FDA Approves Gilead's Twice-Yearly Shot for HIV Prevention

Globe and Mail

6 hours ago

Gilead Sciences, Inc. GILD obtained FDA approval for its twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir, for the prevention of HIV.
The regulatory body approved lenacapavir, under the brand name Yeztugo, for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 35kg.
This groundbreaking injectable therapy marks the first and only twice-yearly PrEP option available in the United States.
The FDA nod, granted under Priority Review, was based on extraordinary data from the late-stage studies, PURPOSE 1 and PURPOSE 2, which showed that ≥99.9% of participants who received Yeztugo remained HIV-negative.
Year to date, shares of GILD have gained 18.6% against the industry 's decline of 4%.
More on GILD's Yeztugo
The approval of Yeztugo for HIV prevention is a major breakthrough in the fight against HIV epidemic.
At present, there are two FDA-approved daily oral medications for PrEP — Truvada and Descovy. Both of these are marketed by GILD alone.
Please note that Descovy for PrEP is indicated in at-risk adults and adolescents (≥35 kg) to reduce the risk of sexually acquired HIV-1 infection, excluding individuals at risk from receptive vaginal sex.
Truvada is a two-drug combination of emtricitabine and tenofovir disoproxil fumarate, approved for the treatment of HIV-1 infection and PrEP.
Data from PURPOSE 1 study showed that twice-yearly subcutaneous Yeztugo demonstrated zero HIV infections among 2,134 participants in the Yeztugo group, 100% reduction in HIV infections and superiority of prevention of HIV infections when compared with once-daily oral Truvada in cisgender women in sub-Saharan Africa.
Data from the PURPOSE 2 study showed that 99.9% of participants in the Yeztugo group did not acquire HIV infection. Yeztugo was also superiority in preventing of HIV infections when compared with once-daily oral Truvada among a broad and geographically diverse range of cisgender men and gender-diverse people.
Yeztugo also demonstrated superiority of prevention of HIV infections when compared with background HIV incidence (bHIV) and was generally well-tolerated, with no significant or new safety concerns identified.
Yeztugo was also granted Breakthrough Therapy Designation in October 2024.
The European Medicines Agency has also validated the Marketing Authorization Application for twice-yearly lenacapavir for HIV prevention.
Yeztugo Approval – A Significant Boost for GILD
As the first long-acting injectable PrEP administered just twice a year, Yeztugo addresses persistent barriers that have limited broader PrEP adoption, such as challenges with daily oral PrEP, adherence, stigma and healthcare access.
This approval represents a paradigm shift in HIV prevention and is expected to catalyze uptake among populations that have historically been underserved by existing prevention tools. Yeztugo has a competitive advantage as it needs to be taken only twice yearly, unlike daily oral pills, and addresses a broad population.
Gilead has a market-leading portfolio of HIV treatments. Flagship drug Biktarvy accounts for over 51% share of the treatment market in the United States and should maintain momentum.
The approval of Yeztugon solidifies its HIV portfolio as its other prevention drug, Truvada, faces generic competition.
We note that lenacapavir is already approved in multiple countries for the treatment of adults with multi-drug resistant HIV in combination with other antiretrovirals. It is also approved in the United States to reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 35kg, who are at risk of HIV acquisition.
A long-acting injectable form of PrEP was also approved by the FDA. In 2021, the regulatory body approved ViiV Healthcare's Apretude (cabotegravir extended-release injectable suspension) for use in at-risk adults and adolescents weighing at least 35 kg for PrEP to reduce the risk of sexually acquired HIV.
ViiV Healthcare is a global specialist HIV company, majorly owned by GSK plc GSK, with Pfizer and Shionogi as shareholders. The company was formed by GSK and Pfizer in 2009.
Apretude is given first as two initiation injections, administered a month apart and then every two months. Patients in need can either start their treatment with Apretude or take oral cabotegravir (Vocabria) for four weeks to understand how well they can tolerate the drug.
Approval of better HIV treatments should strengthen GILD's HIV franchise in the wake of increasing competition from the likes of GSK.
GSK's HIV portfolio sales are being driven by strong patient demand for Cabenuva, Apretude and Dovato. The company is also focused on the development of the next generation of HIV innovation with integrase inhibitors (INSTIs) for HIV treatment and prevention.
GILD's Zacks Rank and Stocks to Consider
Gilead currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the pharma/biotech sector are Novartis NVS and Bayer BAYRY, both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.
The Zacks Consensus Estimate for Novartis' 2025 earnings per share (EPS) has risen from $8.53 to $8.74 over the past 60 days. EPS estimates for 2026 have jumped 23 cents to $9.02 during this timeframe. The stock has risen 22% so far this year.
BAYRY's 2025 EPS estimate has increased from $1.19 to $1.25 for 2025 over the past 60 days, while that for 2026 has gone up from $1.28 to $1.31 over the same timeframe. Year to date, shares of Bayer have surged 59.8%.
BAYRY's earnings beat estimates in one of the trailing four quarters, matched twice and missed on the remaining occasion, the average negative surprise being 13.91%.
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