Highlights of weekly biotech stock moves
Regulatory, clinical and other milestones
AMAG Pharmaceuticals Inc. (NASDAQ:AMAG) gained $0.24 to $19.79 on Friday after partner Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) submitted a Type II variation application to EMA to expand the European label of Rienso ferumoxytol to include treatment of all adults with iron deficiency anemia who have a history of unsatisfactory oral iron therapy or cannot use oral iron. An sNDA for the indication has an Oct. 21 PDUFA date in the U.S.
Takeda markets Rienso in the EU, Switzerland, Canada and the U.S., where it is known as Feraheme, to treat iron deficiency anemia in chronic kidney disease (CKD).
AMAG gained $1.29 on the week.
Flamel Technologies S.A. (NASDAQ:FLML) was