NEW YORK, Oct. 28, 2022 (GLOBE NEWSWIRE) — Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical firm targeted on the event and commercialization of novel, antibody-based therapeutic merchandise for the remedy of most cancers, at present introduced the end result of the assembly of the U.S. Food and Drug Administration (“FDA”) Oncologic Drugs Advisory Committee (“ODAC”), which reviewed investigational 131I-omburtamab (“omburtamab”) for the remedy of CNS/leptomeningeal metastasis from neuroblastoma. The committee voted 16 to 0 that the Company had not supplied adequate proof to conclude that omburtamab improves general survival.
“We are disappointed by the outcome of today’s meeting, as patients with CNS/leptomeningeal metastasis from neuroblastoma are in need of effective and safe treatment options,” mentioned Thomas Gad, President, and Interim Chief Executive Officer. “Y-mAbs is committed to working closely with the FDA on their review of the Biologic License Application (“BLA”) for omburtamab forward of their determination. We need to thank all of the sufferers, caregivers, and healthcare suppliers who participated within the research of this life-threatening situation.”
ODAC reviewed information from omburtamab’s scientific growth program with a deal with examine 03-133 (a pivotal section 1 examine) and examine 101 (a pivotal section 2 examine) in addition to the historic management group.
Y-mAbs BLA submission for omburtamab was accepted for Priority Review by the FDA on May 31, 2022, with a Prescription Drug User Fee Act (“PDUFA”) goal date of November 30, 2022. The FDA just isn’t sure by the Advisory Committee’s suggestions however usually takes the advice into consideration when making its determination.
Researchers at MSK developed omburtamab, which is completely licensed by MSK to Y-mAbs. As a outcome of this licensing association, MSK has institutional monetary pursuits within the compound.
About Y-mAbs
Y-mAbs is a commercial-stage biopharmaceutical firm targeted on the event and commercialization of novel, antibody-based therapeutic most cancers merchandise. In addition to traditional antibodies, the Company’s applied sciences embody bispecific antibodies generated utilizing the Y-BiClone platform and the SADA platform. The Company’s broad and superior product pipeline contains one FDA-approved product, DANYELZA® (naxitamab-gqgk), which targets tumors that specific GD2, and one product candidate on the registration-stage, OMBLASTYS® (131I-omburtamab), which targets tumors that specific B7-H3.
Forward-Looking Statements
Statements on this press launch about future expectations, plans and prospects, in addition to some other statements relating to issues that aren’t historic details, might represent “forward-looking statements” throughout the that means of The Private Securities Litigation Reform Act of 1995. Such statements embody, however are usually not restricted to potential approval of omburtamab within the United States and the timing thereof; and different statements that aren’t historic details. Words similar to “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “hope,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will”, “would”, “goal,” “aim,” and comparable expressions are supposed to determine forward-looking statements, though not all forward-looking statements comprise these figuring out phrases. Our product candidates and associated applied sciences are novel approaches to most cancers remedy that current important challenges. Actual outcomes might differ materially from these indicated by such forward-looking statements consequently of varied components, together with however not restricted to: dangers related to our monetary situation and wish for extra capital; dangers related to our growth work; price and success of our product growth actions and scientific trials; the dangers of delay within the timing of our regulatory submissions or failure to obtain approval of our drug candidates; the dangers associated to commercializing any authorized pharmaceutical product together with the speed and diploma of market acceptance of our product candidates; growth of our gross sales and advertising capabilities and dangers related to failure to acquire adequate reimbursement for our merchandise; the dangers associated to our dependence on third events together with for conduct of scientific testing and product manufacture; our incapacity to enter into partnerships; the dangers associated to authorities regulation; dangers associated to market approval, dangers related to safety of our mental property rights; dangers associated to worker issues and managing development; dangers associated to our frequent inventory, dangers related to the COVID-19 pandemic, dangers related to the battle between Russia and Ukraine and sanctions associated thereto, macroeconomic circumstances, together with inflation and unsure world credit score and capital markets; and different dangers and uncertainties affecting the Company together with these described within the “Risk Factors” part included in our Annual Report on Form 10-Okay for the yr ended December 31, 2021, our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2022 and June 30, 2022, and in our different SEC filings. Any forward-looking statements contained on this press launch converse solely as of the date hereof, and the Company undertakes no obligation to replace any forward-looking assertion, whether or not consequently of new info, future occasions or in any other case besides as required by regulation.
DANYELZA®, OMBLASTYS® and Y-mAbs® are registered logos of Y-mAbs Therapeutics, Inc.
Contact:
Y-mAbs Therapeutics, Inc.
230 Park Avenue, Suite 3350
New York, NY 10169
USA
+1 646 885 8505
E-mail: [email protected]
