Gilead Sciences Inc.’s GILD, +0.03% once-a-day HIV regimen has been approved by the Food and Drug Administration, the company said Wednesday afternoon. The regimen, Biktarvy, is intended for HIV patients who are new to treatment and will cost $35,859, similar to other single-tablet HIV therapies, said Mizuho analyst Salim Syed. The approval happened a few days earlier than expected, and the safety label for the product is clean, he said. Biktarvy is expected to become a “gold standard” HIV regimen for patients new to treatment because it has a high barrier to resistance, no liver toxicity issues, few potential drug-drug interactions, a small pill size and a rapid start to therapy, said RBC Capital Markets analyst Brian Abrahams. Gilead shares rose 4.5% in extremely heavy Wednesday afternoon trade. Shares have surged 14.7% over the last three months, compared with a 4.6% rise in the S&P 500 SPX, -3.75% and a 5.8% rise in the Dow Jones Industrial Average DJIA, -4.15%

By Emma Court

Source: https://www.marketwatch.com/story/gileads-once-a-day-hiv-regimen-has-been-approved-by-fda-2018-02-07