FDA extends PDUFA for Theratechnologies' ibalizumab to treat HIV

Theratechnologies Inc. (TSX:TH) and TaiMed Biologics Inc. (TPEx:4147) said FDA extended by 3 months the PDUFA date for ibalizumab (TMB-355) to treat multidrug-resistant HIV-1 infection. The candidate is under Priority Review. The PDUFA date is now April 3, 2018. The original date was Jan. 3, 2018 (see BioCentury, Aug. 16).

Theratechnologies said FDA extended the date to allow time to review manufacturing information submitted by TaiMed in October, which the agency constitutes a major amendment...