RADNOR, Pa. - NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) announced today that it has achieved a significant stability milestone for its preservative-free ketamine formulation, NRX-100, which is intended for treating suicidal depression. On September 24, 2024, the company reached twelve-month real-time stability for the first manufactured lot of NRX-100, with no degradation of the active ingredient noted. This suggests a projected room temperature shelf life exceeding three years.
The stability achievement is a critical step toward the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA). Currently, ketamine is used off-label for the treatment of suicidal depression, but FDA approval could facilitate insurance reimbursement for patients. NRX-100 is the first sterile, single-dose vial of ketamine prepared without preservatives, aiming to avoid the potential toxic side effects associated with preservatives in existing formulations.
Jonathan Javitt, MD, MPH, Chairman and Chief Scientist of NRx Pharmaceuticals, expressed optimism about the potential impact of NRX-100, referencing the millions of Americans who plan suicide each year. The company’s partnership with Nephron Pharmaceuticals has been instrumental in reaching this milestone.
NRx Pharmaceuticals is focused on developing treatments for central nervous system disorders through its NMDA platform. Beyond NRX-100, the company is working on NRX-101 for treatment-resistant bipolar depression and chronic pain, which has received an FDA Breakthrough Therapy designation.
The announcement follows NRx's plans to submit an NDA for NRX-100, supported by clinical trial results and data sharing agreements with French health authorities. Furthermore, the FDA has granted Fast Track Designation to the development protocol of ketamine for treating acute suicidality.
This news is based on a press release statement from NRx Pharmaceuticals, Inc. Investors are reminded that forward-looking statements are subject to risks and uncertainties, and actual results may differ materially. The company's filings with the Securities and Exchange Commission provide further information about these risks.
In other recent news, NRx Pharmaceuticals and its subsidiary, HOPE Therapeutics, have seen significant advances. HOPE Therapeutics has secured a $30 million term sheet for non-dilutive financing to support the acquisition of its first interventional psychiatry clinics. These clinics are currently operational and generate annual revenue of over $10 million. With continued acquisitions, HOPE Therapeutics projects annualized revenues of $100 million by mid-2025.
Simultaneously, NRx Pharmaceuticals has initiated a search for a new CEO with substantial experience in commercial pharmaceuticals and drug launches. This move aligns with the company's upcoming filing of New Drug Applications for its product candidates, NRX-100 and NRX-101, aimed at treating suicidal depression.
Financially, NRx Pharmaceuticals has secured a critical investor, clearing toxic debt, and has reduced its net loss and research and development expenses. The company has secured $16 million in senior secured debt financing to support drug applications and the launch of therapeutics. These are recent developments that highlight the strategic efforts of NRx Pharmaceuticals and HOPE Therapeutics towards innovation and financial stability.
InvestingPro Insights
While NRx Pharmaceuticals (NASDAQ: NRXP) has made significant progress with its NRX-100 ketamine formulation, investors should be aware of the company's financial challenges. According to InvestingPro data, NRXP has a market capitalization of just $18.69 million, reflecting its status as a small-cap biopharmaceutical company.
InvestingPro Tips highlight that NRXP is "quickly burning through cash" and "short term obligations exceed liquid assets." These factors are particularly relevant given the capital-intensive nature of drug development and the regulatory hurdles the company faces in bringing NRX-100 to market.
The company's financial performance is also concerning, with an adjusted operating income of -$23.26 million for the last twelve months as of Q2 2023. This aligns with another InvestingPro Tip indicating that NRXP is "not profitable over the last twelve months."
Despite these challenges, it's worth noting that NRXP's stock has shown some recent positive momentum, with a 1-week price total return of 6.06%. However, this should be viewed in the context of longer-term performance, as the 6-month price total return stands at -62.92%.
Investors considering NRXP should be aware that InvestingPro offers 8 additional tips for this stock, providing a more comprehensive analysis of the company's financial health and market position.
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