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GILD Wins Approval for Twice-Yearly HIV Prevention Shot in the EU
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Key Takeaways
The EC approved Gileads lenacapavir, branded Yeytuo, as twice-yearly HIV prevention for at-risk groups.
Approval followed accelerated EMA review, CHMP backing, and PURPOSE 1 and 2 trial data.
Lenacapavir strengthens Gileads HIV portfolio as Truvada faces generic competition in prevention.
Gilead Sciences, Inc. ((GILD - Free Report) ) announced that the European Commission (“EC”) has granted marketing authorization to HIV prevention drug lenacapavir, under the brand name Yeytuo.
The EC approved lenacapavir, GILD’s twice-yearly injectable HIV-1 capsid inhibitor, for use as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents with increased HIV-1 acquisition risk who weigh at least 35kg.
Lenacapavir was also approved by the FDA for the aforementioned indication as Yeztugo in June 2025.
Gilead’s shares have surged 23.5% year to date compared with the industry's growth of 2.2%.
Image Source: Zacks Investment Research
More on GILD’s Lenacapavir Approval in the EU
GILD’s marketing authorization application (MAA) for lenacapavir was reviewed under an accelerated timeline, following the European Medicines Agency’s (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”) assessment that twice-yearly Yeytuo is a product of major public health interest.
In July, the CHMP gave a positive opinion recommending Yeytuo for EC authorization.
In addition, lenacapavir has also been granted an additional year of market protection in the EU as a result of the new indication. This grant follows a scientific evaluation prior to authorization, which found that it brought significant clinical benefit compared to existing therapies.
The approval in the EU was supported by data from the late-stage PURPOSE 1 and PURPOSE 2 trials.
Data from the phase III PURPOSE 1 study showed that administration of twice-yearly subcutaneous lenacapavir led to zero HIV infections among 2,134 participants, 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 phase III PURPOSE 2 study showed there were two HIV infections among 2,179 participants in the twice-yearly subcutaneous lenacapavir group, demonstrating 99.9% of participants did not acquire HIV infection and superiority of prevention of HIV infections when compared with once-daily oral Truvada among a broad and geographically diverse range of cisgender men and gender-diverse people.
Lenacapavir Approval Solidifies GILD’s HIV Portfolio
The approval of lenacapavir solidifies GILD’s HIV portfolio as its other prevention drug, Truvada, faces generic competition.
At present, there are two FDA-approved daily oral medications for PrEP— Truvada and Descovy. Both are marketed by GILD.
As the first long-acting injectable PrEP administered just twice a year, Yeztugo addresses persistent barriers, such as challenges with daily oral PrEP, adherence, stigma and healthcare access, which have limited broader PrEP adoption.
Yeztugo has a competitive advantage as it needs to be taken only twice a year, 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.
Descovy for PrEP is also witnessing good uptake. It maintains over 40% market share in the PrEP market in the United States.
We note that lenacapavir is already approved in multiple countries for the treatment of adults with multidrug-resistant HIV in combination with other antiretrovirals.
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 - Free Report) ), with Pfizer ((PFE - Free Report) ) 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.
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.
However, shares of GILD slipped last week after pharmacy benefit manager CVS Health ((CVS - Free Report) ) decided not to add Yeztugo to its commercial plans for now.
As per a news report by Reuters, this decision by CVS Health was based on clinical, financial and regulatory factors. The pharmacy benefit manager will not cover Yeztugo under its Affordable Care Act formularies, since its ACA preventive program follows recommendations and mandates from the U.S. Department of Health and Human Services.
Per reports, GILD is still negotiating with CVS over Yeztugo , which currently carries a U.S. list price of more than $28,000 a year.
Image: Bigstock
GILD Wins Approval for Twice-Yearly HIV Prevention Shot in the EU
Key Takeaways
Gilead Sciences, Inc. ((GILD - Free Report) ) announced that the European Commission (“EC”) has granted marketing authorization to HIV prevention drug lenacapavir, under the brand name Yeytuo.
The EC approved lenacapavir, GILD’s twice-yearly injectable HIV-1 capsid inhibitor, for use as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents with increased HIV-1 acquisition risk who weigh at least 35kg.
Lenacapavir was also approved by the FDA for the aforementioned indication as Yeztugo in June 2025.
Gilead’s shares have surged 23.5% year to date compared with the industry's growth of 2.2%.
Image Source: Zacks Investment Research
More on GILD’s Lenacapavir Approval in the EU
GILD’s marketing authorization application (MAA) for lenacapavir was reviewed under an accelerated timeline, following the European Medicines Agency’s (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”) assessment that twice-yearly Yeytuo is a product of major public health interest.
In July, the CHMP gave a positive opinion recommending Yeytuo for EC authorization.
In addition, lenacapavir has also been granted an additional year of market protection in the EU as a result of the new indication. This grant follows a scientific evaluation prior to authorization, which found that it brought significant clinical benefit compared to existing therapies.
The approval in the EU was supported by data from the late-stage PURPOSE 1 and PURPOSE 2 trials.
Data from the phase III PURPOSE 1 study showed that administration of twice-yearly subcutaneous lenacapavir led to zero HIV infections among 2,134 participants, 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 phase III PURPOSE 2 study showed there were two HIV infections among 2,179 participants in the twice-yearly subcutaneous lenacapavir group, demonstrating 99.9% of participants did not acquire HIV infection and superiority of prevention of HIV infections when compared with once-daily oral Truvada among a broad and geographically diverse range of cisgender men and gender-diverse people.
Lenacapavir Approval Solidifies GILD’s HIV Portfolio
The approval of lenacapavir solidifies GILD’s HIV portfolio as its other prevention drug, Truvada, faces generic competition.
At present, there are two FDA-approved daily oral medications for PrEP — Truvada and Descovy. Both are marketed by GILD.
As the first long-acting injectable PrEP administered just twice a year, Yeztugo addresses persistent barriers, such as challenges with daily oral PrEP, adherence, stigma and healthcare access, which have limited broader PrEP adoption.
Yeztugo has a competitive advantage as it needs to be taken only twice a year, 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.
Descovy for PrEP is also witnessing good uptake. It maintains over 40% market share in the PrEP market in the United States.
We note that lenacapavir is already approved in multiple countries for the treatment of adults with multidrug-resistant HIV in combination with other antiretrovirals.
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 - Free Report) ), with Pfizer ((PFE - Free Report) ) 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.
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.
However, shares of GILD slipped last week after pharmacy benefit manager CVS Health ((CVS - Free Report) ) decided not to add Yeztugo to its commercial plans for now.
As per a news report by Reuters, this decision by CVS Health was based on clinical, financial and regulatory factors. The pharmacy benefit manager will not cover Yeztugo under its Affordable Care Act formularies, since its ACA preventive program follows recommendations and mandates from the U.S. Department of Health and Human Services.
Per reports, GILD is still negotiating with CVS over Yeztugo , which currently carries a U.S. list price of more than $28,000 a year.
GILD’s Zacks Rank
Gilead presently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.