WILMINGTON, Del. – NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) has initiated the process for U.S. Food & Drug Administration (FDA) approval of its drug candidate NRX-100 (ketamine) for the treatment of suicidal depression. The company reported that the first section of its New Drug Application (NDA) has been transmitted for electronic filing with the FDA.
The NDA filing, which is expected to be completed in the first quarter of 2025, will include clinical data from trials funded by the National Institutes of Health (NIH) and European Government. NRX-100, which is a formulation of ketamine without potentially toxic preservatives, is intended for use in combination with NRX-101 (D-cycloserine/lurasidone) for treating suicidal bipolar depression. The company is expanding the indication to include suicidal ideation in Major Depressive Disorder and other forms of depression.
Currently, intravenous ketamine is used off-label for acute treatment of suicidal depression, with the Department of Defense and the Department of Veterans Affairs funding its use. However, it is largely unreimbursed by health insurers due to the lack of FDA approval. The only FDA-approved treatment for suicidal depression at the moment is electroconvulsive therapy (ECT).
FDA has requested the 1800-page manufacturing section (Module 3) of the NDA for immediate review, ahead of the final efficacy data. The company’s regulatory counsel has encouraged the NDA filing based on the trial data, seeing a potential market of $3-5 billion at expected pricing. However, InvestingPro analysis reveals that the company is currently burning through cash with an EBITDA of -$20.47 million in the last twelve months, and its short-term obligations exceed liquid assets with a current ratio of 0.2.
The company’s Chairman, CEO, and Chief Scientist, Dr. Jonathan Javitt, emphasized the urgent need for new treatment options for people at risk of acute suicidal depression. He noted that ketamine is already widely used for this purpose, albeit on an off-label basis.
NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics for central nervous system disorders. NRX-101, another drug candidate, has been designated as a Breakthrough Therapy for treatment-resistant bipolar depression and chronic pain by the FDA.
The company will also participate in 1x1 meetings during the Annual J.P. Morgan Healthcare Conference in San Francisco on January 13-16, 2025.
This news is based on a press release statement and contains forward-looking statements about the company’s future financial performance and the potential approval and market opportunity for NRX-100.
In other recent news, NRx Pharmaceuticals has made significant strides in product development and financial performance. The company’s third-quarter 2024 report highlighted a 74% reduction in net operating losses compared to the same quarter last year and the successful closure of a $10.8 million funding round. Notably, H.C. Wainwright has reaffirmed its Buy rating on NRx Pharmaceuticals, maintaining a steady price target of $19.00.
The company has made considerable advancements in the production and testing of its depression treatments, NRX-100 and NRX-101. Furthermore, NRx Pharmaceuticals has reached an agreement with the FDA regarding the Pediatric Study Plan for NRX-100. The company is on track to submit New Drug Applications for both treatments by the end of 2024.
In addition, the establishment of Hope Therapeutics, a wholly-owned subsidiary of NRx, aims to create a network of precision psychiatry clinics administering NRX-100. The company anticipates this development to generate significant revenue by the end of 2025. A public listing of Hope Therapeutics is also in the pipeline, following the finalization of its initial audit and SEC registration. These are some of the recent developments shaping the future of NRx Pharmaceuticals.
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