Gilead’s twice-yearly PrEP injection wins FDA approval, analysts see solid launch ahead

Gilead Sciences Inc (NASDAQ:GILD, ETR:GIS)’s twice-yearly injectable HIV prevention drug lenacapavir is on track for a solid launch after being officially approved by the US Food and Drug Administration (FDA) on Wednesday, analysts at Jefferies believe.

Lenacapavir, marketed as Yeztugo, is the first pre-exposure prophylaxis (PrEP) drug requiring only two treatments per year, offering a significant convenience advantage over daily oral PrEP and cabotegravir, which requires six injections per year.

“Today's new lenacapavir PrEP approval is a nice de-risking event and good to see an on-time approval with FDA reviewers not missing a beat on this important biotech approval, noting the quick six-month Priority Review and Breakthrough Therapy Designation,” the analysts wrote.

“While not a controversial approval, we now look to execution, and the focus is now on the launch and if they can execute, especially on reimbursement.”

Gilead is expected to price Yeztugo close to Descovy, another oral PrEP option, with a gross annual cost of around $26,000. Net pricing could land closer to $20,000 due to less aggressive rebating, the analysts noted.

This pricing strategy, combined with strong initial access expectations, sets up Gilead for a solid launch trajectory in the second half of 2025, they believe.

Wall Street projects 2025 PrEP revenue for Yeztugo in the $135 million to $150 million range, and Jefferies analysts believe that’s attainable if roughly 15,000 patients transition from existing PrEP options like Descovy, Truvada, or Apretude. This would represent just 0.5% to 1% of the current PrEP market.

Gilead has indicated that it expects 75% unrestricted payer access by year-end 2025, rising to 90% by mid-2026. If that timeline holds, Yeztugo uptake should accelerate in Q4 and into 2026, the analysts noted.

Yeztugo could generate up to $750 million in sales in 2026, according to consensus estimates, implying approximately 47,000 patients will have transitioned to the new therapy by then. That would represent a modest 1% to 2% share shift from existing therapies, which Jefferies sees as manageable, provided Gilead executes well on commercial access and reimbursement strategies.

Jefferies sees Gilead stock moving higher if it can execute a “good launch,” at least in line or better than Street expectations.

The analysts repeated their ‘Buy’ rating on Gilead and $130 price target, implying upside of 20% at the time of writing. “Biotech stocks with good launches are a particularly good place to be this year given volatility,” they concluded.