FDA OKs Y-mAbs' neuroblastoma treatment

 

• Y-mAbs Therapeutics (NASDAQ:YMAB) +14.3% after-hours as the Food and Drug Administration grants accelerated approval of its Danyelza (naxitamab) cancer treatment for patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow.
• Y-mAbs says the FDA approval was supported by clinical evidence from two pivotal studies in patients with high-risk neuroblastoma with refractory or relapsed disease.
• The company expects Danyelza will be available for use in the U.S. "in the coming weeks."
• The approval was expected, and the stock price recently hit a 52-week intraday high.
• https://seekingalpha.com/news/3639563-fda-oks-y-mabs-neuroblastoma-treatment