On December 16, 2022 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, reported 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 (Press release, Y-mAbs Therapeutics, DEC 16, 2022, View Source [SID1234625360]).

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"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.