Y-mAbs Gets Regulatory Approval In Israel For Neuroblastoma Candidate

The Israeli Ministry of Health has approved Y-mAbs Therapeutics’ YMAB lead drug DANYELZA in combination with granulocyte-macrophage colony-stimulating factor for pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow.

Thomas Gad, President, and Interim Chief Executive Officer, commented: "The regulatory approval of DANYELZA in Israel represents our first marketing authorization outside of the U.S. and is a milestone for our collaboration with Takeda and more importantly for the pediatric patients we are dedicated to serving. he approval in Israel further demonstrates our commitment to expanding the reach of our commercial stage products internationally to patients with unmet medical needs.”

Arie Kramer, General Manager of Takeda Israel, said, "We are extremely excited by the approval of DANYELZA in Israel, This registration, following the expedited reimbursement of the product last December by the Israeli Ministry of Health, allowing Takeda and Y-mAbs to offer a new innovative treatment for pediatric neuroblastoma patients in Israel, is in alignment with Takeda's vision of Better Health and Brighter Future to every patient in the world."

DANYELZA is developed in combination with granulocyte-macrophage colony-stimulating factor, 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.

Y-mAbs is expected to commercialize DANYELZA by Takeda Israel, under the exclusive license and distribution agreement.

Price Action : Takeda shares are trading around 13.81 on Tuesday at the time of publication.