Gilead receives Complete Response Letter for lenacapavir due to vial issue
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The U.S. FDA has issued Gilead Sciences (NASDAQ:GILD) a complete response letter for its New Drug Application for its long-acting HIV medication lenacapavir over the container vial for use with the drug.
The issue, as previously brought up by the agency, relates to borosilicate glass and its compatibility with lenacapavir solution, which resulted in a clinical hold for the drug.

Gilead (GILD) said it will come up with a comprehensive plan and supporting data to use a different vial type.
Lenacapavir is an investigational long-acting HIV-1 capsid inhibitor in development for the treatment and prevention of HIV-1 infection.
Read why Seeking Alpha contributor The Value Investor considers Gilead (GILD) a hold.