Nov. 25 Quick Takes: FDA approves Y-mAbs’ Danyelza; plus NIH’s ACTT-4; COVAXX, Urovant, SomaLogic, Eluminex and Liquidia

FDA approves Y-mAbs’ Danyelza for neuroblastoma
Shares of Y-mAbs Therapeutics Inc. (NASDAQ:YMAB) were up 17% in after-hours trading Wednesday after FDA granted accelerated approval to Danyelza naxitamab-gqgk plus GM-CSF to treat relapsed or refractory high-risk neuroblastoma. The company said it has already begun the confirmatory trial that could lead to full approval of the humanized mAb against GD2. Y-mAbs licensed Danyelza from Memorial Sloan Kettering Cancer Center, which retains a financial interest in the product.

NIAID to compare two immune modulators in ACTT-4
NIH’s National Institute of Allergy and Infectious Diseases said it has begun enrollment of up to 1,500 hospitalized COVID-19 patients requiring supplemental oxygen in ACTT-4. Patients in the adaptive trial will receive Veklury remdesivir from  Gilead Sciences Inc. (NASDAQ:GILD) in combination with Olumiant baricitinib from Eli Lilly and Co. (NYSE:LLY) and Incyte Corp. (NASDAQ:INCY) or dexamethasone. Olumiant shortened recovery time in ACTT-2 and dexamethasone reduced mortality in COVID-19 patients in the U.K. RECOVERY trial...