Y-mAbs’ DANYELZA® (naxitamab-gqgk) for the Treatment of High-Risk Neuroblastoma approved in Brazil
May 23 2023 - 9:00AM
Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq:
YMAB) a commercial-stage biopharmaceutical company focused on the
development and commercialization of novel, antibody-based
therapeutic products for the treatment of cancer, today announced
that the Brazilian Health Regulatory Agency, Agência Nacional de
Vigilância Sanitária (“Anvisa”) has granted marketing authorization
for DANYELZA (naxitamab-gqgk) 40mg/10mL injection. DANYELZA will be
marketed in Brazil by Y-mAbs’ partner Adium Pharma S.A. (“Adium”).
DANYELZA is a recombinant humanized, monoclonal
antibody that targets the ganglioside GD2, which is highly
expressed in various neuroectoderm-derived tumors and sarcomas.
DANYELZA is administered to patients three times in a week and the
treatment is repeated every four weeks.
“Today is an important day for children living
with refractory/relapsed high-risk neuroblastoma in Brazil. It’s
very exciting to see this treatment approved, creating access to
DANYELZA in Brazil from the joint efforts by our partner Adium and
the development team at Y-mAbs. We continue to focus on expansion
of DANYELZA in other jurisdictions, working to provide access to
children living with refractory or relapsed neuroblastoma,” said
Thomas Gad, founder, President and Interim CEO.
Researchers at Memorial Sloan Kettering Cancer
Center (“MSK”) developed DANYELZA, which is exclusively
licensed by MSK to Y-mAbs. MSK has institutional financial
interests related to the compound and Y-mAbs.
About DANYELZA®
(naxitamab-gqgk)
In the United States, DANYELZA® (naxitamab-gqgk)
is indicated, in combination with granulocyte-macrophage
colony-stimulating factor (“GM-CSF”), for the treatment of
pediatric patients 1 year of age and older and adult patients with
relapsed or refractory high-risk neuroblastoma in the bone or bone
marrow who have demonstrated a partial response, minor response, or
stable disease to prior therapy. This indication was approved by
the US Food and Drug Administration (“FDA”) under accelerated
approval based on overall response rate and duration of response.
Continued approval for this indication may be contingent upon
verification and description of clinical benefits in a confirmatory
trial. DANYELZA® includes a Boxed Warning for serious
infusion-related reactions, such as cardiac arrest and anaphylaxis,
and neurotoxicity, such as severe neuropathic pain and transverse
myelitis. See full Prescribing Information
(https://labeling.ymabs.com/danyelza) for complete Boxed Warning
and other important safety information.
About Y-mAbs
Y-mAbs is a commercial-stage biopharmaceutical
company focused on the development and commercialization of novel,
antibody-based therapeutic cancer products. In addition to
conventional antibodies, the Company’s technologies include
bispecific antibodies generated using the Y-BiClone platform and
the SADA platform. The Company’s broad and advanced product
pipeline includes one FDA-approved product, DANYELZA®
(naxitamab-gqgk), which targets tumors that express GD2, and one
product candidate at the registration-stage, OMBLASTYS®
(omburtamab), which targets tumors that express B7-H3.
Forward-Looking Statements
Statements in this press release about future
expectations, plans and prospects, as well as any other statements
regarding matters that are not historical facts, may constitute
“forward-looking statements” within the meaning of The Private
Securities Litigation Reform Act of 1995. Such statements include,
but are not limited to, statements with respect to the Company’s
product, product candidates and pipeline, including with respect to
the commercialization effortts to expand access to DANYELZA;
statements with respect to the benefits of DANYELZA; statements
with respect to expected marketing of DANYELZA in Brazil; and other
statements that are not historical facts. Words such as
‘‘anticipate,’’ ‘‘believe,’’ “contemplate,” ‘‘continue,’’
‘‘could,’’ ‘‘estimate,’’ ‘‘expect,’’ “hope,” ‘‘intend,’’ ‘‘may,’’
‘‘might,’’ ‘‘plan,’’ ‘‘potential,’’ ‘‘predict,’’ ‘‘project,’’
‘‘should,’’ ‘‘target,’’ “will”, ‘‘would’’ and similar expressions
are intended to identify forward-looking statements, although not
all forward-looking statements contain these identifying words. Our
product candidates and related technologies are novel approaches to
cancer treatment that present significant challenges. Actual
results may differ materially from those indicated by such
forward-looking statements as a result of various factors,
including but not limited to: risks associated with our financial
condition and need for additional capital; the risks that actual
results of our restructuring plan and revised business plan will
not be as expected; risks associated with our development work;
cost and success of our product development activities and clinical
trials; the risks of delay in the timing of our regulatory
submissions or failure to receive approval of our drug candidates;
the risks related to commercializing any approved pharmaceutical
product including the rate and degree of market acceptance of our
product candidates; development of our sales and marketing
capabilities and risks associated with failure to obtain sufficient
reimbursement for our products; the risks related to our dependence
on third parties including for conduct of clinical testing and
product manufacture; our inability to enter into partnerships; the
risks related to government regulation; risks related to market
approval; risks associated with protection of our intellectual
property rights; risks related to employee matters and managing
growth; risks related to our common stock, risks associated with
the COVID-19 pandemic; risks associated with the conflict
between Russia and Ukraine and sanctions
related thereto; including inflation and uncertain global credit
and capital markets; and other risks and uncertainties affecting
the Company including those described in the “Risk Factors” section
included in our Annual Report on Form 10-K for the year ended
December 31, 2022 and our Quarterly Report on Form 10-Q for the
quarter ended March 31, 2023 filed with the SEC and in our other
SEC filings. Any forward-looking statements contained in this press
release speak only as of the date hereof, and the Company
undertakes no obligation to update any forward-looking statement,
whether as a result of new information, future events or
otherwise.
DANYELZA®, OMBLASTYS® and Y-mAbs® are registered
trademarks of Y-mAbs Therapeutics, Inc.
Contact:
Y-mAbs Therapeutics, Inc. 230 Park Avenue, Suite 3350New York,
NY 10169USA
+1 646 885 8505
E-mail: info@ymabs.com
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