Gilead Sciences Inc. (NASDAQ:GILD) is one of the most undervalued quality stocks to buy according to hedge funds. On July 25, the European Medicines Agency’s Committee for Medicinal Products for Human Use/CHM recommended the approval of Gilead Sciences’ lenacapavir, which is a twice-yearly injection for preventing HIV infection. The recommendation, if followed by the European Commission/EC, would make lenacapavir the first HIV prevention medicine in the EU not administered on a daily, weekly, or monthly basis. In Europe, the drug is marketed under the brand name Yeytuo. It is intended to be used as a pre-exposure prophylaxis/PrEP in conjunction with safer sex practices to lower the risk of HIV-1 infection in adults and adolescents at high risk. The CHMP’s positive opinion was based on data from two Phase III trials, PURPOSE 1 and PURPOSE 2. The medication works by inhibiting HIV-1 viral replication. A similar twice-yearly injectable version of lenacapavir, known as Yeztugo, was approved in the US by the FDA in June this year. According to the WHO, an estimated 1.3 million people were newly infected with HIV in 2024. Gilead Sciences Inc. (NASDAQ:GILD) is a biopharmaceutical company that discovers, develops, and commercializes medicines in the areas of unmet medical need in the US, Europe, and internationally.

Gilead Sciences’ Twice-Yearly HIV Prevention Drug Recommended for Approval by European Medicines Agency

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Gilead Sciences' lenacapavir, a twice-yearly injectable HIV prevention drug, for use in the EU. If approved, it would become the first HIV prevention medicine in Europe not administered daily, weekly, or monthly. The drug, marketed as Yeytuo, is intended as pre-exposure prophylaxis (PrEP) for adults and adolescents at high risk of HIV-1 infection. The recommendation is based on data from two Phase III trials, PURPOSE 1 and PURPOSE 2. A similar version, Yeztugo, was previously approved by the U.S. FDA in June 2025. The WHO estimates that 1.3 million new HIV infections occurred globally in 2024.