Shares of Gilead Sciences (NASDAQ: NASDAQ:GILD) declined 4% on Tuesday after the company announced that the FDA placed clinical holds on studies of several of its HIV drugs.
The FDA placed a clinical hold on Gilead’s HIV treatment trials of GS-1720 (an investigational integrase strand transfer inhibitor) and/or GS-4182 (an investigational capsid inhibitor). The clinical hold was due to the identification of a safety signal of decreases in CD4+T-cell (CD4) and absolute lymphocyte counts in a subset of participants receiving the combination of GS-1720 and GS-4182.
"We intend to investigate and pursue the potential of both agents and are committed to working with regulatory authorities to resolve the issues underlying the clinical hold," the company said in a press release. "The safety of individuals taking Gilead medicines is our foremost priority and we remain focused on pursuing advances to improve outcomes and expand options for people living with HIV."