Y-mAbs Provides Regulatory Update on Omburtamab for the Treatment of Patients with Neuroblastoma
October 05 2020 - 4:01PM
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 Y-mAbs has received a Refusal to File letter from the U.S.
Food and Drug Administration (“FDA”) regarding the Biologics
License Application (“BLA”) for omburtamab for the treatment of
pediatric patients with CNS/leptomeningeal metastasis from
neuroblastoma, which was submitted in August 2020.
Upon preliminary review, the FDA determined that
certain parts of the Chemistry, Manufacturing and Control (“CMC”)
module and the Clinical module of the BLA require further detail.
No additional non-clinical data have been requested or are
required.
Y-mAbs is confident that it can address all
points raised by the FDA, including providing the requested
additional CMC information and supplementary data from Study 101,
which will include tumor response data from patients with evaluable
disease among the first 24 patients included in the protocol.
The Company will request a Type A meeting with
the FDA as soon as possible, and plans to work in close dialog with
the Agency in order to amend the BLA with the goal of resubmitting
the BLA before the end of 2020.
Investor Call
and Webcast
Y-mAbs will hold an investor conference call to
discuss this update on October 6, 2020 at 9:00 a.m. EDT.
Investors are invited to listen to a live
webcast of the call by dialing 877-407-0792 in the U.S. or
201-689-8263 for international callers, Conference ID: 13711563. To
access a live webcast of the update, please use the following link:
http://public.viavid.com/index.php?id=141792.
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 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 -
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.
“Y-mAbs” is a registered trademark 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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