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.
  • Related content: Benzinga's Full FDA Calendar
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