TaiMed submits BLA for HIV candidate ibalizumab

Theratechnologies Inc. (TSX:TH) said its partner TaiMed Biologics Inc. (TPEx:4147) submitted a BLA to FDA for ibalizumab (TMB-355) to treat multidrug resistant HIV-1 infection. The humanized mAb against CD4 does not require daily dosing, and would be the first antiretroviral treatment with a new mechanism of action approved by FDA in nearly a decade, Theratechnologies said.

In 2016, TaiMed granted Theratechnologies marketing rights to ibalizumab in the U.S. and Canada. TaiMed holds rights to ibalizumab under a deal with the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHBBY)...