“Later this year, we plan to share additional data that support the combination of GS-3242 with lenacapavir as a potential twice-yearly injectable treatment regimen.”

In context

“of this growth in HIV prevention, with first quarter sales growing 72% sequentially. Looking forward, with no major LOEs until 2036, Gilead Sciences, Inc.'s HIV business is poised for strong, durable growth supported by up to seven potential new HIV product launches by 2033. The first of these potential launches is bictegravir plus lenacapavir, an investigational once-daily oral regimen for virally suppressed people with HIV. This is now under priority review, and we expect an FDA decision in August. Other upcoming HIV milestones include Phase 3 updates later this quarter from the ILLAND-1 and -2 studies evaluating a potential first once-weekly oral for virally suppressed people with HIV. We shared encouraging Phase 1 data at CROI in February for a long-acting integrase inhibitor GS-3242. Later this year, we plan to share additional data that support the combination of GS-3242 with lenacapavir as a potential twice-yearly injectable treatment regimen. The time frame for potential launch is between 2031 and 2033. In oncology, first quarter Trodelvy sales were up 37% year-over-year, reflecting growing demand for Trodelvy. We anticipate regulatory decisions on extending into first-line metastatic triple-negative breast cancer in the second half of this year. Ahead of these decisions, Trodelvy has already received NCCN category 1 recommendations across the first line and is the leading ABC and second-line metastatic TNBC treatment. We are also expecting Phase 3 updates from the EVOQUE-3 trial in first-line metastatic non-small cell lung cancer and the ASCENT GYN trial in second line-plus metastatic endometrial cancer in the second half of this year. The pending acquisition of Tubulus is another significant milestone in building Gilead Scie”