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GILD's Bictegravir and Lenacapavir Regimen for HIV Meets Primary Goal
Read MoreHide Full Article
Key Takeaways
GILD's ARTISTRY-2 showed once-daily BIC/LEN was non-inferior to Biktarvy at week 48.
GILD randomized virologically suppressed patients 2:1 to switch to BIC/LEN or stay on Biktarvy.
GILD plans regulatory filings combining phase III results from ARTISTRY-1 and ARTISTRY-2.
Gilead Sciences, Inc. (GILD - Free Report) announced that the investigational single-tablet regimen of bictegravir and lenacapavir for the treatment of HIV met the primary endpoint in the late-stage ARTISTRY-2 study.
ARTISTRY-2 is a multicenter, double-blind, randomized phase III study comparing the safety and efficacy of an investigational once-daily combination of bictegravir and lenacapavir (BIC/LEN) versus Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) in people with HIV who are virologically suppressed.
Participants receiving Biktarvy were randomized in a 2:1 ratio to either switch to bictegravir 75 mg/lenacapavir 50 mg or continue on their existing regimen.
The primary endpoint was the proportion of patients with HIV-1 RNA ≥50 copies/mL at week 48 as determined by the FDA-defined snapshot algorithm.
Data showed BIC/LEN efficacy was found to be statistically non-inferior to Biktarvy.
More on GILD’s ARTISTRY Studies
We note that bictegravir is a global guideline-recommended integrase strand transfer inhibitor (INSTI) with a high barrier to resistance. INSTIs are a class of antiretroviral agents that target the viral integrase.
On the other hand, lenacapavir was recently approved as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in adults and adolescents who are at risk of HIV acquisition. It is also approved in multiple countries for the treatment of multi-drug-resistant HIV in adults, in combination with other antiretrovirals.
According to Gilead, a single-tablet regimen combining bictegravir and lenacapavir could further reshape the HIV treatment landscape by broadening options that help people with HIV maintain virologic suppression while benefiting from one of the latest advances in HIV drug development.
In ARTISTRY-2, the once-daily single tablet regimen of BIC/LEN met the primary success criterion for non-inferiority to Biktarvy.
Last month, Gilead announced that its investigational single-tablet regimen of bictegravir and lenacapavir for HIV-1 treatment met the primary endpoint in the late-stage ARTISTRY-1 study.
Gilead plans to file the phase III results from the ARTISTRY studies with regulatory authorities. The results of ARTISTRY-2 will be combined with the findings from the ARTISTRY-1 study to form the basis of regulatory submissions.
GILD’s Strong HIV Franchise Maintains Momentum
Gilead has a market-leading HIV franchise, led by flagship HIV therapies — Biktarvy and Descovy. Biktarvy sales and Descovy for pre-exposure prophylaxis (PrEP) have fueled GILD’s top-line growth over the past several quarters.
Flagship HIV therapy Biktarvy is the top revenue generator for GILD. Per GILD, Biktarvy accounts for more than 52% share of the treatment market in the United States, and continues to be the leader in major markets around the world.
Roughly 75% of Descovy sales are for HIV prevention. Descovy currently accounts for more than 45% of the U.S. market share in the PrEP market.
GILD’s HIV portfolio received a boost with the FDA approval for its twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir, for the prevention of HIV. This groundbreaking injectable therapy marks the first and only twice-yearly PrEP option available in the United States.
Gilead’s shares have gained 29.7% year to date compared with the industry's growth of 18.9%.
Image Source: Zacks Investment Research
The FDA approval of lenacapavir under the brand name Yeztugo solidifies GILD’s HIV portfolio as its other prevention drug, Truvada, faces generic competition.
The initial uptake of Yeztugo looks good. Yeztugo has a competitive advantage as it needs to be taken only twice a year, unlike daily oral pills, and addresses a broad population. Yeztugo for PrEP raked in sales of $39 million in the third quarter. GILD stated that it achieved its 75% coverage goal for Yeztugo, nearly three months ahead of its target. Gilead continues to target achieving 90% coverage by the end of the first half next year.
Positive data from the phase III ARTISTRY-1 and ARTISTRY-2 studies is a significant boost for the company.
Approval of better HIV treatments should strengthen the HIV franchise in the wake of increasing competition from the likes of GSK plc (GSK - Free Report) .
GSK continues to grow its HIV business, driven by strong patient demand for long-acting injectable medicines (Cabenuva and Apretude) and Dovato.
In the past 60 days, estimates for CorMedix’s 2025 earnings per share (EPS) have increased from $1.85 to $2.87. EPS estimates for 2026 have moved up from $2.49 to $2.88 during the same period. CRMD stock has risen 39.8% year to date. CorMedix’s earnings beat estimates in each of the trailing four quarters, with an average surprise of 27.04%.
In the past 60 days, estimates for Amicus Therapeutics’ 2025 EPS have increased to 36 cents from 31 cents. During the same time, EPS estimates for 2026 have decreased to 67 cents from 70 cents. Year to date, shares of FOLD have gained 15.5%.
