Takeda's Maribavir US Application For Post-Transplant CMV Infection Under Review

The FDA has accepted for review Takeda Pharmaceutical Co Ltd's (NYSE TAK) marketing application for maribavir for cytomegalovirus (CMV) Infection.
The application under priority review is seeking maribavir approval CMV infection in those that are refractory with or without resistance (R/R), in solid organ transplant (SOT), or hematopoietic cell transplant (HCT) recipients.
It is an inflection year for Takeda's pipeline, with up to six regulatory submissions and four potential approvals anticipated by the end of the fiscal year 2021.
Maribavir is Takeda's fourth new molecular entity accepted for regulatory review in six months.
Price Action: TAK shares are up 0.98% at $17.49 in the premarket session on the last check Friday.
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