Take a look at a blue chip like Rio Tinto (NYSE: RIO) who has investor’s attention as metal prices rise and now for a new CCI indicator buy signal, or NerdWallet, Inc. (Nasdaq: NRDS) who spiked recently on a huge surge in volume upon a better than expected quarter, or North American Construction Group Ltd. (TSX: NOA) (NYSE: NOA) whose chart just made a bullish engulfing pattern as it looks to keep the uptrend ahead of a financial report.
And then there’s NurExone Biologic Inc. (TSX-Venture: NRX), an upstart biotech that is developing a next-generation biologically guided ExoTherapy to non-invasively delivery targeted therapy for patients that suffered traumatic spinal cord injuries. ExoTherapy is licensed from the Technion and Tel Aviv University, where it initially demonstrated its robust capacity.
Proof of principle of the technology was shown in rat models where animals with completely severed spinal cords and paralyzed rear legs were treated with ExoTherapy. ExoTherapy uses extracellular vesicles called exosomes to deliver molecular payloads to damaged tissue. Exosomes are growing in popularity as naturally occurring biological entities that work symbiotically with the innate immune system to precisely transport therapeutics to targets.
The therapeutic, branded ExoPTEN, reversed paralysis in the laboratory rats, enabling them to walk again.
In a world where those suffering spinal cord damage have almost no effective options, ExoTherapy and ExoPTEN are reasons for tremendous optimism. Building on the proof of principle in animal models, NurExone is taking it to the next level, preparing for clinical trials to first evaluate the safety of the treatment and then for signs of efficacy.
These trials will be of intense interest to the medical community, patients, and investors alike.
The Israel-based company was recently being awarded a 1 million New Israeli Shekels (NIS) (~CAD$350K) grant by the Israel Innovation Authority as part of the Israel-Canada bilateral Eureka program. Also, this month, NurExone welcomed Professor Teodoro Forcht Dagi, a renowned neurosurgeon, life science venture capitalist and professor at the Mayo Clinic Alix School of Medicine as well as at Queen’s University Belfast, to its esteemed Scientific Advisory Board and Advisory Committee.
Lastly, the big news this week was the company announcing that the U.S. Food and Drug Administration (FDA) had granted Orphan-Drug Designation (ODD) to the Company’s ExoPTEN therapy.
The goal of orphan drug designation is to provide increased access to therapies for patients. In addition, it provides significant benefits to pharmaceutical companies developing drugs for rare diseases, defined as those impacting fewer than 200,000 people in the United States. Benefits include market exclusivity, financial incentives, regulatory assistance, and support with drug development. Overall, the designation incentivizes and supports the development of certain treatments, increasing access to therapies for patients.
It can’t be overstated, earning orphan-drug designation is a significant milestone for the Company. Commenting on the FDA granting the ODD, Dr. Shaltiel, CEO of NurExone Biologic, Ltd. said “Orphan-drug designation is expected to streamline our go-to-market, shorten our regulatory process saving the Company millions of dollars, and provide valuable market exclusivity. We appreciate the formal recognition of the potential impact of our therapy on the lives of patients suffering from acute spinal cord injuries”.
The fundamentals and technology are solid, and investors are taking note as evidenced by shares climbing from C$0.20 to C$0.31 (+55%) in about five weeks.
Take a look at the rise over the last month or so. Shares have been steadily climbing and the chart looks great for continuation. A longer look shows that there is some resistance in the area of 31 Canadian cents and then things open up for NRX to the 52-week high at C$0.42 (+36% from the current level).
If this chart is met with news of more fundamental strength, it seems possible that a new 52-week high could be in the cards.
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NurExone Biologic Inc. (TSX-Venture: NRX) Full Corporate Write-Up: Click Here.
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