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Gilead Expands Lenacapavir Access With New PAHO Deal in Latin America
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Key Takeaways
Gilead signed a PAHO deal to expand access to twice-yearly lenacapavir for HIV prevention.
The agreement adds a coordinated access pathway across 14 countries outside Gilead's licensing deals.
PAHO's Regional Revolving Funds will support coordinated procurement and country-led lenacapavir access.
Gilead Sciences (GILD - Free Report) has signed an agreement with the Pan American Health Organization (PAHO) to accelerate access to twice-yearly lenacapavir for HIV prevention across PAHO Member States in Latin America and the Caribbean. The agreement will use PAHO’s Regional Revolving Funds to create a coordinated regional procurement and access pathway, supporting country-led adoption and implementation of long-acting pre-exposure prophylaxis (PrEP). The move expands Gilead’s global access strategy across 14 countries outside its voluntary licensing agreements.
Lenacapavir is marketed as Sunlenca in the United States and the EU for treatment of multidrug-resistant HIV-1 in heavily treatment-experienced adults, in combination with other antiretrovirals. For prevention, it is sold as Yeztugo in the United States and Yeytuo in the EU for PrEP in adults and adolescents weighing at least 35 kilograms who are at increased risk of HIV-1 acquisition.
Lenacapavir stands out for its long-acting profile and distinct mechanism. It is a first-in-class HIV capsid inhibitor designed to interfere with multiple stages of the viral lifecycle, rather than acting at a single stage. Per Gilead, lenacapavir has no known in-vitro cross-resistance with existing antiretroviral classes. The twice-yearly PrEP formulation combines infrequent dosing with a distinct mechanism, potentially broadening prevention choices and addressing adherence challenges.
Under the agreement, PAHO’s Regional Revolving Funds will provide a mechanism for countries across Latin America and the Caribbean to pursue coordinated access to twice-yearly lenacapavir. The framework covers all PAHO Member States, while the immediate access pathway specifically adds 14 countries outside Gilead’s voluntary licensing arrangements: Argentina, Brazil, Chile, Colombia, Costa Rica, Ecuador, El Salvador, Guatemala, Mexico, Panama, Paraguay, Peru, Uruguay and Venezuela.
Year to date, GILD shares have gained 19.1% compared with the industry's growth of 6.8%.
Image Source: Zacks Investment Research
The arrangement complements rather than replaces Gilead’s existing generic-access strategy. The company used different approaches across markets, including voluntary licensing, technology transfer, no-profit supply and regional partnerships. By adding PAHO’s procurement and regional coordination infrastructure, Gilead can potentially reduce fragmentation in market access and help countries move from regulatory and planning stages toward implementation.
For Gilead, broader adoption could expand its HIV prevention franchise while strengthening lenacapavir access infrastructure. It has also expanded its no-profit supply commitment with PEPFAR and the Global Fund to as many as three million people through 2028. GILD’s lenacapavir is already available in 10 sub-Saharan African countries, underscoring the broader rollout underway.
The Latin American opportunity is also relevant because HIV incidence in the region increased 13% between 2010 and 2024, according to Gilead. The company is separately exploring opportunities with Brazil’s Ministry of Health to enable local production of lenacapavir, which could support longer-term regional supply objectives.
Gilead Advances Lenacapavir Across HIV Prevention and Treatment
Gilead continues to develop lenacapavir across several clinical programs. In HIV prevention, the registrational phase III PURPOSE 365 study is evaluating once-yearly lenacapavir for HIV prevention and has completed enrollment. Gilead is also developing lenacapavir across several other mid-stage studies evaluating twice-yearly dosing for HIV PrEP in different populations and geographies.
In HIV treatment, Gilead recently received FDA approval for Bixlenvo, a once-daily oral combination of bictegravir and lenacapavir, for the treatment of virologically suppressed adults with HIV. The phase III ISLEND-1 and ISLEND-2 studies are evaluating once-weekly oral islatravir/lenacapavir in virologically suppressed adults with HIV-1. Gilead is also evaluating lenacapavir in several other mid-stage studies for potential HIV treatment applications.
Gilead’s marketed HIV portfolio extends beyond lenacapavir and includes Biktarvy, Descovy and other established antiretroviral therapies. Within the lenacapavir franchise, Yeztugo generated $397 million in sales in the first half of 2026, while Sunlenca is included in GILD’s “Other HIV” category and is not reported separately. Biktarvy and Descovy remain major contributors to the company’s HIV business, generating $7.13 billion and $1.77 billion, respectively, in the first half of 2026. This established commercial base, together with Yeztugo and the broader lenacapavir pipeline, provides Gilead with multiple avenues to extend its HIV franchise.
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Precigen’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 108.96%.
Over the past 60 days, estimates for AC Immune’s 2026 loss per share have narrowed from 84 cents to 60 cents. Over the same period, earnings estimates for 2027 remained unchanged at 17 cents. ACIU shares have lost 14.7% year to date.
AC Immune’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 33.25%.
Over the past 60 days, loss per share estimates for Aldeyra Therapeutics have narrowed from 43 cents to 39 cents for 2026. Over the same period, estimates for 2027 loss per share have narrowed from 22 cents to 16 cents. ALDX shares have plunged 73.4% year to date.
Aldeyra Therapeutics’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 29.25%.
