“This is now under priority review, and we expect an FDA decision in August.”

In context

“lso taking steps to further strengthen the company's position for the future. We are looking forward to sharing much more on our select oral, and tubulose in the coming quarters. Our HIV business grew 10% year-over-year, reflecting 7% growth for Biktarvy and an impressive 87% growth for our U.S. PrEP business. The ongoing success of the Esthugo launch is a key driver 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, Trod”