OTC:NRXBF
READ THE FULL NRXBF RESEARCH REPORT
NurExone (OTC:NRXBF) is developing a product known as ExoPTEN that is designed to treat patients with acute spinal cord injuries and these numbers suggest a potential market for ExoPTEN of approximately 50,000 new cases globally per year—an enormous market potential with patients eager to have the opportunity to return to some form of normalcy and dramatically improve their quality of life.
The company recently announced that its ExoPTEN therapy has received the Orphan Medicinal Product Designation by the European Medicines Agency (EMA). According to the company, the EMA’s Orphan Medicinal Product Designation offers incentives, including ten years of market exclusivity upon approval, access to grants and incentives from the European Commission and member states. Additionally, the company may benefit from free or reduced-cost scientific advice and assistance with clinical trial design, which can streamline the regulatory process and reduce development costs. Lastly, some European Union countries also provide tax credits and other financial incentives to support orphan drug development.
As we’ve noted before, the company received the Orphan Drug Designation for ExoPTEN in 2023 from the FDA in the United States. This designation was created by the FDA which noted that supporting the development and evaluation of new treatments for rare diseases is a key priority for the agency. The FDA has authority to grant orphan drug designation to a drug or biological product to prevent, diagnose or treat a rare disease or condition. Orphan drug designation qualifies sponsors for incentives including:
- Tax credits for qualified clinical trials
- Exemption from user fees
- Potential seven years of market exclusivity after approval
This announcement of Europe further illustrates in our view the potential that government agencies see in the treatment being developed by NurExone.
As a reminder, it was the test results from the use of ExoPTEN that sparked our enthusiasm for the company, because the initial test results are, in our view, truly remarkable. This isn’t a potential treatment that was arrived at quickly or easily as research began at the University level and was conducted between January 2017 and May 2020, including testing the use of intranasal administration of exosomes driven from mesenchymal stem cells loaded with siRNA (a process that is described in more detail below). Testing targeted a complete spinal cord transection in rats, which is the strictest animal testing model, successfully demonstrating significant functional recovery. The company notes that the technology is successfully proven in additional preclinical studies, demonstrating that intranasal administration of ExoPTEN led to significant motor improvement, sensory recovery, and faster urinary reflex restoration. As mentioned, the research began at the University level and the Company has been granted an exclusive worldwide license from the Technion and Tel Aviv University, which includes a patent application, to develop and commercialize the technology. In addition, the Company has developed its own intellectual property and now has five families of patents.
We continue to be enthusiastic about the prospect for NurExone and this recent announcement supports that enthusiasm. We urge investors with a higher risk tolerance to take a look at NRXBF and consider whether this compelling story may be of interest.
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