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Gilead Expands Lenacapavir Access With New PAHO Deal in Latin America
Key Takeaways
Gilead Sciences (GILD - Free Report) has signed an agreement with the Pan American Health Organization (PAHO) to accelerate access to twice-yearly lenacapavir for HIV prevention across PAHO Member States in Latin America and the Caribbean. The agreement will use PAHO’s Regional Revolving Funds to create a coordinated regional procurement and access pathway, supporting country-led adoption and implementation of long-acting pre-exposure prophylaxis (PrEP). The move expands Gilead’s global access strategy across 14 countries outside its voluntary licensing agreements.
Lenacapavir is marketed as Sunlenca in the United States and the EU for treatment of multidrug-resistant HIV-1 in heavily treatment-experienced adults, in combination with other antiretrovirals. For prevention, it is sold as Yeztugo in the United States and Yeytuo in the EU for PrEP in adults and adolescents weighing at least 35 kilograms who are at increased risk of HIV-1 acquisition.
Lenacapavir stands out for its long-acting profile and distinct mechanism. It is a first-in-class HIV capsid inhibitor designed to interfere with multiple stages of the viral lifecycle, rather than acting at a single stage. Per Gilead, lenacapavir has no known in-vitro cross-resistance with existing antiretroviral classes. The twice-yearly PrEP formulation combines infrequent dosing with a distinct mechanism, potentially broadening prevention choices and addressing adherence challenges.
PAHO Partnership Broadens GILD’s Lenacapavir Market Reach
Under the agreement, PAHO’s Regional Revolving Funds will provide a mechanism for countries across Latin America and the Caribbean to pursue coordinated access to twice-yearly lenacapavir. The framework covers all PAHO Member States, while the immediate access pathway specifically adds 14 countries outside Gilead’s voluntary licensing arrangements: Argentina, Brazil, Chile, Colombia, Costa Rica, Ecuador, El Salvador, Guatemala, Mexico, Panama, Paraguay, Peru, Uruguay and Venezuela.
Year to date, GILD shares have gained 19.1% compared with the industry's growth of 6.8%.
Image Source: Zacks Investment Research
The arrangement complements rather than replaces Gilead’s existing generic-access strategy. The company used different approaches across markets, including voluntary licensing, technology transfer, no-profit supply and regional partnerships. By adding PAHO’s procurement and regional coordination infrastructure, Gilead can potentially reduce fragmentation in market access and help countries move from regulatory and planning stages toward implementation.
For Gilead, broader adoption could expand its HIV prevention franchise while strengthening lenacapavir access infrastructure. It has also expanded its no-profit supply commitment with PEPFAR and the Global Fund to as many as three million people through 2028. GILD’s lenacapavir is already available in 10 sub-Saharan African countries, underscoring the broader rollout underway.
The Latin American opportunity is also relevant because HIV incidence in the region increased 13% between 2010 and 2024, according to Gilead. The company is separately exploring opportunities with Brazil’s Ministry of Health to enable local production of lenacapavir, which could support longer-term regional supply objectives.
Gilead Advances Lenacapavir Across HIV Prevention and Treatment
Gilead continues to develop lenacapavir across several clinical programs. In HIV prevention, the registrational phase III PURPOSE 365 study is evaluating once-yearly lenacapavir for HIV prevention and has completed enrollment. Gilead is also developing lenacapavir across several other mid-stage studies evaluating twice-yearly dosing for HIV PrEP in different populations and geographies.
In HIV treatment, Gilead recently received FDA approval for Bixlenvo, a once-daily oral combination of bictegravir and lenacapavir, for the treatment of virologically suppressed adults with HIV. The phase III ISLEND-1 and ISLEND-2 studies are evaluating once-weekly oral islatravir/lenacapavir in virologically suppressed adults with HIV-1. Gilead is also evaluating lenacapavir in several other mid-stage studies for potential HIV treatment applications.
Gilead’s marketed HIV portfolio extends beyond lenacapavir and includes Biktarvy, Descovy and other established antiretroviral therapies. Within the lenacapavir franchise, Yeztugo generated $397 million in sales in the first half of 2026, while Sunlenca is included in GILD’s “Other HIV” category and is not reported separately. Biktarvy and Descovy remain major contributors to the company’s HIV business, generating $7.13 billion and $1.77 billion, respectively, in the first half of 2026. This established commercial base, together with Yeztugo and the broader lenacapavir pipeline, provides Gilead with multiple avenues to extend its HIV franchise.
Gilead Sciences, Inc. Price and Consensus
Gilead Sciences, Inc. price-consensus-chart | Gilead Sciences, Inc. Quote
GILD’s Zacks Rank and Stocks to Consider
Gilead currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Precigen (PGEN - Free Report) , currently sporting a Zacks Rank #1 (Strong Buy), and AC Immune (ACIU - Free Report) and Aldeyra Therapeutics (ALDX - Free Report) , carrying a Zacks Rank #2 (Buy) each. You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Precigen’s 2026 bottom line have improved from a loss of 2 cents to earnings per share of 25 cents. Over the same period, earnings estimates for 2027 have risen from 25 cents to 86 cents. PGEN shares have increased 67.5% year to date.
Precigen’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 108.96%.
Over the past 60 days, estimates for AC Immune’s 2026 loss per share have narrowed from 84 cents to 60 cents. Over the same period, earnings estimates for 2027 remained unchanged at 17 cents. ACIU shares have lost 14.7% year to date.
AC Immune’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 33.25%.
Over the past 60 days, loss per share estimates for Aldeyra Therapeutics have narrowed from 43 cents to 39 cents for 2026. Over the same period, estimates for 2027 loss per share have narrowed from 22 cents to 16 cents. ALDX shares have plunged 73.4% year to date.
Aldeyra Therapeutics’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 29.25%.