Y-mAbs Submits Omburtamab Marketing Authorization Application to the European Medicines Agency
28 April 2021 - 6:01AM
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 Company has submitted its Marketing
Authorization Application (“MAA”) to the European Medicines Agency
for omburtamab for the treatment of pediatric patients with
CNS/leptomeningeal metastasis from neuroblastoma. Omburtamab is an
investigational, monoclonal antibody that targets B7-H3 and is
radiolabeled before intraventricular central nervous system (“CNS”)
administration. B7-H3 is an immune checkpoint molecule that is
widely expressed in tumor cells of several cancer types.
"We believe omburtamab is on track to
potentially become the first EMA approved targeted therapy for
pediatric patients with CNS/leptomeningeal metastasis from
neuroblastoma," said Thomas Gad, founder, Chairman and President at
Y-mAbs. "With this submission to EMA, Y-mAbs is continuing to
advance the omburtamab program to potentially provide access to
this innovative therapy to pediatric patients globally as quickly
as possible."
In addition, Y-mAbs recently concluded a Type B
meeting with the U.S. Food and Drug Administration (“FDA”)
regarding omburtamab and the Company continues to be in close
dialog with the FDA and maintains its aim of resubmitting the
Biologics License Application (“BLA”) to the FDA late in the second
quarter or in the third quarter of 2021.
Dr. Claus Moller, the Company’s Chief Executive
Officer, continued, “We are excited to submit the MAA for
omburtamab, and very pleased about the progress we are making. We
believe omburtamab can potentially address a significant unmet
medical need for children with CNS/leptomeningeal metastasis from
neuroblastoma. We also are continuing to work closely with the FDA
to resubmit the omburtamab BLA.”
Researchers at Memorial Sloan Kettering Cancer
Center (“MSK”) developed omburtamab, which is exclusively licensed
by MSK to Y-mAbs. As a result of this licensing arrangement, MSK
has institutional financial interest related to the compound and
Y-mAbs.
About Y-mAbsY-mAbs is a
commercial-stage biopharmaceutical company focused on the
development and commercialization of novel, antibody-based
therapeutic products for the treatment of cancer. The Company has a
broad and advanced product pipeline, including one FDA approved
product, DANYELZA® (naxitamab-gqgk), which targets tumors that
express GD2, and one pivotal-stage product candidate, omburtamab,
which targets tumors that express B7-H3.
Forward-Looking
StatementsStatements 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 about our business model and
development, commercialization and product distribution plans;
current and future clinical and pre-clinical studies and our
research and development programs; expectations related to the
timing of the initiation and completion of regulatory submissions;
regulatory, marketing and reimbursement approvals; rate and degree
of market acceptance and clinical utility as well as pricing and
reimbursement levels; retaining and hiring key employees; our
commercialization, marketing and manufacturing capabilities and
strategy; our intellectual property position and strategy;
additional product candidates and technologies; collaborations or
strategic partnerships and the potential benefits thereof;
expectations related to the use of our cash and cash equivalents,
and the need for, timing and amount of any future financing
transaction; our financial performance, including our estimates
regarding revenues, expenses, capital expenditure requirements;
developments relating to our competitors and our industry; 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,’’ ‘‘targeted,’’ “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; 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 pandemic caused by COVID-19 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, 2020, 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.
“Y-mAbs®” and “DANYELZA®” 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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