The CHMP has Adopted a Negative Opinion for Omburtamab for the Treatment of CNS/LM Metastasis from Neuroblastoma in Europe
December 16 2022 - 4:01PM
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 European Committee for Medicinal Products for Human use
(“CHMP”) has adopted a negative opinion recommending a refusal of
the marketing authorization for omburtamab for the treatment of
CNS/leptomeningeal metastasis from neuroblastoma in Europe.
"This recommendation by the CHMP is disappointing given the
significant unmet medical need, which exists for patients with
CNS/LM neuroblastoma who have no approved therapies available. CHMP
considered that it was not possible to conclude on the
effectiveness of omburtamab as the main study did not have a
randomized comparator. The company does not believe it is feasible
to conduct a randomized study in a life-threatening disease where
no other approved therapy is available to these children," said
Thomas Gad, founder, President and Interim Chief Executive Officer.
"Our focus is now on assessing the implications of the negative
opinion and our plans for the omburtamab program.”
Researchers at Memorial Sloan Kettering Cancer Center (“MSK”)
developed omburtamab, which is exclusively licensed by MSK to
Y-mAbs. MSK has institutional financial interests 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 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 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, our
expectations with respect to the omburtanab program and the
clinical profile of omburtamab; the development and
commercialization of our products, product candidates and product
pipeline; ; 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’’
“goal”, “aim”, 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
COVID-19 pandemic; risks associated with the conflict between
Russia and Ukraine and sanctions related thereto, macroeconomic
conditions, including inflation and uncertain global credit and
capital markets; 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 the Securities and Exchange
Commission (the “SEC”) and in our other SEC filings, including our
Quarterly Reports on Form 10-Q for the quarters ended March 31,
2022, June 30, 2022, and September 30, 2022 as well as 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
except as required by law.
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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