April 12 Quick Takes: FDA lifts clinical hold on magrolimab studies

Gilead Sciences Inc. (NASDAQ:GILD) is restarting enrollment of myelodysplastic syndrome (MDS) and acute myelogenous leukemia (AML) patients in its magrolimab studies after FDA lifted the partial clinical hold it placed on them in January. The pharma had been investigating the combination of magrolimab and azacitidine to treat MDS and AML, but FDA halted new enrollment due to an “apparent imbalance” in investigator-reported suspected unexpected serious adverse reactions between study arms. A partial clinical hold affecting studies evaluating magrolimab in diffuse large B cell lymphoma and multiple myeloma remains in place. Gilead gained the potential first-in-class mAb against CD47 and a macrophage checkpoint inhibitor via its $4.9 billion takeout of Forty Seven Inc. in March 2020.

Myovant Sciences GmbH (NYSE:MYOV) fell $3.48 (25%) to $10.39 after it said FDA identified “deficiencies” in the sNDA for Myfembree relugolix combination which the company is jointly developing and commercializing with  Pfizer Inc. (NYSE:PFE). According to the company, FDA said the deficiencies prevent discussion of labeling and/or post-marketing requirements but did not provide more details. The sNDA is for Myfembree to manage moderate to severe pain associated with endometriosis, and has a PDUFA date of May 6. ...