Doravirine/islatravir would be the first FDA-approved two-drug regimen without an integrase inhibitor that demonstrated non-inferior efficacy and a generally comparable safety profile to the three-drug InSTI-based regimen, BIC/FTC/TAF, in a Phase 3 pivotal trial Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for doravirine/islatravir (DOR/ISL), an investigational, once-daily, oral, two-drug regimen for adults with HIV-1 infection that is virologically suppressed on antiretroviral therapy. The FDA has set a target action date of April 28, 2026, for the application under the Prescription Drug User Fee Act (PDUFA). “Merck has been at the forefront of HIV research for more than 35 years and we are pleased to continue our work to innovate and deliver new options that aim to meet the needs of the HIV community,” said Dr. Eliav Barr, senior vice

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that new data from its research pipeline for HIV prevention and treatment will be presented at the 13th International AIDS Society Conference on HIV Science (IAS 2025) taking place July 13-17, 2025, in Kigali, Rwanda. Merck will share new scientific findings from its HIV clinical development programs, including Phase 2 data on the safety and pharmacokinetics of MK-8527, an investigational, novel nucleoside reverse transcriptase translocation inhibitor (NRTTI), dosed orally once monthly, in development for the prevention of HIV as pre-exposure prophylaxis (PrEP). HIV clinical data presented at IAS 2025 from three Phase 3 trials (P051: NCT05631093; P052: NCT05630755; P054: NCT05766501) will examine the impact of preexisting resistance-associated mutations (RAMs) in proviral DNA on the virologic response to doravirine/islatravir (DOR/ISL), with a primary focus on M184I/V in proviral DNA. Data will