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StocksMedium•25 February 2026•

1 min read

Merck’s HIV Drug Matches Gilead’s Biktarvy in Phase 3 Trials, Awaits FDA Approval

Key Facts

1Merck's two-drug HIV regimen matched Gilead's blockbuster Biktarvy in Phase 3 trials.

2The new treatment is currently under FDA review.

Merck has announced successful Phase 3 clinical trial results for its new two-drug HIV treatment regimen, which demonstrated non-inferiority to Gilead Sciences' blockbuster drug, Biktarvy. The new treatment is currently under review by the U.S. Food and Drug Administration (FDA), signaling a potential near-term market entry. This development is a critical component of Merck’s strategy to diversify its portfolio ahead of the upcoming patent cliff for its top-selling cancer drug, Keytruda. By securing a foothold in the competitive HIV market, Merck aims to establish sustainable revenue streams to offset future losses. The positive trial data poses a significant competitive challenge to Gilead’s long-standing dominance in the HIV therapeutic space. Analysts view this progress as a strategic hedge that strengthens Merck's long-term growth prospects.