EMA MAA Validation Follows Submission of NDA for Lenacapavir to the U.S. FDA – – If Authorized, Lenacapavir Would be the First Capsid Inhibitor and the Only HIV-1 Treatment Option Administered Twice Yearly – Gilead Sciences, Inc. today announced that the company’s Marketing Authorization Application for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor, has been fully validated and is now .