Nurexone Biologic Initiates European Orphan Drug Designation Process Following U.S. Grant
02 Février 2024 - 10:05PM
NurExone Biologic Inc. (TSXV: NRX) (FSE: J90) (NRX.V), known as
"NurExone," is pleased to announce the initiation of 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 U.S.
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 ten 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 Inc. is a TSXV listed
pharmaceutical company that is developing a platform for
biologically-guided exosome-based therapies to be delivered,
non-invasively, to patients who have suffered Central Nervous
System injuries. The company’s first product, ExoPTEN for acute
spinal cord injury, was proven to recover motor function in 75% of
laboratory rats when administered intranasally. ExoPTEN has
received Orphan Drug Designation from the FDA with first-in-human
expected in 2025. The NurExone platform technology is expected to
offer novel solutions to drug companies interested in noninvasive
targeted drug delivery for other indications.
For additional information, please
visit www.nurexone.com or follow NurExone
on LinkedIn, Twitter, Facebook, or YouTube.
For more information, please contact:
Dr. Lior ShaltielChief Executive Officer and DirectorPhone:
+972-52-4803034Email: info@nurexone.com
Thesis Capital Inc.Investment Relation -
CanadaPhone: +1 905-347-5569Email: IR@nurexone.com
Dr. Eva ReuterInvestment Relation -
GermanyPhone: +49-69-1532-5857Email: e.reuter@dr-reuter.eu
FORWARD-LOOKING STATEMENTS
This press release contains certain
“forward-looking statements”, that reflect the Company’s current
expectations and projections about its future results and
regulatory pathway. Wherever possible, words such as “may”, “will”,
“should”, “could”, “expect”, “plan”, “intend”, “anticipate”,
“believe”, “estimate”, “predict” or “potential” or the negative or
other variations of these words, or similar words or phrases, have
been used to identify these forward-looking statements.
Forward-looking statements in this press release include, but are
not limited to, statements relating to the initiation of the Orphan
Drug Designation process with the European Medicines Agency and the
possible benefits relating thereto. These statements reflect
management’s current beliefs and are based on information currently
available to management as at the date hereof.
In developing the forward-looking statements in
this press release, we have applied several material assumptions,
including the general business and economic conditions of the
industries and countries in which we operate, the general market
conditions, our ability to meet the Orphan Drug Designation
requirements of the European Medicines Agency and our ability to
exploit the benefits related thereto.
Forward-looking statements involve significant
risk, uncertainties and assumptions. Many factors could cause
actual results, performance or achievements to differ materially
from the results discussed or implied in the forward-looking
statements. These risks and uncertainties include, but are not
limited to, risks related to the Company’s early stage of
development, lack of revenues to date, government regulation,
market acceptance for its products, rapid technological change,
dependence on key personnel, protection of the Company’s
intellectual property, dependence on the Company’s strategic
partners and the risks discussed under the heading “Risk Factors”
on pages 29 to 36 of the Company’s Annual Information Form dated
March 30, 2023, a copy of which is available under the Company’s
SEDAR+ profile at www.sedarplus.ca. These factors should be
considered carefully and readers should not place undue reliance on
the forward-looking statements. Although the forward-looking
statements contained in this press release are based upon what
management believes to be reasonable assumptions, the Company
cannot assure readers that actual results will be consistent with
these forward-looking statements. These forward-looking statements
are made as of the date of this press release, and the Company
assumes no obligation to update or revise them to reflect new
events or circumstances, except as required by law.
Neither TSX Venture Exchange nor its Regulation
Services Provider (as that term is defined in the policies of the
TSX Venture Exchange) accepts responsibility for the adequacy or
accuracy of this release.
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