Y-mAbs Announces Data to be Presented at the 55th Congress of the International Society of Pediatric Oncology
21 Septiembre 2023 - 3:05PM
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
the acceptance of four abstracts at the 55th Congress of the
International Society of Pediatric Oncology ("SIOP") to be held
October 11-14, 2023 in Ottawa, Canada.
The abstracts include the following poster presentations of
DANYELZA® (naxitamab-gqgk), the Company's approved therapy for the
treatment of pediatric patients with relapsed or refractory
high-risk neuroblastoma, which is currently also being evaluated
for the treatment of osteosarcoma and other GD2-positive
tumors:
- "Efficacy of Naxitamab in Refractory High-risk Neuroblastoma"
(P148 / #1060)
- "Naxitamab Efficacy and Safety in Patients Treated With and
Without Steroid Premedication" (P149 / #1609)
- "Efficacy and Safety of Naxitamab in Patient Subgroups with
High-Risk Neuroblastoma" (P150 / #1641)
The poster presentations will be available for viewing on
October 11, 2023 between 7:00 a.m. and 7:00 p.m. ET. The full
abstracts are available on the SIOP website here,
https://siop-congress.org.
In addition, the Company's abstract titled, "Characterization of
Onset and Resolution of Adverse Events in Patients Treated with
Naxitamab in Trial 201," has been accepted for online
publication.
Researchers at Memorial Sloan Kettering Cancer Center (MSK)
developed DANYELZA® (naxitamab-gqgk), which is exclusively licensed
by MSK to Y-mAbs. MSK has institutional financial interests in the
compound and Y-mAbs.
About DANYELZA®
(naxitamab-gqgk)DANYELZA® (naxitamab-gqgk) is indicated,
in combination with granulocyte-macrophage colony-stimulating
factor ("GM-CSF"), for the treatment of pediatric patients 1 year
of age and older and adult patients with relapsed or refractory
high-risk neuroblastoma in the bone or bone marrow who have
demonstrated a partial response, minor response, or stable disease
to prior therapy. This indication was approved under accelerated
approval based on overall response rate and duration of response.
Continued approval for this indication may be contingent upon
verification and description of clinical benefits in a confirmatory
trial. DANYELZA® includes a Boxed Warning for serious
infusion-related reactions, such as cardiac arrest and anaphylaxis,
and neurotoxicity, such as severe neuropathic pain and transverse
myelitis. See full Prescribing Information for complete Boxed
Warning and other important safety information.
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,
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 Section 27A of
the Securities Act of 1933 and Section 21E of the Securities
Exchange Act of 1934. Such statements include, but are not limited
to, statements about our business model, including the Company's
plans and strategies, development, commercialization and product
distribution plans; expectations with respect to our products and
product candidates, including the potential of DANYELZA and the
potential benefits thereof; 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", "guidance," 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; the
risks that actual results of our restructuring plan and revised
business plan will not be as expected; 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 macroeconomic conditions, including the conflict
between Russia and Ukraine and sanctions related thereto,
inflation, increased interest rates, uncertain global credit and
capital markets and disruptions in banking systems; and other risks
and uncertainties affecting the Company including those described
in the "Risk Factors" section included in the Company's Annual
Report on Form 10-K for the fiscal year ending December 31, 2022,
the Company's Quarterly Report on Form 10-Q for the quarter ended
March 31, 2023, the Company's Quarterly Report on Form 10-Q for the
quarter ended June 30, 2023 and future filings and reports by the
Company. 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.
Investor Contact:
Courtney DuganVP, Head of Investor Relationscdu@ymabs.com
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