(TAK), (YMAB) – Y-mAbs Gains Regulatory Approval in Israel for Neuroblastoma Candidate
The Israeli Ministry of Health has approved Y-mAbs Therapeutics’ YMAB main 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 bone or bone marrow .
Thomas Gad, Acting President and CEO, said, “DANYELZA’s regulatory approval in Israel represents our first marketing authorization outside of the United States and is an important milestone for our collaboration with Takeda and, more importantly, for the pediatric patients we serve. The approval in Israel further demonstrates our commitment to extending 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 pleased with the approval of DANYELZA in Israel. This registration, following the accelerated reimbursement of the product last December by the Israeli Ministry of Health, allowing Takeda and Y-mAbs to offer an innovative new treatment to pediatric patients with neuroblastoma in Israel, is in line with Takeda’s vision to better health and a brighter future for every patient in the world. »
DANYELZA is being developed in combination with granulocyte-macrophage colony-stimulating factor, in pediatric patients aged one year and older and in adult patients with relapsed or refractory high-risk neuroblastoma of bone or bone marrow who have demonstrated partial response, minor response, or stable disease to prior therapy.
Y-mAbs is expected to market DANYELZA through Takeda Israel, under the exclusive license and distribution agreement.
Price Action: Takeda shares are trading around 13.81 on Tuesday at press time.