FDA Places Clinical Hold on Gilead's HIV Studies, Stock Down

Gilead Sciences, Inc. GILD announced that the FDA has placed a clinical hold on studies on pipeline candidates, GS-1720 and/or GS-4182, for the treatment of HIV.

GS-1720 is an investigational integrase strand transfer inhibitor and/or GS-4182 is an investigational capsid inhibitor.

Shares were down 2.6% on the news.

Year to date, shares of GILD have gained 20% against the industry’s decline of 0.5%.    

More on GILD’s HIV Treatments

The FDA placed a clinical hold on the studies due to the identification of a safety signal of decreases in CD4+T-cell (CD4) and absolute lymphocyte counts in a subset of participants receiving the combination of GS-1720 and GS-4182.

The studies that have been placed on hold are a phase II/III study evaluating the safety and efficacy of oral weekly regimen of GS-1720 in combination with GS-4182 versus Biktarvy in virologically suppressed people with HIV-1 and a phase II/III study evaluating the safety and efficacy of oral weekly regimen of GS-1720 in combination with GS-4182 versus Biktarvy in treatment-naive people with HIV-1.

Three additional phase I studies of either these candidates/or their combinations are also on hold.

While the clinical hold will somewhat derail the development program for these candidates, GILD is a market leader in HIV treatments.

GILD’s Leading HIV Franchise Will Continue Momentum

Gilead’s flagship drug, Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg, BIC/FTC/TAF), for HIV-1 infection has become the leading prescribed regimen for both treatment-naïve and switch patients. Biktarvy accounts for over 51% share of the treatment market in the United States and should maintain momentum for GILD in the upcoming quarters.  

Descovy (FTC 200 mg/TAF 25 mg) for pre-exposure prophylaxis (PrEP) is also witnessing good uptake. It maintains over 40% market share in the PrEP market in the United States.

Gilead’s efforts to innovate its HIV portfolio are impressive. Late-stage studies, PURPOSE 1 and PURPOSE 2, validated lenacapavir’s potential to prevent HIV. The FDA accepted new drug application submissions for twice-yearly lenacapavir for HIV prevention under priority review, with a target action date of June 19, 2025.  

Gilead Sciences, Inc. Price, Consensus and EPS Surprise

Gilead Sciences, Inc. price-consensus-eps-surprise-chart | Gilead Sciences, Inc. Quote

The European Medicines Agency validated the Marketing Authorization Application and EU-Medicines for All application for twice-yearly lenacapavir for HIV prevention.

The successful development and potential approval of lenacapavir for the prevention of the disease should solidify Gilead’s HIV franchise.  

Per GILD, lenacapavir, with its twice-yearly dosing, could set a new bar for HIV prevention and allow PrEP to reach out to a larger number of people who could benefit from a prevention regimen.

However, Biktarvy sales are expected to be under pressure due to Medicare Part D redesign, which, in turn, should affect overall HIV growth.

Gilead’s faces stiff competition from GSK plc GSK in the HIV space.

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 Novartis’ 2025 earnings per share (EPS) has risen from $8.46 to $8.74 over the past 60 days. EPS estimates for 2026 have jumped 35 cents to $9.02 during this timeframe. The stock has risen 24.7% 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 56.7%.

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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