Gilead Sciences won European approval Tuesday for its new twice-annual HIV prevention shot, now called Yeytuo.
The approval comes two months after the Food and Drug Administration signed off on Yeztugo, the drug's branded name in the U.S. The twice-a-year shot has proved 99.9% effective in preventing the virus from taking hold in people at risk of contracting HIV.
Gilead said Yeytuo is the first and only twice annual pre-exposure prophylaxis, or PrEP, treatment available in the European Union's 27 member states, as well as Norway, Iceland and Liechtenstein. The approval is accelerated with the Committee for Medicinal products for Human Use describing Yeytuo as being a product of "major interest for public health."
"Yeytuo's rapid authorization by the European Commission underscores the rigor of our clinical data and the transformative potential of Yeytuo to help address the urgent unmet need in HIV prevention across Europe," Gilead Chief Medical Officer Dietmar Berger said in a written statement.
Gilead stock, though, has pulled back somewhat over the last few weeks. After breaking out of a consolidation with a buy point at 119.96 on Aug. 8, shares are now about 5% below their entry. Savvy investors are encouraged to cut their losses when a stock falls 7% to 8% below its buy point.
At Tuesday's close, Gilead stock rose a fraction to 114.75.
Gilead Stock Faces A Setback
In addition to the FDA approval, the World Health Organization recommended the twice-yearly shot as an additional PrEP option for HIV prevention, Gilead said in a news release.
But Gilead faced a setback last week after CVS Health said it wouldn't add Yeztugo to its commercial plans for now. It also won't cover the drug under its Affordable Care Act subsidiaries.
A spokesman for CVS noted there are other HIV PrEP drugs on the market. Those are recommended by the U.S. Preventive Services Task Force. The USPSTF makes recommendations to the Department of Health and Human Services. It hasn't added Yeztugo to its list of recommended HIV PrEP drugs.
He also referenced the price tag for Yeztugo, which goes for $28,000 before insurance, rebates and discounts kick in.
Still, Gilead stock has climbed nearly 35% this year, as of Monday's close. Shares have an IBD Digital Composite Rating of 90, putting their fundamental and technical performance in the leading 10% of all stocks.
Follow Allison Gatlin on X/Twitter at @AGatlin_IBD.
