Gilead’s Investigational Single-Tablet Regimen of Bictegravir and Lenacapavir for HIV Treatment Meets Primary Endpoint in Phase 3 ARTISTRY-2 Trial

Gilead

Gilead has announced positive Phase 3 results for its investigational single-tablet regimen (STR) of bictegravir and lenacapavir (BIC/LEN) in the ARTISTRY-2 trial. The new combination met its primary endpoint, demonstrating non-inferiority to BIKTARVY in maintaining viral suppression in adults with HIV-1. This novel two-drug regimen combines the potent integrase inhibitor bictegravir with the first-in-class capsid inhibitor lenacapavir, representing a potential new, simplified treatment option for long-term HIV management.

Gilead’s Trodelvy Misses Primary Goal in First-Line Breast Cancer Study, But Hope Remains for Overall Survival

Gilead

Gilead Sciences announced its Phase 3 ASCENT-07 trial for Trodelvy® in first-line HR+/HER2-negative metastatic breast cancer did not meet its primary endpoint of progression-free survival (PFS). However, the company reported an “early trend” favoring Trodelvy for the key secondary endpoint of overall survival (OS), and the study will continue to gather more data on this measure.

Gilead Announces 2025 Q3 Results; Lifts EPS Guidance as Strong HIV Sales and Other Revenue Drive

Gilead

Gilead Sciences (GILD) reported strong Q3 2025 financial results, with total revenues of $7.8 billion and non-GAAP diluted EPS jumping 22% to $2.47. The performance was driven by a 4% rise in its core business (excluding Veklury), led by its HIV franchise and $3.7 billion in Biktarvy sales. Despite a decline in Veklury and Cell Therapy revenue, the company raised its full-year 2025 diluted EPS guidance.