Biotech Stocks Facing FDA Decision In August


AbbVie Inc.’s (ABBV) Maviret for the treatment of all major genotypes (GT1-6) of chronic hepatitis C virus is under priority review by the FDA.

Maviret is a fixed-dose combination of two direct acting-antivirals, Glecaprevir and Pibrentasvir, dosed once-daily as three oral tablets. Glecaprevir was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (ENTA).

Although the PDUFA date has not been disclosed, we estimate that the decision is likely to be announced by August 2, 2017, based on the review timeline of 6 months for priority review.

Maviret was approved in the European Union on July 28, 2017.

ABBV closed Friday's (July 28) trading at $70.44, down 1.80%.