11:12:47 EDT Fri 12 Apr 2024
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Nurexone Biologic Inc
Symbol NRX
Shares Issued 55,341,700
Close 2024-02-01 C$ 0.305
Market Cap C$ 16,879,219
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Nurexone starts European regulatory process for ExoPTEN

2024-02-02 16:14 ET - News Release

Dr. Lior Shaltiel reports


Nurexone Biologic Inc. has initiated the orphan drug designation process with the European Medicines Agency (EMA) for its groundbreaking ExoPTEN product, currently in development for patients with acute spinal cord injury. This strategic move follows the recent grant of orphan drug designation by the United States Food and Drug Administration (FDA) for ExoPTEN.

Dr. Ina Sarel, head of CMC, quality and regulation at Nurexone Biologic, expressed enthusiasm about the development, stating: "Embarking on the European orphan drug designation process marks a crucial milestone in our mission to bring life-changing treatments to patients in need around the world."

The recent FDA approval of orphan drug designation for ExoPTEN in the United States underscores the potential of Nurexone Biologic's therapeutic approach in a field where treatment options are limited, and it is expected to yield significant market benefits for the company. The initiation of the European orphan drug designation process represents a strategic move to broaden the reach of this promising treatment globally.

Orphan drug designation is granted to therapies addressing rare diseases, providing incentives to encourage the development of treatments for conditions affecting a small number of patients. Notable benefits of orphan drug designation in Europe include 10 years of market exclusivity in the European Union, fee reduction, financial incentives and extended market protection.

To expedite the application process, the company has enlisted the expertise of an external consultant to secure European orphan drug designation.

About Nurexone Biologic Inc.

Nurexone Biologic is a TSX Venture Exchange-listed pharmaceutical company developing a platform for biologically guided ExoTherapy using exosomes as a next-generation drug delivery system. The company's first product, ExoPTEN, is aimed at neural regeneration and recovery in patients who have suffered acute spinal cord injury. Notably, ExoPTEN has received orphan drug designation by the Food and Drug Administration highlighting its potential significance for these patients. The company holds an exclusive worldwide licence from the Technion and Tel Aviv University for the development and commercialization of the technology.

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