The FDA has placed a clinical hold on Gilead Sciences' investigational HIV trials combining GS-1720 and GS-4182 after observing declines in CD4+ T-cell and absolute lymphocyte counts in some participants. The hold affects multiple Phase 1, 2, and 3 trials, but does not impact Gilead's other long-acting HIV regimens. GILD is currently trading down 2.02 percent following the announcement.
The U.S. Food and Drug Administration has placed a clinical hold on Gilead Sciences' (GILD) investigational HIV combination therapy, involving GS-1720 and GS-4182, due to an identified safety signal: declines in CD4+ T-cell and absolute lymphocyte counts in some participants. This regulatory action affects two Phase 2/3 WONDERS studies and three Phase 1 trials, pausing the progression of these specific unapproved agents. Notably, this hold does not impact Gilead's other long-acting oral or injectable HIV regimens under clinical or preclinical evaluation, indicating the issue is currently confined to this particular investigational combination. Gilead is reportedly collaborating with regulators to address the findings and determine a path forward. The market reacted negatively to this development, with GILD's stock price declining by $2.28, or 2.02 percent, to $110.72 on the Nasdaq, reflecting concerns over this setback in its drug pipeline.
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