Y-mAbs Announces U.S. FDA Acceptance of Biologics License Application for Danyelza™ (naxitamab) for the Treatment of Neurob...
June 02 2020 - 09:00AM
Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq:
YMAB) a late-stage clinical biopharmaceutical company focused on
the development and commercialization of novel, antibody-based
therapeutic products for the treatment of cancer, today announced
that the Biologics License Application (“BLA”) for Danyelza™
(naxitamab) for the treatment of patients with relapsed/refractory
high-risk neuroblastoma has been accepted for priority review by
the U.S. Food and Drug Administration (“FDA”). The FDA set an
action date of November 30, 2020, under the Prescription Drug User
Fee Act (“PDUFA”). The Agency also indicated in the BLA filing
communication letter that it is not currently planning to hold an
advisory committee meeting to discuss the application.
“We believe that the FDA’s acceptance of our BLA
for priority review of our first leading antibody compound,
Danyelza (naxitamab), is a significant achievement for Y-mAbs and a
crucial step forward as we anticipate that Danyelza, if approved,
can address a significant unmet medical need for children with
relapsed/refractory high-risk neuroblastoma,” stated Thomas Gad,
Founder, Chairman, President and Head of Business Development and
Strategy.
Dr. Claus Moller, Chief Executive Officer,
continued, “We look forward to working with the Agency to bring
Danyelza to appropriate patients. We are excited to move forward
and plan for a seamless commercial launch of Danyelza (naxitamab),
if approved.”
Researchers at Memorial Sloan Kettering Cancer
Center (“MSK”) developed naxitamab, which is exclusively licensed
by MSK to Y-mAbs. As a result of this licensing arrangement, MSK
has institutional financial interests in the product.
About Y-mAbs
Y-mAbs is a late-stage clinical
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 two pivotal-stage product candidates -
Danyelza (naxitamab) and omburtamab—which target tumors that
express GD2 and B7-H3, respectively.
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 about our business model and
development and commercialization plans; current and future
clinical and pre-clinical studies and our research and development
programs; 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,’’ ‘‘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; risks associated with
our development work; cost and success of our product development
activities and clinical trials; the risks of delay 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 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 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.
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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