Gilead prepares for mid-2025 launch of Lenacapavir for HIV prevention

USA – Gilead Sciences is gearing up to launch lenacapavir, a long-acting pre-exposure prophylaxis (PrEP) drug for HIV prevention, by mid-2025.

The company is awaiting FDA approval, which is expected in June, and has already begun making preparations for its rollout in the U.S.

The announcement was made during Gilead’s fourth-quarter and full-year earnings call, where Chief Commercial Officer Johanna Mercier confirmed that plans for lenacapavir’s availability this summer are well underway.

Demand is expected to be strong, with Gilead already seeing a rise in HIV-related doctor appointments in anticipation of the drug’s approval, according to analysts at Jefferies.

Lenacapavir’s strong clinical data and FDA fast-track review

Gilead submitted its lenacapavir application to the FDA in December 2024, supported by data from its Phase III PURPOSE clinical program.

The drug was granted Breakthrough Therapy designation in October 2024, a status that helps accelerate the review process. However, Gilead has not yet announced a target approval date.

Clinical trials have shown lenacapavir’s impressive effectiveness. In the PURPOSE 1 study, which included 2,134 women, a twice-yearly injection of lenacapavir prevented 100% of HIV infections, outperforming Gilead’s existing oral PrEP drugs Truvada and Descovy.

Meanwhile, PURPOSE 2 data, released in September 2024, demonstrated a 96% reduction in HIV risk among cisgender men, transgender men, transgender women, and gender non-binary individuals who have sex with partners assigned male at birth.

Gilead’s confidence in Lenacapavir’s impact

Despite the expected strong demand, Gilead anticipates a gradual rollout. Mercier noted that around 75% of patients should have access to the drug within six months of launch, increasing to 90% within a year.

She emphasized that lenacapavir will make a significant impact in 2025, with an even greater effect in 2026 and beyond.

Gilead’s strong Q4 performance and future outlook

Gilead ended 2024 on a high note, reporting a 6% increase in fourth-quarter revenue to US $7.6 billion, exceeding the US $7.1 billion consensus estimate.

For the full year, the company’s revenue grew to US $28.8 billion, driven by strong sales of HIV drug Biktarvy (US $3.77 billion) and CAR T therapies Trodelvy (US $365 million) and Yescarta (US $390 million).

Analysts at BMO Capital Markets called Gilead’s Q4 results “a solid end to 2024”, reinforcing the company’s dominance in the HIV treatment space.

With lenacapavir’s launch on the horizon, Gilead is projecting product sales between US $28.2 billion and US $28.6 billion for 2025.

If approved, lenacapavir could transform HIV prevention by offering a long-lasting alternative to daily PrEP pills, making protection against HIV easier and more accessible for at-risk populations.