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WILMINGTON, Del. - NRx Pharmaceuticals, Inc. (NASDAQ:NRXP), a clinical-stage biopharmaceutical company with a current market capitalization of $51 million, has submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) for NRX-100, a preservative-free intravenous (IV) ketamine formulation. The application comes in response to the ongoing U.S. drug shortage of ketamine, with the company aiming to provide an alternative that eliminates the use of benzethonium chloride, a preservative linked to neurotoxicity and cytotoxicity.
The current ketamine market is valued at $750 million, with projections suggesting a rise to $3.35 billion globally by 2034. NRx is positioning NRX-100 to meet the growing demand and to potentially replace existing ketamine formulations that contain toxic preservatives. According to InvestingPro data, the company’s stock has shown strong momentum with a 147.9% return over the past six months, though analysts note the company is not expected to be profitable this year. The company’s move aligns with the Department of Health and Human Services’ priorities to remove harmful preservatives from drugs and foods.
NRx has also announced plans to file a citizen’s petition with the FDA to mandate the removal of benzethonium chloride from all IV ketamine products in the U.S. This petition complements an ongoing New Drug Application (NDA) for NRX-100 to include the treatment of suicidal depression, with an expected Prescription Drug User Fee Act (PDUFA) date in late 2025.
The company’s CEO, Jonathan Javitt, highlighted the increasing demand for ketamine in the U.S. market and the inadequate supply. InvestingPro analysis shows the stock currently trades near its Fair Value, with analyst price targets ranging from $18 to $46, suggesting significant potential upside. The platform offers 12 additional exclusive ProTips for NRXP, providing deeper insights into the company’s financial health and market position. He emphasized the potential preference for safer, preservative-free formulations by physicians, patients, and regulators. NRx has filed a U.S. patent for NRX-100, which is anticipated to have three years of room-temperature shelf stability.
NRx Pharmaceuticals is also developing other therapeutics, including NRX-101 for suicidal bipolar depression and chronic pain, and has initiated an NDA filing for NRX-100 for suicidal depression. With an overall Financial Health score of FAIR from InvestingPro, the company operates with moderate debt levels while maintaining its development pipeline. For comprehensive analysis, investors can access the detailed Pro Research Report, available exclusively to InvestingPro subscribers, covering all crucial aspects of NRXP’s business model and growth potential. The company has been granted Fast Track Designation by the FDA for the development of ketamine in treating acute suicidality and has filed a patent for this novel formulation.
The information in this article is based on a press release statement from NRx Pharmaceuticals, Inc.
In other recent news, NRx Pharmaceuticals reported a net loss of $5.5 million for the first quarter of 2025, an improvement from the $6.5 million loss in the same period last year. The company is optimistic about achieving profitability by the end of 2025, driven by potential FDA approvals and strategic expansion plans. NRx Pharmaceuticals has filed a New Drug Application (NDA) for NRx100, a ketamine-based treatment, and anticipates FDA approval of key drugs in 2025. The company is also focusing on expanding its clinic network, which is expected to generate revenue before the end of the year. Additionally, NRx Pharmaceuticals has reduced its operating loss to $3.8 million from $6 million in the previous year. The company ended the quarter with $5.5 million in cash and cash equivalents as of March 31, 2025. These developments indicate a strategic focus on innovative treatments for depression and PTSD while managing financial sustainability.
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