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Biotech Stocks Facing FDA Decision In November 2021

Takeda Pharmaceutical
Takeda Pharmaceutical

Takeda Pharmaceutical Company Limited’s (TAK) Maribavir, which is under priority review by the FDA, awaits the decision on Nov.21, 2021.

Maribavir is proposed for the treatment of cytomegalovirus infection in those that are refractory with or without resistance (R/R), in solid organ transplant (SOT) or hematopoietic cell transplant (HCT) recipients.

Cytomegalovirus infection (CMV) is one of the most common viral infections experienced by transplant recipients, and generic antivirals like Ganciclovir and Valganciclovir are some of the treatment options.

If approved, Maribavir will be the first and only treatment indicated for post-transplant CMV infection in those that are refractory, with or without resistance.

On Oct.7, 2021, an FDA panel recommended approval of Maribavir for the proposed indication. The FDA usually follows the recommendations of its advisory panels, although it is not required to do so.

TAK closed Thursday’s trading at $14.11, up 2.10%.