Y-mAbs Announces FDA Acceptance of Biologics License Application for OMBLASTYS® (omburtamab) for the Treatment of Neuroblastoma for Priority Review
May 31 2022 - 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 Biologics License Application (“BLA”) for OMBLASTYS®
(omburtamab) for the treatment of pediatric patients with
CNS/leptomeningeal metastasis from 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, 2022, under the
Prescription Drug User Fee Act (“PDUFA”). The Agency also indicated
in the BLA filing communication letter that it is planning to hold
an advisory committee meeting in October 2022 to discuss the
application.
“We believe that the FDA’s acceptance of our
OMBLASTYS® BLA for priority review is a significant achievement for
Y-mAbs and a crucial step forward as we anticipate that OMBLASTYS,
if approved by the FDA, can address a significant unmet medical
need for children with CNS/leptomeningeal metastasis from high-risk
neuroblastoma, where no standard therapy currently exists,
potentially adding a second rare disease product to our commercial
portfolio and without any significant further investment in our
existing commercial infrastructure. Further, OMBLASTYS® has a Rare
Pediatric Disease Designation which, if approved, will provide
Y-mAbs with a Priority Review Voucher, our second PRV, which would
further strengthen our financial position as we would seek to
monetize the OMBLASTYS® PRV,” stated Thomas Gad, Founder, President
and Interim CEO. “We look forward to working with the Agency to
bring OMBLASTYS® to the appropriate patients. We are excited to
move forward and plan for a seamless commercial launch of
OMBLASTYS®, if approved by the FDA.”
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 interests in the compound and in
Y-mAbs.
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 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,’’ ‘‘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 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 the coronavirus known as
COVID-19 and its variants such as Delta and Omicron, risks
associated with Russia’s recent invasion of Ukraine 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, 2021 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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