Y-mAbs Announces Completion of Pre-BLA Meeting with FDA for Omburtamab
February 11 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 it recently completed a Pre-Biologics License Application
(“pre-BLA”) meeting with the U.S. Food and Drug Administration
(“FDA”) regarding a potential pathway for FDA approval of
omburtamab for the treatment of patients with CNS/leptomeningeal
metastases from neuroblastoma. The Company expects to resubmit the
BLA for omburtamab by the end of the first quarter 2022.
A data readout from a single-center clinical
study (Study 03-133) of omburtamab conducted at Memorial Sloan
Kettering (“MSK”), where 107 evaluable patients with
CNS/leptomeningeal metastases from neuroblastoma received up to two
doses of radiolabeled omburtamab, showed that patients had a median
survival of 50.0 months, with the final median not yet being
reached. The Company intends to submit the complete clinical data
package in the BLA and announce the data later this year.
“We are pleased with the outcome of the pre-BLA
meeting for omburtamab providing a clear regulatory path forward
for the resubmission of the BLA. We believe omburtamab has the
potential to make a meaningful impact in addressing a substantial
unmet medical need for children suffering from high-risk
neuroblastoma brain tumors and may potentially add an important
treatment option to doctors and families facing this diagnosis,”
said Thomas Gad, founder, Chairman and President.
Dr. Claus Moller, Chief Executive Officer
further notes, “We believe that we can resubmit the omburtamab BLA
by the end of the first quarter 2022. We have been working closely
with the agency to get to this point, and we will be applying for
full approval. I am very grateful to the FDA and my team for the
high-level constructive collaboration that has been exercised to
get to this pivotal point.”
Researchers at MSK developed omburtamab, which
is exclusively licensed by MSK to Y-mAbs. As a result of the
licensing arrangement, MSK has institutional financial interest
related to the compound.
About Y-mAbs
Y-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 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 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
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 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
Y mAbs Therapeutics (NASDAQ:YMAB)
Historical Stock Chart
From Aug 2024 to Sep 2024
Y mAbs Therapeutics (NASDAQ:YMAB)
Historical Stock Chart
From Sep 2023 to Sep 2024