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GILD's Bictegravir and Lenacapavir Regimen for HIV Meets Primary Goal
Key Takeaways
Gilead Sciences, Inc. (GILD - Free Report) announced that the investigational single-tablet regimen of bictegravir and lenacapavir for the treatment of HIV met the primary endpoint in the late-stage ARTISTRY-2 study.
ARTISTRY-2 is a multicenter, double-blind, randomized phase III study comparing the safety and efficacy of an investigational once-daily combination of bictegravir and lenacapavir (BIC/LEN) versus Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) in people with HIV who are virologically suppressed.
Participants receiving Biktarvy were randomized in a 2:1 ratio to either switch to bictegravir 75 mg/lenacapavir 50 mg or continue on their existing regimen.
The primary endpoint was the proportion of patients with HIV-1 RNA ≥50 copies/mL at week 48 as determined by the FDA-defined snapshot algorithm.
Data showed BIC/LEN efficacy was found to be statistically non-inferior to Biktarvy.
More on GILD’s ARTISTRY Studies
We note that bictegravir is a global guideline-recommended integrase strand transfer inhibitor (INSTI) with a high barrier to resistance. INSTIs are a class of antiretroviral agents that target the viral integrase.
On the other hand, lenacapavir was recently approved as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in adults and adolescents who are at risk of HIV acquisition. It is also approved in multiple countries for the treatment of multi-drug-resistant HIV in adults, in combination with other antiretrovirals.
According to Gilead, a single-tablet regimen combining bictegravir and lenacapavir could further reshape the HIV treatment landscape by broadening options that help people with HIV maintain virologic suppression while benefiting from one of the latest advances in HIV drug development.
In ARTISTRY-2, the once-daily single tablet regimen of BIC/LEN met the primary success criterion for non-inferiority to Biktarvy.
Last month, Gilead announced that its investigational single-tablet regimen of bictegravir and lenacapavir for HIV-1 treatment met the primary endpoint in the late-stage ARTISTRY-1 study.
Gilead plans to file the phase III results from the ARTISTRY studies with regulatory authorities. The results of ARTISTRY-2 will be combined with the findings from the ARTISTRY-1 study to form the basis of regulatory submissions.
GILD’s Strong HIV Franchise Maintains Momentum
Gilead has a market-leading HIV franchise, led by flagship HIV therapies — Biktarvy and Descovy. Biktarvy sales and Descovy for pre-exposure prophylaxis (PrEP) have fueled GILD’s top-line growth over the past several quarters.
Flagship HIV therapy Biktarvy is the top revenue generator for GILD. Per GILD, Biktarvy accounts for more than 52% share of the treatment market in the United States, and continues to be the leader in major markets around the world.
Roughly 75% of Descovy sales are for HIV prevention. Descovy currently accounts for more than 45% of the U.S. market share in the PrEP market.
GILD’s HIV portfolio received a boost with the FDA approval for its twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir, for the prevention of HIV. This groundbreaking injectable therapy marks the first and only twice-yearly PrEP option available in the United States.
Gilead’s shares have gained 29.7% year to date compared with the industry's growth of 18.9%.
Image Source: Zacks Investment Research
The FDA approval of lenacapavir under the brand name Yeztugo solidifies GILD’s HIV portfolio as its other prevention drug, Truvada, faces generic competition.
The initial uptake of Yeztugo looks good. Yeztugo has a competitive advantage as it needs to be taken only twice a year, unlike daily oral pills, and addresses a broad population. Yeztugo for PrEP raked in sales of $39 million in the third quarter. GILD stated that it achieved its 75% coverage goal for Yeztugo, nearly three months ahead of its target. Gilead continues to target achieving 90% coverage by the end of the first half next year.
Positive data from the phase III ARTISTRY-1 and ARTISTRY-2 studies is a significant boost for the company.
Approval of better HIV treatments should strengthen the HIV franchise in the wake of increasing competition from the likes of GSK plc (GSK - Free Report) .
GSK continues to grow its HIV business, driven by strong patient demand for long-acting injectable medicines (Cabenuva and Apretude) and Dovato.
GILD’s Zacks Rank and Stocks to Consider
GILD currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the biotech sector are CorMedix (CRMD - Free Report) and Amicus Therapeutics (FOLD - Free Report) , both sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for CorMedix’s 2025 earnings per share (EPS) have increased from $1.85 to $2.87. EPS estimates for 2026 have moved up from $2.49 to $2.88 during the same period. CRMD stock has risen 39.8% year to date. CorMedix’s earnings beat estimates in each of the trailing four quarters, with an average surprise of 27.04%.
In the past 60 days, estimates for Amicus Therapeutics’ 2025 EPS have increased to 36 cents from 31 cents. During the same time, EPS estimates for 2026 have decreased to 67 cents from 70 cents. Year to date, shares of FOLD have gained 15.5%.