News Related to Islatravir

Gilead's Lenacapavir Advances: FDA Accepts Weekly Oral PrEP Application, Global Access Expands

Jun 16, 2026

The U.S. FDA has accepted Gilead's application for an investigational once-weekly oral lenacapavir for HIV prevention, with a review date set for February 2027. Concurrently, PEPFAR and The Global Fund are expanding access to the twice-yearly injectable version to a total of 3 million people by 2028. Gilead will present new data on both lenacapavir and a novel bictegravir/lenacapavir combination at CROI 2026.

FDA Drug Approval Decisions Expected in April 2026

Mar 18, 2026

The FDA is set to make decisions on four drug applications in April 2026, including Orca-T for hematological malignancies, orforglipron for obesity, sparsentan for kidney disease, and a doravirine/islatravir combination for HIV-1.

Merck's Two-Drug HIV Regimen Meets Primary Endpoint in Phase 3 Trial

Feb 27, 2026

Merck announced Phase 3 trial results for its investigational once-daily, two-drug HIV regimen doravirine/islatravir at CROI 2026, demonstrating non-inferiority to standard treatment in treatment-naïve adults with viral suppression rates of 91.8% at Week 48.

Merck Stock Surges 46% to 52-Week High on Post-Keytruda Pipeline Strength

Feb 13, 2026

Merck stock reached a 52-week high at $122.69, rising 46.25% over 12 months and 7.4% in the past month following strong Q4 results and improved long-term pipeline outlook beyond Keytruda's 2028 patent expiration.