SShots:Omeros submitted an MAA to the EMA for narsoplimab to treat TA-TMA, with data demonstrating a 61% response rate and a 3x improvement in OS vs matched external controls; over 130 pts treated under expanded access data were also includedEMA granted Narsoplimab ODD status, and CHMP review will start mid-July under centralized…
Shots:The US FDA has accepted the Class 2 BLA resubmission of narsoplimab for the treatment of HSCT-associated thrombotic microangiopathy (TA-TMA), with PDUFA goal date assigned in late Sept 2025; EMA’s MAA filing expected by late Q2’25The BLA resubmission incl. primary set of survival analyses, showing improved OS in TA-TMA pts, along with survival…

