Gilead's HIV Pipeline Gains Traction With Upcoming FDA Decision For HIV-1 Drug

In February, the U.S. Food and Drug Administration (FDA) accepted Gilead Sciences, Inc.’s GILD New Drug Application (NDA) submissions for lenacapavir — the company’s twice-yearly injectable HIV-1 capsid inhibitor — for the prevention of HIV as pre-exposure prophylaxis (PrEP).

What Happened: The FDA will review the applications under priority review and has assigned a Prescription Drug User Fee Act (PDUFA) target action date of June 19, 2025.

In June 2024, Gilead Sciences shared topline results from an interim analysis of its Phase 3 PURPOSE 1 trial, indicating its twice-yearly lenacapavir demonstrated 100% efficacy for the investigational use of HIV prevention in cisgender women.

Based on these results, the independent Data Monitoring Committee (DMC) recommended that Gilead stop the blinded phase of the trial and offer open-label lenacapavir to all participants.

Since June last year, Gilead stock has gained almost 74%, and year-to-date stock has jumped around 21%.

In March, Gilead Sciences presented data from its HIV treatment portfolio and pipeline at the Conference on Retroviruses and Opportunistic Infections (CROI 2025).

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With the breakthrough, Wall Street is paying attention again.

The company, a leader in HIV treatment, is showing signs of a successful turnaround. Despite this momentum, its stock is still relatively cheap, trading at 13.3 times forward earnings — less than the pharmaceutical industry average of 14.

Why It Matters: Some investors may worry that Gilead is repeating history. About 10 years ago, its stock surged due to the success of a cure for hepatitis C, but later, it declined as demand faded. Since then, slow growth and disappointing cancer drug deals hurt its image, making it seem like a value trap.

This time could be different — but Gilead has to deliver.

Over 400,000 Americans use PrEP. To reach $4 billion in annual sales, citing some analysts, the Wall Street Journal report expects that by 2030, Gilead must get more people on the drug and grow the market globally. The company aims to more than double U.S. PrEP users to over one million in the next 10 years.

Unlike other drugmakers facing upcoming patent expirations, Gilead is well-positioned. Its HIV drug Biktarvy, used after infection, is protected from generic competition until 2033.

It also has several next-generation HIV treatments in development, supporting its future growth.

In the first quarter of 2025, HIV product sales increased 6% year-over-year to $4.59 billion.

According to a media report in February, the Health and Human Services Department is considering substantial reductions in federal funding for domestic HIV prevention.

Mitchell Warren, executive director of HIV prevention group AVAC, says the CDC’s PrEP program could be reduced or cut. Launched last fall as a pilot program, it provides free medication to help prevent HIV.

GILD Price Action: GILD stock is up 2.19% at $111.41 at publication on Thursday.

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