“We're excited by the potential to bring bulevirtide to HDV patients in the U.S. with a potential regulatory decision in 2026.”

In context

“ng oral and injectable agents in development for a range of dosing frequencies from once weekly oral to twice yearly injectables. Our strategy has been to set up our pipeline for multiple shots on goal and then choose the best option for each dosing frequency. Notably, for our development of a twice yearly treatment regimen combining a novel integrase inhibitor with lenacapavir, we took two INSTI agents to Phase I, GS-1219 and GS-3242. Aligned with the guidance we shared at our HIV Analyst event last year, we have now chosen to prioritize the development of GS-3242 over GS-1219, and we expect to share more details on GS-3242 at a Virology Conference in 2026. On Slide 16, I'm pleased to highlight that we have completed the BLA filing for bulevirtide in chronic hepatitis delta virus or HDV. We're excited by the potential to bring bulevirtide to HDV patients in the U.S. with a potential regulatory decision in 2026. As a reminder, HDV affects approximately 2% of patients with HBV or about 40,000 people in the U.S. Patients with chronic untreated HDV infection can experience accelerated development of cirrhosis or severe scarring of the liver and have higher risk of liver cancer and potentially end-stage liver disease and failure. Beyond bulevirtide, we are also evaluating next-generation approaches to HDV treatment. Specifically, we have advanced GS-4321, a pre-S1 neutralizing antibody into Phase I clinical development. We believe GS-4321 has significant potential given its preclinical safety profile and long half-life with potentially quarterly subcutaneous dosing. Moving to Trodelvy on Slide 17. Earlier this month at the ESMO meeting, we presented detailed potentially practice-changing Phase III AS”