Gilead is licensing once-yearly lenacapavir before Phase 3 results. Why take the manufacturing risk now?
Gilead Sciences has expanded royalty-free licensing agreements with six generic manufacturers to cover investigational once-yearly lenacapavir for HIV prevention while the Phase 3 PURPOSE 365 study is still underway. The decision deliberately moves manufacturing and access planning ahead of regulatory certainty, potentially shortening the years-long delay that has historically separated pharmaceutical innovation from broad availability