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WILMINGTON, Del. - NRx Pharmaceuticals, Inc. (NASDAQ:NRXP), a pharmaceutical company with a market capitalization of $70 million, has re-filed an Abbreviated New Drug Application (ANDA) with the FDA for KETAFREE, a preservative-free intravenous ketamine formulation for existing approved indications, the company announced Monday.
The filing follows FDA approval of the company’s Suitability Petition for its proposed strength of preservative-free ketamine. NRx is seeking priority review due to the current ketamine shortage listed by the American Society of Hospital Pharmacists.
The company’s formulation eliminates benzethonium chloride (BZT), a preservative NRx describes as neurotoxic and cytotoxic. NRx has previously filed a citizen’s petition with the FDA requesting removal of BZT from intravenous ketamine products.
"KETAFREE is designed to replace older formulations that rely on potentially neurotoxic and cytotoxic preservatives for stability and sterility, and to reshore the manufacture of a strategically-important drug to the US," said Jonathan Javitt, Chairman and CEO of NRx Pharmaceuticals.
The product is manufactured in partnership with Nephron Pharmaceuticals of West Columbia, South Carolina, aligning with a May 5, 2025 Presidential executive order prioritizing US manufacturing of strategic drugs.
NRx estimates the current ketamine market at $750 million annually, with global demand projected to reach $3.35 billion by 2034. According to a 2021 survey cited in the company’s press release, an estimated 5.1 million Americans have received ketamine for medical purposes. The company’s stock has shown strong momentum, gaining over 68% in the past year according to InvestingPro data, though analysts note the company faces near-term profitability challenges. InvestingPro analysis indicates the stock is currently trading near its Fair Value.
The company noted this ketamine formulation differs from the one used in its separate New Drug Application for NRX-100, which recently received Fast Track Designation for treatment of suicidal ideation in depression.
NRx has filed a US patent on its preservative-free formulation, which it says anticipates three years of room-temperature shelf stability.
In other recent news, NRx Pharmaceuticals has made significant strides with its products and strategic acquisitions. The U.S. Food and Drug Administration granted a Suitability Petition for NRx’s KETAFREE™, a preservative-free ketamine product, allowing the company to refile its Abbreviated New Drug Application. Additionally, the FDA has granted Fast Track designation for NRX-100, aimed at treating suicidal ideation in depression, including bipolar depression, and it is now available on an expanded access basis for patients with severe conditions. NRx Pharmaceuticals has also expanded its mental health services through the acquisition of Dura Medical, which will contribute to a network providing treatments for depression and PTSD in Florida.
In terms of analyst activity, H.C. Wainwright has assumed coverage on NRx Pharmaceuticals with a Buy rating, noting the company’s dual strategy in therapeutics and mental health care delivery. Furthermore, D. Boral Capital has increased its price target for NRx Pharmaceuticals to $34 from $31, maintaining a Buy rating, reflecting increased confidence in the success of NRX-100. These developments underscore the company’s ongoing efforts to address urgent needs in mental health treatment.
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