“We continue to target regulatory submission before the end of the year in the U.S., while at the same time preparing for filings with other global regulatory authorities.”

In context

“reported from an interim analysis of the PURPOSE 1 trial in cisgender women in June, PURPOSE 2 was also stopped at the interim in September. Notably, twice yearly subcutaneous Lenacapavir significantly reduced incidence of HIV infections compared to both background HIV incidence and Truvada in the exceptionally diverse population of cisgender men and gender diverse people in a Phase 3 prevention trial. These PURPOSE 1 and 2 results demonstrated Lenacapavir's unprecedented results for HIV prevention. We look forward to sharing additional insights at the HIV Glasgow meeting next week, including persistence data from PURPOSE 1 and a deeper look into the efficacy data from PURPOSE 2. Based on these data, FDA has now granted breakthrough therapy designation for Lenacapavir for HIV prevention. We continue to target regulatory submission before the end of the year in the U.S., while at the same time preparing for filings with other global regulatory authorities. Beyond our registrational PURPOSE 1 and 2 programs, we continue to generate additional data from the Phase 2, PURPOSE 3, 4, and 5 trials in key populations across the U.S., U.K., and France. These studies are intended to contribute additional data in communities where the use of or access to prevention options have historically been challenging. Turning to our HIV treatment pipeline on Slide 19, we continue to make strong progress in developing novel regimens, including a once-daily oral regimen with two backbone therapies, Lenacapavir and Bictegravir. This novel combination has the potential to provide another effective daily oral option for people living with HIV, including the 6% to 8% of people currently on complex regimens. Recently, we completed enrollment of the Phase 3, ARTISTRY-1”