Gilead Sciences (NasdaqGS:GILD) Gains FDA Approval For Yeztugo As PrEP HIV Option

Simply Wall St

Gilead Sciences (NasdaqGS:GILD) recently achieved FDA approval for Yeztugo, a significant step in HIV prevention as the first twice-yearly PrEP option in the U.S., supported by strong Phase 3 data. Although the company reported a return to profitability in its latest earnings, the stock's price movement was flat over the last quarter, aligning with the broader market's 9.9% annual uptick. This approval, along with positive clinical trial results for other treatments, would have added weight to these broader positive market trends, though the share buybacks and ongoing dividend declarations would have countered any downward pressures.

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NasdaqGS:GILD Revenue & Expenses Breakdown as at Jun 2025

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Gilead Sciences's recent FDA approval for Yeztugo, the first twice-yearly PrEP option in the U.S., comes at a crucial time and has the potential to significantly impact the company's narrative. This development could enhance their position in the HIV prevention market, possibly driving further revenue and earnings growth. Over the past three years, Gilead's total shareholder return reached 93%, indicating strong long-term performance. Compared to the US Biotechs industry, which saw a 9.9% decline over the past year, Gilead's shares exceeded expectations, highlighting their relative strength.

The approval bolsters confidence in Gilead's ongoing product launches, particularly lenacapavir and Trodelvy, positioning them to capture larger markets and support future revenue growth. Analysts anticipate their annual revenue growth to reach 5.7% with earnings projected to hit US$10.2 billion by 2028. With the current share price at US$97.88, the potential upside towards the fair value consensus at US$116.77, and the bullish target at US$140, indicates room for growth relative to analyst expectations. The approval adds weight to these projections, corroborating the company's strategy and affirming its innovation momentum in the biopharmaceutical industry.

In light of our recent valuation report, it seems possible that Gilead Sciences is trading behind its estimated value.

This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

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