Gilead Sciences' (NASDAQ:GILD) Truvada-TMC278 Delayed Several Months

Gilead Sciences (NASDAQ:GILD) received a "Refuse to File" letter from the FDA concerning fixed-dose combination pill Truvada-TMC278. That should result in a delay of several months.

Jefferies noted, "the FDA requested additional information in the CMC section on new analytical methods to characterize identified degradants of the Emtriva component of Truvada."

Gilead said they'll get the information in the hands of the FDA sometime in the first quarter of 2011.

Jefferies raised their full year 2011 EPS estimate on Gilead from $4.07 to $4.13.

Jefferies Maintains Hold Rating on Gilead Sciences (GILD), which was trading at $39.45, gaining $1.29, or 3.38 percent, as of 2:36 PM EST. Jefferies raised their price target on Gilead from $41 to $42.