NurExone Biologic Receives FDA Orphan-Drug Designation, Accelerating Development of ExoPTEN therapy for Acute Spinal Cord Injury Treatment
30 10월 2023 - 10:20PM
NurExone Biologic Inc. (TSXV: NRX) (FSE: J90) (NRX.V) (the
“Company” or “NurExone”), a pioneering biotechnology company, is
thrilled to announce that the U.S. Food and Drug Administration
(FDA) has granted Orphan-Drug Designation (ODD) for its ExoPTEN
therapy, recognizing the potential of this groundbreaking
regenerative therapy for acute spinal cord injury, a condition
where effective treatments are limitedi.
The orphan drug designation provides significant
benefits to pharmaceutical companies developing drugs for rare
diseases, i.e. those impacting fewer than 200,000 people in the
United Statesii. These 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.
Earning orphan-drug designation is a significant
milestone for the Company. The designation covers the use of
mesenchymal stem cell (MSC) derived small extracellular vesicles
(EVs) loaded with short and modified interfering RNA (siRNA)
targeting the phosphatase and tensin homolog (PTEN) protein for
acute spinal cord injury, as implemented in the Company’s ExoPTEN
drug under development.
“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,” said Dr. Shaltiel, CEO of NurExone Biologic,
Ltd.
About NurExone Biologic
Inc.
NurExone Biologic Inc. is a TSXV listed
pharmaceutical company that is developing a platform for
biologically-guided ExoTherapy to be delivered, non-invasively, to
patients who suffered traumatic spinal cord injuries. ExoTherapy
was conceptually demonstrated in animal studies at the Technion,
Israel Institute of Technology. Via its fully-owned subsidiary,
NurExone Biologic Ltd, NurExone is translating the treatment to
humans, and the Company holds an exclusive worldwide license from
the Technion and Tel Aviv University for the development and
commercialization of the technology.
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. 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 Company’s ExoTherapy drug, ExoPTEN and the potential
benefits to the Company of the orphan-drug designation of ExoPTEN.
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 our ability to retain key personnel, our ability to
continue investing in research and development, our ability to
secure available funding and to continue as a going concern, our
ability to meet the post-approval requirements in respect of the
orphan-drug designation, the general business and economic
conditions of the industries and countries in which we operate,
that the Company’s operations in Israel will not be material
disrupted by unrest in Israel and the Israel-Hamas War, our ability
to execute on our business strategy, that there will be certain
amount of demand for the Company’s potential product, inflation
will remain stable, and that the results of our studies reflect
results that can be extrapolated.
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 not being able to
demonstrate clinical superiority of its ExoTherapy drug, ExoPTEN,
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, the effect of the Israel-Hamas War on the
Company’s operations 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.
i https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=940823ii https://www.fda.gov/patients/rare-diseases-fda
NurExone Biologic (TG:J90)
과거 데이터 주식 차트
부터 5월(5) 2024 으로 6월(6) 2024
NurExone Biologic (TG:J90)
과거 데이터 주식 차트
부터 6월(6) 2023 으로 6월(6) 2024