Gilead gets a complete response letter from FDA about the vial used to store an experimental HIV drug


Shares of Gilead Sciences Inc. GILD, -0.41% were down 1.0% in premarket trading on Tuesday after the company said it received a complete response letter from the Food and Drug Administration regarding its application for an experimental HIV drug. Gilead is seeking FDA approval for lenacapavir, a long-acting HIV-1 capsid inhibitor, for people with multi-drug resistant HIV. The FDA raised questions about the use of a specific type of vial and whether it’s compatible with the drug solution. Gilead said it will use a different type of vial. Gilead’s stock is down 3.3% over the past year, while the broader S&P 500 SPX, -0.75% has gained 14.4%.

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