review times. Dr. Javitt said the company remains optimistic about the chance to receive a voucher, arguing NRX-100 meets the program’s criteria.
NRx described a strategic shift for NRX-101, originally developed as a fixed-dose combination of D-cycloserine and lurasidone for suicidal bipolar depression. While Dr. Javitt said the company hopes to return to the clinic with a pivotal trial for high-dose NRX-101 in that indication, he emphasized a nearer-term opportunity involving low-dose D-cycloserine (DCS) to augment TMS by driving neuroplasticity.
The company announced it is pursuing a “patentable sustained release” form of D-cycloserine intended to provide an extended-release profile during TMS treatment. Dr. Javitt cited prior clinical trials showing improved outcomes when DCS is combined with standard TMS, and said the company has identified a path to a more modern version of DCS designed to support steadier blood levels during treatment.
NRx appointed Joshua C. Brown, MD, PhD (McLean Hospital) as Chief Medical Innovation Officer, citing his involvement in NIH- and DARPA-funded projects related to neuroplastic care, including DCS and TMS for depression, PTSD, and suicidality.
NRx said it has more than 25,000 manufactured doses of NRX-101 at the appropriate strength and has launched a nationwide expanded access program allowing physicians performing TMS to access D-cycloserine at no charge to patients under expanded access and federal right-to-try laws, while the company awaits a confirmatory Phase III trial. Dr. Javitt said the trial is planned to begin this summer and that the company expects non-dilutive federal funding sources to support it. He cited a market estimate for the indication “in excess of $1 billion.”
On HOPE Therapeutics, Dr. Javitt said the subsidiary began generating revenue after acquiring Dura Medical in Naples and Fort Myers, Florida in September 2025 and later added Cohen & Associates in Sarasota, described as revenue-generating and EBITDA positive. He said Dr. Rebecca Cohen has been appointed HOPE’s medical director. In December, HOPE launched what management described as Florida’s first one-day TMS treatment for severe depression combining D-cycloserine and TMS, citing published literature on response and remission rates following a single day of treatment.
Dr. Javitt said HOPE is opening additional clinics in West Palm Beach, Sarasota, Boston, and Denver, with the expectation of a more robust network by year-end. The company also announced a partnership with neurocare group AG, maker of the Apollo TMS device, which Dr. Javitt said is installed at more than 400 U.S. clinical locations.
CFO Michael Abrams reported that for the year ended Dec. 31, 2025, NRx reduced its loss from operations by approximately $2.3 million to $16.2 million, compared with $18.5 million in 2024, primarily due to lower research and development spending. R&D expense fell approximately $2.4 million to $3.8 million from $6.2 million, driven mainly by reduced clinical trial and development expense. General and administrative expense declined by approximately $0.4 million to $13.1 million, which Abrams attributed to ongoing cost reduction initiatives.
As of Dec. 31, 2025, the company had approximately $7.8 million in cash and cash equivalents. Abrams said management believes current resources—together with anticipated clinic revenue growth, cost reductions, and availability under the company’s ATM offerings—will be sufficient to support operations through the end of 2026.
NRx Pharmaceuticals, Inc is a clinical-stage specialty biopharmaceutical company focused on the development and repurposing of small-molecule therapeutics for central nervous system and rare disease indications. The company’s research strategy centers on advancing compounds with established safety profiles into new neurological and inflammatory conditions, leveraging translational science and biomarker-driven trial design to accelerate clinical development. NRx’s pipeline includes Ifenprodil, an NMDA receptor antagonist in investigation for acute respiratory distress syndrome and inflammatory muscle disorders, as well as investigational formulations targeting depressive and cognitive disorders.
Since securing global rights to its lead assets, NRx has initiated multiple proof-of-concept studies in the United States and Europe, collaborating with academic institutions and clinical research organizations to evaluate safety and efficacy across a range of indications.
The article “NRx Pharmaceuticals Q4 Earnings Call Highlights” was originally published by MarketBeat.
