FDA Halts Gilead's HIV Trials Over Safety Signal

(RTTNews) - The U.S. Food and Drug Administration Tuesday announced that it has placed a clinical hold on Gilead Sciences' (GILD) investigational HIV trials combining GS-1720 and GS-4182.

This action follows identification of a safety signal declines in CD4+ T-cell and absolute lymphocyte counts—in some participants receiving the combo. Trial investigators have been notified. Neither agent is approved anywhere, and Gilead is working with regulators to address the findings and determine a path forward.

This hold affects two Phase 2/3 WONDERS studies and three Phase 1 trials but does not impact Gilead's other long-acting oral or injectable HIV regimens under clinical or preclinical evaluation. Patient safety remains Gilead's top priority.

GILD is currently trading at $110.72, down $2.28 or 2.02 percent on the Nasdaq.