Gilead Sciences (GILD) got what it wanted and maybe more from the two Phase III studies of its next-generation HIV drug TAF.
I previewed the importance of TAF to GIlead as a superior replacement to its stalwart but patent-challenged HIV drug Viread on Monday. This morning, the company announced positive results with the TAF-containing regimen (Stribild-TAF) demonstrating statistical non-inferiority to Stribild on the primary endpoint of HIV viral load reduction.
Better yet, TAF came out superior on two key safety endpoints measuring kidney function and bone mineral density compared to Viread.
Based on the data from the two studies, Gilead intends to seek regulatory approval for TAF in the U.S. and Europe during the fourth quarter.
Gilead shares were up about 1.5% to $106.95 in Wednesday trading. The stock's performance this year has been phenomenal, up 42% for the year to date and over 70% for the past 52 weeks.